Trial Outcomes & Findings for Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site (NCT NCT03713073)

NCT ID: NCT03713073

Last Updated: 2022-01-19

Results Overview

The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: baseline
• Results posted on: 2022-01-19

Participant Flow

Unit of analysis: palatal wound site

Participant milestones

Measure	All Participants The study is a "split-mouth design." For each participant, there were 2 palatal wound sites (one on the right side and one on the left side), and for each participant, allogenic amnion chorion membrane (ACM) was placed on one of the wound sites and collagen dressing was placed on the other wound site. In other words, each participant received both interventions, and the interventions were received at the same time. The side of placement of the two interventions was randomized. Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Collagen dressing is used to cover wounds in dental surgery.
Overall Study STARTED	19 38
Overall Study Allogenic Amnion Chorion Membrane	19 19
Overall Study Collagen Dressing	19 19
Overall Study COMPLETED	19 38
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site

Baseline characteristics by cohort

Measure	All Participants n=19 Participants The study is a "split-mouth design." For each participant, there were 2 palatal wound sites (one on the right side and one on the left side), and for each participant, allogenic amnion chorion membrane (ACM) was placed on one of the wound sites and collagen dressing was placed on the other wound site. In other words, each participant received both interventions, and the interventions were received at the same time. The side of placement of the two interventions was randomized. Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Collagen dressing is used to cover wounds in dental surgery.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	54.55 years STANDARD_DEVIATION 11.16 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	19 Participants n=5 Participants
Body mass index (BMI) 18.5-24.9 kg/m²	13 Participants n=5 Participants
Body mass index (BMI) 25-29.9 kg/m²	2 Participants n=5 Participants
Body mass index (BMI) greater than 30 kg/m²	4 Participants n=5 Participants
Number of participants with hypertension	4 Participants n=5 Participants
Number of participants who currently smoke	1 Participants n=5 Participants
Physical status as indicated by American Society of Anesthesiologists (ASA) Class ASA class I	10 Participants n=5 Participants
Physical status as indicated by American Society of Anesthesiologists (ASA) Class ASA class II	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Size of Wound Area	80 micrometers (μm) Standard Deviation 0	80 micrometers (μm) Standard Deviation 0

PRIMARY outcome

Timeframe: 4 days

The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Size of Wound Area	35.9 micrometers (μm) Standard Deviation 12.2	37.3 micrometers (μm) Standard Deviation 12.9

PRIMARY outcome

Timeframe: 10 days

Population: Data for this outcome were not collected for four in the allogenic amnion chorion membrane arm and four in the collagen dressing arm.

The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=15 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=15 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Size of Wound Area	22.9 micrometers (μm) Standard Deviation 10.7	25.6 micrometers (μm) Standard Deviation 10.2

PRIMARY outcome

Timeframe: 14 days

Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.

The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=18 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=18 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Size of Wound Area	13.3 micrometers (μm) Standard Deviation 9.1	14.1 micrometers (μm) Standard Deviation 7.9

PRIMARY outcome

Timeframe: 21 days

Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.

The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=18 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=18 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Size of Wound Area	2.8 micrometers (μm) Standard Deviation 3.4	4.1 micrometers (μm) Standard Deviation 4.1

PRIMARY outcome

Timeframe: 28 days

Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.

The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=18 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=18 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Size of Wound Area	0 micrometers (μm) Standard Deviation 0	0.25 micrometers (μm) Standard Deviation 1.0

PRIMARY outcome

Timeframe: 45 days

The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Size of Wound Area	0 micrometers (μm) Standard Deviation 0	0 micrometers (μm) Standard Deviation 0

PRIMARY outcome

Timeframe: 60 days

The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Size of Wound Area	0 micrometers (μm) Standard Deviation 0	0 micrometers (μm) Standard Deviation 0

SECONDARY outcome

Timeframe: baseline

Population: Data were not collected at this time point for this outcome measure.

Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 days

Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm.

Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=18 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Number of Participants Stratified as Per the Degree of Epithelialization of Wound no epithelialization	18 Participants	19 Participants
Number of Participants Stratified as Per the Degree of Epithelialization of Wound partial epithelialization	0 Participants	0 Participants
Number of Participants Stratified as Per the Degree of Epithelialization of Wound total epithelialization	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 10 days

Population: Data for this outcome were not collected for three in the allogenic amnion chorion membrane arm and four in the collagen dressing arm.

Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=16 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=15 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Number of Participants Stratified as Per the Degree of Epithelialization of Wound no epithelialization	0 Participants	0 Participants
Number of Participants Stratified as Per the Degree of Epithelialization of Wound partial epithelialization	15 Participants	15 Participants
Number of Participants Stratified as Per the Degree of Epithelialization of Wound total epithelialization	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 14 days

Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.

Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=18 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=18 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Number of Participants Stratified as Per the Degree of Epithelialization of Wound no epithelialization	0 Participants	0 Participants
Number of Participants Stratified as Per the Degree of Epithelialization of Wound partial epithelialization	7 Participants	7 Participants
Number of Participants Stratified as Per the Degree of Epithelialization of Wound total epithelialization	11 Participants	11 Participants

SECONDARY outcome

Timeframe: 21 days

Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and seven in the collagen dressing arm.

Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=18 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=11 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Number of Participants Stratified as Per the Degree of Epithelialization of Wound no epithelialization	0 Participants	0 Participants
Number of Participants Stratified as Per the Degree of Epithelialization of Wound partial epithelialization	1 Participants	0 Participants
Number of Participants Stratified as Per the Degree of Epithelialization of Wound total epithelialization	17 Participants	11 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.

Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=18 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=18 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Number of Participants Stratified as Per the Degree of Epithelialization of Wound no epithelialization	0 Participants	0 Participants
Number of Participants Stratified as Per the Degree of Epithelialization of Wound partial epithelialization	0 Participants	0 Participants
Number of Participants Stratified as Per the Degree of Epithelialization of Wound total epithelialization	18 Participants	18 Participants

SECONDARY outcome

Timeframe: 45 days

Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Number of Participants Stratified as Per the Degree of Epithelialization of Wound no epithelialization	0 Participants	0 Participants
Number of Participants Stratified as Per the Degree of Epithelialization of Wound partial epithelialization	0 Participants	0 Participants
Number of Participants Stratified as Per the Degree of Epithelialization of Wound total epithelialization	19 Participants	19 Participants

SECONDARY outcome

Timeframe: 60 days

Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Number of Participants Stratified as Per the Degree of Epithelialization of Wound no epithelialization	0 Participants	0 Participants
Number of Participants Stratified as Per the Degree of Epithelialization of Wound partial epithelialization	0 Participants	0 Participants
Number of Participants Stratified as Per the Degree of Epithelialization of Wound total epithelialization	19 Participants	19 Participants

SECONDARY outcome

Timeframe: baseline

Population: Data were not collected at this time point for this outcome measure.

The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 days

The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva obvious difference	19 Participants	19 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva noticeable difference	0 Participants	0 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva disguisable difference	0 Participants	0 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva no noticeable difference	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 10 days

Population: Data for this outcome were not collected for four in the allogenic amnion chorion membrane arm and four in the collagen dressing arm.

The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=15 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=15 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva obvious difference	15 Participants	15 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva noticeable difference	0 Participants	0 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva disguisable difference	0 Participants	0 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva no noticeable difference	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 14 days

Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.

The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=18 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=18 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva obvious difference	5 Participants	10 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva noticeable difference	12 Participants	6 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva disguisable difference	1 Participants	2 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva no noticeable difference	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 21 days

Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.

The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=18 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=18 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva obvious difference	0 Participants	0 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva noticeable difference	6 Participants	7 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva disguisable difference	7 Participants	10 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva no noticeable difference	5 Participants	1 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Data for this outcome were not collected for three in the allogenic amnion chorion membrane arm and three in the collagen dressing arm.

The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=16 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=16 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva obvious difference	0 Participants	0 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva noticeable difference	0 Participants	2 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva disguisable difference	9 Participants	12 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva no noticeable difference	7 Participants	2 Participants

SECONDARY outcome

Timeframe: 45 days

Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.

The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=18 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=18 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva obvious difference	0 Participants	0 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva noticeable difference	0 Participants	0 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva disguisable difference	4 Participants	6 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva no noticeable difference	14 Participants	12 Participants

SECONDARY outcome

Timeframe: 60 days

The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva obvious difference	0 Participants	0 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva noticeable difference	0 Participants	0 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva disguisable difference	2 Participants	3 Participants
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva no noticeable difference	17 Participants	16 Participants

SECONDARY outcome

Timeframe: baseline

Population: Data were not collected at this time point for this outcome measure.

Haemostasis is achieved when no bleeding of the wound site is actively seen.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 days

Haemostasis is achieved when no bleeding of the wound site is actively seen.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Number of Participants With Haemostasis of Wound Area	19 Participants	19 Participants

SECONDARY outcome

Timeframe: 10 days

Haemostasis is achieved when no bleeding of the wound site is actively seen.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Number of Participants With Haemostasis of Wound Area	18 Participants	19 Participants

SECONDARY outcome

Timeframe: 14 days

Haemostasis is achieved when no bleeding of the wound site is actively seen.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Number of Participants With Haemostasis of Wound Area	18 Participants	18 Participants

SECONDARY outcome

Timeframe: 21 days

Haemostasis is achieved when no bleeding of the wound site is actively seen.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Number of Participants With Haemostasis of Wound Area	19 Participants	19 Participants

SECONDARY outcome

Timeframe: 28 days

Haemostasis is achieved when no bleeding of the wound site is actively seen.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Number of Participants With Haemostasis of Wound Area	19 Participants	19 Participants

SECONDARY outcome

Timeframe: 45 days

Haemostasis is achieved when no bleeding of the wound site is actively seen.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Number of Participants With Haemostasis of Wound Area	19 Participants	19 Participants

SECONDARY outcome

Timeframe: 60 days

Haemostasis is achieved when no bleeding of the wound site is actively seen.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Number of Participants With Haemostasis of Wound Area	19 Participants	19 Participants

SECONDARY outcome

Timeframe: baseline

Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Pain as Assessed by a Visual Analogue Scale (VAS)	7.89 units on a scale Standard Deviation 2.13	7.89 units on a scale Standard Deviation 2.13

SECONDARY outcome

Timeframe: 4 days

Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Pain as Assessed by a Visual Analogue Scale (VAS)	4.42 units on a scale Standard Deviation 1.57	4.42 units on a scale Standard Deviation 1.57

SECONDARY outcome

Timeframe: 10 days

Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Pain as Assessed by a Visual Analogue Scale (VAS)	1.63 units on a scale Standard Deviation 2.31	1.63 units on a scale Standard Deviation 2.31

SECONDARY outcome

Timeframe: 14 days

Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Pain as Assessed by a Visual Analogue Scale (VAS)	0.53 units on a scale Standard Deviation 1.26	0.53 units on a scale Standard Deviation 1.26

SECONDARY outcome

Timeframe: 21 days

Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Pain as Assessed by a Visual Analogue Scale (VAS)	0.32 units on a scale Standard Deviation 1.00	0.32 units on a scale Standard Deviation 1.00

SECONDARY outcome

Timeframe: 28 days

Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Pain as Assessed by a Visual Analogue Scale (VAS)	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 45 days

Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Pain as Assessed by a Visual Analogue Scale (VAS)	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 60 days

Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Pain as Assessed by a Visual Analogue Scale (VAS)	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: baseline

Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensitivity based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) no loss of sensation	19 Participants	19 Participants
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) mild/moderate loss of sensation	0 Participants	0 Participants
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) severe loss of sensation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 days

Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) no loss of sensation	19 Participants	19 Participants
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) mild/moderate loss of sensation	0 Participants	0 Participants
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) severe loss of sensation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 10 days

Population: Data for this outcome were not collected for four in the allogenic amnion chorion membrane arm and four in the collagen dressing arm.

Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=15 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=15 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) no loss of sensation	15 Participants	15 Participants
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) mild/moderate loss of sensation	0 Participants	0 Participants
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) severe loss of sensation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 14 days

Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.

Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=18 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=18 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) no loss of sensation	18 Participants	18 Participants
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) mild/moderate loss of sensation	0 Participants	0 Participants
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) severe loss of sensation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 21 days

Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.

Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=18 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=18 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) no loss of sensation	18 Participants	18 Participants
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) mild/moderate loss of sensation	0 Participants	0 Participants
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) severe loss of sensation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.

Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=18 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=18 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) no loss of sensation	18 Participants	18 Participants
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) mild/moderate loss of sensation	0 Participants	0 Participants
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) severe loss of sensation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 45 days

Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) no loss of sensation	19 Participants	19 Participants
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) mild/moderate loss of sensation	0 Participants	0 Participants
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) severe loss of sensation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 60 days

Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) no loss of sensation	19 Participants	19 Participants
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) mild/moderate loss of sensation	0 Participants	0 Participants
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) severe loss of sensation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: baseline

Population: There is not enough usable data collected for any participant to summarize and report this outcome measure accurately.

The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 days

Population: There is not enough usable data collected for any participant to summarize and report this outcome measure accurately.

The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 days

Population: There is not enough usable data collected for any participant to summarize and report this outcome measure accurately.

The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

Population: There is not enough usable data collected for any participant to summarize and report this outcome measure accurately.

The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 21 days

Population: There is not enough usable data collected for any participant to summarize and report this outcome measure accurately.

The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: There is not enough usable data collected for any participant to summarize and report this outcome measure accurately.

The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 45 days

Population: There is not enough usable data collected for any participant to summarize and report this outcome measure accurately.

The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 days

Population: There is not enough usable data collected for any participant to summarize and report this outcome measure accurately.

The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at the time of placement of the wound dressing material

Population: Data for this outcome measure were not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline

Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections	62.1 neutrophil cells Standard Deviation 29.9	65 neutrophil cells Standard Deviation 22.6

SECONDARY outcome

Timeframe: 10 days

Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and two in the collagen dressing arm.

Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=18 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=17 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections	80 neutrophil cells/field Standard Deviation 47.7	88 neutrophil cells/field Standard Deviation 35.8

SECONDARY outcome

Timeframe: baseline, 10 days

Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=18 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=18 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Change in Percentage of Collagen Density in Wound Area as Assessed by Light Microscopy of Masson's Trichrome-stained Biopsy Sections	1.15 percentage of collagen density Standard Deviation 2.41	3.38 percentage of collagen density Standard Deviation 2.63

SECONDARY outcome

Timeframe: baseline

Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope, and Nikon NIS-Elements Advanced Research (AR) Imagine Software will be used to calculate the thickness of the epithelium.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections	302.2 micrometers (μm) Standard Deviation 95.2	291 micrometers (μm) Standard Deviation 79.7

SECONDARY outcome

Timeframe: 10 days

Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and two in the collagen dressing arm.

Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope, and Nikon NIS-Elements Advanced Research (AR) Imagine Software will be used to calculate the thickness of the epithelium.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=18 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=17 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections	339.6 micrometers (μm) Standard Deviation 94.4	339.3 micrometers (μm) Standard Deviation 118.6

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=19 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=19 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Angiogenesis as Indicated by Number of Blood Vessels as Assessed by Light Microscopy of Biopsy Sections Immunohistochemically Stained to Detect Factor VIII (Von Willebrandt Factor)	4.9 blood vessels/field Standard Deviation 1.9	5.4 blood vessels/field Standard Deviation 2.2

SECONDARY outcome

Timeframe: 10 days

Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and two in the collagen dressing arm.

Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope, and the area of angiogenesis will be quantified using Nikon NIS Element AR Imagine Software.

Outcome measures

Measure	Allogenic Amnion Chorion Membrane n=18 Participants Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Allogenic amnion chorion membrane: Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Collagen Dressing n=17 Participants Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery.
Angiogenesis as Indicated by Number of Blood Vessels as Assessed by Light Microscopy of Biopsy Sections Immunohistochemically Stained to Detect Factor VIII (Von Willebrandt Factor)	4.4 blood vessels/field Standard Deviation 2	5.1 blood vessels/field Standard Deviation 2

Adverse Events

Allogenic Amnion Chorion Membrane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Collagen Dressing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chun-Teh Lee, DDS, DMSc, MS

The University of Texas Health Science Center at Houston

Phone: 713-486-4384

Email: Chun-Teh.Lee@uth.tmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place