Trial Outcomes & Findings for To Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa (NCT NCT03338686)

Last Updated: 2021-09-22

Results Overview

Compare the increase in keratinized mucosa (KM) between two commonly used soft tissue grafting techniques (FGG and CTG) by quantifying KM widths (in mm) at 12 months following soft tissue grafting.

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

From baseline to 12 months

Results posted on

2021-09-22

Participant Flow

Randomization was performed by site in the mouth (dental implant) to receive either FGG intervention or CTG intervention. As a result, some participants received only one of the 2 interventions if they only had one qualifying site (=dental implant) while other participants received both interventions if they had multiple implants that met the inclusion criteria. Total FGG implant sites=14, total CTG sites=12.

Unit of analysis: implants

Participant milestones

Participant milestones
Measure	Free Gingival Graft Free Gingival Graft (FGG) Free Gingival Graft (FGG): Free Gingival Graft (FGG) was performed on all study sites in this arm.	Connective Tissue Graft Followed by Laser Gingivoplasty Connective Tissue Graft (CTG) followed by Laser Gingivoplasty Connective Tissue Graft followed by Laser Gingivoplasty: Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm.	FGG + CTG Both FGG and CTG (at different implants in the same patient)
Overall Study STARTED	2 2	5 5	7 19
Overall Study COMPLETED	2 2	5 5	7 19
Overall Study NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

To Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Free Gingival Graft n=2 implants Free Gingival Graft (FGG) Free Gingival Graft (FGG): Free Gingival Graft (FGG) was performed on all study sites in this arm.	Connective Tissue Graft Followed by Laser Gingivoplasty n=5 implants Connective Tissue Graft (CTG) followed by Laser Gingivoplasty Connective Tissue Graft followed by Laser Gingivoplasty: Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm.	FGG + CTG n=19 implants Both FGG and CTG (at different implants in the same patient)	Total n=26 implants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: From baseline to 12 months

Population: FGG group has 2 participants who only received FGG (n=2) and 7 participants who received FGG (n=12) and CTG at different implant sites (total of 14=2+12). CTG group has 5 participants who only received CTG (n=5) and 7 participants who received FGG and CTG (n=7) at different implant sites (total of 12=5+7).

Compare the increase in keratinized mucosa (KM) between two commonly used soft tissue grafting techniques (FGG and CTG) by quantifying KM widths (in mm) at 12 months following soft tissue grafting.

Outcome measures

Outcome measures
Measure	Free Gingival Graft n=14 implants Free Gingival Graft (FGG) Free Gingival Graft (FGG): Free Gingival Graft (FGG) was performed on all study sites in this arm.	Connective Tissue Graft Followed by Laser Gingivoplasty n=12 implants Connective Tissue Graft (CTG) followed by Laser Gingivoplasty Connective Tissue Graft followed by Laser Gingivoplasty: Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm.
The Increase in Keratinized Mucosa (in mm) Between the Two Grafts	3.29 mm Standard Deviation 1.88	1.29 mm Standard Deviation 1.05

SECONDARY outcome

Timeframe: From baseline to 12 months

Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting.

Outcome measures

Outcome measures
Measure	Free Gingival Graft n=14 implant sites Free Gingival Graft (FGG) Free Gingival Graft (FGG): Free Gingival Graft (FGG) was performed on all study sites in this arm.	Connective Tissue Graft Followed by Laser Gingivoplasty n=12 implant sites Connective Tissue Graft (CTG) followed by Laser Gingivoplasty Connective Tissue Graft followed by Laser Gingivoplasty: Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm.
Measure Changes in Tissue Thickness at 2mm From GM (in mm) Between FGG and CTG	0.21 mm Standard Deviation 0.98	0.38 mm Standard Deviation 0.8

SECONDARY outcome

Timeframe: From baseline to 12 months

Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting.

Outcome measures

Outcome measures
Measure	Free Gingival Graft n=14 implant sites Free Gingival Graft (FGG) Free Gingival Graft (FGG): Free Gingival Graft (FGG) was performed on all study sites in this arm.	Connective Tissue Graft Followed by Laser Gingivoplasty n=12 implant sites Connective Tissue Graft (CTG) followed by Laser Gingivoplasty Connective Tissue Graft followed by Laser Gingivoplasty: Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm.
Measure Changes in Tissue Thickness at 5mm From GM (in mm) Between FGG and CTG	0.21 mm Standard Deviation 0.75	0.79 mm Standard Deviation 0.58

Adverse Events

Free Gingival Graft

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Connective Tissue Graft Followed by Laser Gingivoplasty

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

FGG + CTG

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

Ramzi Abou-Arraj

University of Alabama at Birmingham

Phone: 2059344506

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place