Trial Outcomes & Findings for Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration (NCT NCT00587834)

NCT ID: NCT00587834

Last Updated: 2012-11-08

Results Overview

The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

96 participants

Primary outcome timeframe

6 months

Results posted on

2012-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	Gintuit and Autologous Free Gingival Graft (FGG) Single application of Gintuit and FGG (control); split-mouth design
Overall Study STARTED	96
Overall Study COMPLETED	96
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gintuit and Autologous Free Gingival Graft (FGG) n=96 Participants Single application of Gintuit and FGG (control); split-mouth design
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	87 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age Continuous	47.14 years STANDARD_DEVIATION 13.13 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	85 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 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	1 Participants n=5 Participants
Race (NIH/OMB) White	87 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	96 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Per protocol the first 2 subjects per Investigator were training subjects and evaluated for safety only. There were 11 training subjects and the remaining 85 subjects were analyzed for all efficacy outcomes.

The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months.

Outcome measures

Outcome measures
Measure	Gintuit n=85 Participants Single application;split-mouth design	Gintuit Not Equally Red as Adjacent Tissue Not Equally Red includes responses of "more red" and "less red"
Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.	95.3 percentage of participants Interval 88.4 to 98.7	—

SECONDARY outcome

Timeframe: 6 months

Population: See description in primary outcome measure.

An examiner assessed color of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as "More Red", "Equally Red", or "Less Red" as compared to adjacent, non-treated tissue. A match in color with the surrounding tissue is considered a positive aesthetic outcome.

Outcome measures

Outcome measures
Measure	Gintuit n=85 Participants Single application;split-mouth design	Gintuit Not Equally Red as Adjacent Tissue n=85 Participants Not Equally Red includes responses of "more red" and "less red"
Color Same as Adjacent Tissues After 6 Months (Superiority) Control Equally Red as Adjacent Tissue	23 Participants	0 Participants
Color Same as Adjacent Tissues After 6 Months (Superiority) Control Not Equally Red as Adjacent Tissue	56 Participants	6 Participants

SECONDARY outcome

Timeframe: 6 months

Population: See description in primary outcome measures.

An examiner assessed texture of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as "More Firm", "Equally Firm", or "Less Firm" as compared to adjacent, non-treated tissue. A match in texture with the surrounding tissue is considered a positive aesthetic outcome.

Outcome measures

Outcome measures
Measure	Gintuit n=85 Participants Single application;split-mouth design	Gintuit Not Equally Red as Adjacent Tissue n=85 Participants Not Equally Red includes responses of "more red" and "less red"
Texture Same as Adjacent Tissues After 6 Months (Superiority) Control Equally Firm as Adjacent Tissue	46 Participants	0 Participants
Texture Same as Adjacent Tissues After 6 Months (Superiority) Control Not Equally Firm as Adjacent Tissue	35 Participants	4 Participants

SECONDARY outcome

Timeframe: 6 months

Population: See description in primary outcome measure.

The superiority of Gintuit relative to a pre-defined standard (80% success) for a 1 mm KT threshold after six months.

Outcome measures

Outcome measures
Measure	Gintuit n=85 Participants Single application;split-mouth design	Gintuit Not Equally Red as Adjacent Tissue Not Equally Red includes responses of "more red" and "less red"
Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.	100 Percentage of Participants Interval 95.8 to 100.0	—

SECONDARY outcome

Timeframe: 6 months

Population: See description in primary outcome measure.

Number of patients expressing preference for Gintuit.

Outcome measures

Outcome measures
Measure	Gintuit n=85 Participants Single application;split-mouth design	Gintuit Not Equally Red as Adjacent Tissue Not Equally Red includes responses of "more red" and "less red"
Patient Preference After 6 Months/Early Termination (Superiority)	61 participants Interval 61.0 to 81.0	—

SECONDARY outcome

Timeframe: 6 months

Population: See description in primary outcome measures. The presence of Coe-Pak (protective periodontal dressing) at Week 1 prohibited the assessment of sensitivity for 14 subjects. The analysis was performed on 71 of the 85 subjects evaluated for efficacy.

The sensitivity of Gintuit, Free Gingival Graft (FGG) and palatal donation sites was assessed with a puff of air and rated by the Investigator as none, mild, moderate or severe sensitivity. The sensitivity of Control was determined as the most sensitive of FGG and palatal donation sites.

Outcome measures

Outcome measures
Measure	Gintuit n=71 Participants Single application;split-mouth design	Gintuit Not Equally Red as Adjacent Tissue n=71 Participants Not Equally Red includes responses of "more red" and "less red"
Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority) Control Not Sensitive	67 Participants	3 Participants
Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority) Control Sensitive	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 3

Pain Assessment(Modified Intent-to-Treat Population)

Outcome measures

Outcome data not reported

Adverse Events

Gintuit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Free Gingival Graft

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Palatal Donation Site

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mouth

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Other

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gintuit n=96 participants at risk Adverse events occurring at the Gintuit treated site	Free Gingival Graft n=96 participants at risk Adverse events occurring at the autologous free gingival graft site	Palatal Donation Site n=96 participants at risk Adverse events occurring at the palatal donation site	Mouth n=96 participants at risk Adverse events occurring in the mouth and not localized to the Gintuit, FGG, or palatal donation sites.	Other n=96 participants at risk Adverse events occurring at any other location in the body or systemic conditions
Infections and infestations Pneumonia	0.00% 0/96 • 6 months	0.00% 0/96 • 6 months	0.00% 0/96 • 6 months	0.00% 0/96 • 6 months	1.0% 1/96 • Number of events 1 • 6 months
General disorders Chest Pains	0.00% 0/96 • 6 months	0.00% 0/96 • 6 months	0.00% 0/96 • 6 months	0.00% 0/96 • 6 months	1.0% 1/96 • Number of events 1 • 6 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Metastatic Fibrous Histiocytoma	0.00% 0/96 • 6 months	0.00% 0/96 • 6 months	0.00% 0/96 • 6 months	0.00% 0/96 • 6 months	1.0% 1/96 • Number of events 1 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Operations

Organogenesis Inc.

Phone: 781-575-0775

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor can review communications prior to public release and can embargo communications regarding trial results for at least 30 days in advance of public release. The sponsor can request removal of any confidential or proprietary information provided by sponsor and extend such review period for another 90 days to file patent applications or take other steps to protect the sponsor's intellectual property interests.
Publication restrictions are in place

Restriction type: OTHER