Trial Outcomes & Findings for Xenogeneic Collagen Matrix as an Alternative to Free Gingival Grafting for Oral Soft Tissue Augmentation (NCT NCT01952301)

Results Overview

Change in Keratinized Tissue width

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

6 months

Results posted on

2014-06-09

Participant Flow

Our study sample was derived from the population of patients who presented at our practice between 11-3-2010 and 3-16-2011 and met predetermined selection criteria

Participant milestones

Participant milestones
Measure	XCM Versus FGG xenogeneic collagen matrix versus free gingival graft
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Xenogeneic Collagen Matrix as an Alternative to Free Gingival Grafting for Oral Soft Tissue Augmentation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Xenogeneic Collagen Matrix Versus Free Gingival Graft n=30 Participants free gingival graft versus a xenogeneic collagen matrix over an apically positioned flap used to generate keratinized tissue
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	51.9 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Sample size was determined using 80% power fans assuming a paired t-test of non-inferiority with a non-inferiority margin of 1.0 mm, a within-subject standard deviation of 1.0 mm, and a one-sided alpha of 0.05, resulting in a sample size of 27. To account for potential loss-to-follow-up, 30 subjects were enrolled in the trial.

Change in Keratinized Tissue width

Outcome measures

Outcome measures
Measure	Free Gingival Graft n=30 Participants free gingival graft over an apically positioned flap used to generate keratinized tissue	Xenogeneic Collagen Matrix n=30 Participants xenogeneic collagen matrix over an apically positioned flap to generate keratinized tissue
Keratinized Tissue Width	4.42 mm Standard Deviation 0.64	2.92 mm Standard Deviation 0.88

Adverse Events

Free Gingival Graft

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Xenogeneic Collagen Matrix

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

Dr. Michael K. McGuire

Perio Health Professionals, PLLC

Phone: 713-783-5442

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place