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

• Sponsor: Perio Health Professionals, PLLC (Other)
• Overall Status: Completed
• CT.gov ID: NCT01952301
• Collaborator: (none)
• Enrollment: 30
• Arms: 2
• Duration (Months): 14

Study Details

Study Description

Brief Summary

A split-mouth study comparing soft tissue augmentation results using free gingival graft (FGG) versus xenogeneic collagen matrix (CM) for the generation of keratinized tissue (KT) around teeth with insufficient (< 2mm) KT.

Condition or Disease	Intervention/Treatment	Phase
Gingival Diseases	Device: Xenogeneic Collagen Matrix; Device: Free Gingival Graft	N/A

Detailed Description

A single-blind, randomized, controlled, split-mouth study of 30 subjects with insufficient zones of KT (< 2mm). The study utilized a within subject treatment comparison design to establish non-inferiority of the test (CM) versus control (FGG) therapy. The primary efficacy endpoint was KT width at 6-months. Secondary endpoints included traditional periodontal measures, such as clinical attachment, recession and bleeding on probing. Patient reported pain, discomfort and esthetic satisfaction were also recorded. Biopsies were obtained at 6-months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Controlled Clinical Trial to Evaluate a Xenogeneic Collagen Matrix as an Alternative to Free Gingival Grafting for Oral Soft Tissue Augmentation
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: xenogeneic collagen matrix Xenogeneic collagen matrix device placed on treatment wound bed site	Device: Xenogeneic Collagen Matrix; A type I and III porcine collagen matrix, as cleared by FDA (K012423)
Active Comparator: Free Gingival Graft Traditional free gingival graft (autogenous graft device harvested from patient's palate) placed on treatment site wound bed	Device: Free Gingival Graft; Autogenous, full-thickness soft tissue graft harvested from patient's palate.; Other Names: Free Autogenous Graft

Outcome Measures

Primary Outcome Measures

1. Keratinized Tissue Width [6 months]

   Change in Keratinized Tissue width

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• At least two non-adjacent teeth in contralateral quadrants of the same jaw with < 2mm of KT that requires soft tissue grafting (1-4 teeth may be treated). In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but all teeth will get the same treatment). The number of teeth treated must be the same on the test and control sites.

• Root coverage is not desired at the time of grafting.

• Females of childbearing potential must have a documented negative urine pregnancy test.

• Read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).

• Able and willing to follow study procedures and instructions.

• Multi-rooted teeth may be treated but will not be included as study teeth

Exclusion Criteria:

• Vestibule depth of less than 7mm from base of recession, and/or teeth with Miller Grade 2 or higher mobility.

• Any systemic conditions (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and/ or preclude periodontal surgery; or who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.

• Presence of acute infectious lesions in the areas intended for surgery.

• History of any tobacco use within the last six months.

• Taking intramuscular or intravenous bisphosphonates.

• Known hypersensitivity to collagen products, and/or allergy to iodine or shellfish.

• Participating in other clinical studies involving therapeutic intervention (either medical or dental).

• Previously undergone a gingival grafting procedure on the test or control teeth or the teeth adjacent to the study site.

• Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration following entrance into the study.

• Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Perio Health Professionals, PLLC

Investigators

• Principal Investigator: Michael K McGuire, DDS, Perio Health Professionals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael K McGuire, Michael K McGuire DDS, Perio Health Professionals, PLLC
• ClinicalTrials.gov Identifier: NCT01952301
• Other Study ID Numbers: 13562-007
• First Posted: Sep 27, 2013
• Last Update Posted: Jun 9, 2014
• Last Verified: May 1, 2014

• Keywords provided by Michael K McGuire, Michael K McGuire DDS, Perio Health Professionals, PLLC: Autologous; Collagen Matrix; Keratinized Tissue
• Additional relevant MeSH terms: Gingival Diseases

Study Results

Participant Flow

Recruitment Details	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

Arm/Group Title	XCM Versus FGG
Arm/Group Description	xenogeneic collagen matrix versus free gingival graft
Period Title: Overall Study
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Xenogeneic Collagen Matrix Versus Free Gingival Graft
Arm/Group Description	free gingival graft versus a xenogeneic collagen matrix over an apically positioned flap used to generate keratinized tissue
Overall Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	30 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.9 (11.2)
Sex: Female, Male (Count of Participants)
Female	6 20%
Male	24 80%
Region of Enrollment (participants) [Number]
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	Keratinized Tissue Width
Description	Change in Keratinized Tissue width
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Free Gingival Graft	Xenogeneic Collagen Matrix
Arm/Group Description	free gingival graft over an apically positioned flap used to generate keratinized tissue	xenogeneic collagen matrix over an apically positioned flap to generate keratinized tissue
Measure Participants	30	30
Mean (Standard Deviation) [mm]	4.42 (0.64)	2.92 (0.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Free Gingival Graft, Xenogeneic Collagen Matrix
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The primary hypothesis of the study evaluated whether CM was not inferior to Control in the generation of KT width from baseline to 6 months. A paired t-test was used to test for non-inferiority, using a one-sided significance level of 0.05 and a non-inferiority margin of 1.0 mm.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	Free Gingival Graft		Xenogeneic Collagen Matrix
Arm/Group Description	free gingival graft over an apically positioned flap used to generate keratinized tissue		xenogeneic collagen matrix over an apically positioned flap used to generate keratinized tissue
All Cause Mortality
	Free Gingival Graft		Xenogeneic Collagen Matrix
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Free Gingival Graft		Xenogeneic Collagen Matrix
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Free Gingival Graft		Xenogeneic Collagen Matrix
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.