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Use of a Collagen Membrane for Soft Tissue Grafting

Primary Purpose

Localized Gingival Recession

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Collagen Membrane
Sponsored by
Lauren M. F. Syrowik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Localized Gingival Recession

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Must have one to three consecutive teeth with recession and less than 1 mm of keratinized gingiva

Exclusion Criteria:

  • Asthma
  • Pregnancy
  • Uncontrolled diabetes
  • Use of continuous positive airway pressure (CPAP) machine for sleep apnea
  • Oral appliances (removable partial dentures, braces, mandibular advancement, bruxism splints, etc.)
  • Tobacco use
  • Immunocompromised individual

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Collagen membrane

Arm Description

First, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability.

Outcomes

Primary Outcome Measures

Change in depth of keratinized tissue
The amount of gingival augmentation will be assessed by the depth of keratinized tissue, measured in millimeters. Change in the amount of keratinized tissue in the areas of interest from baseline to 6 months will be tested to see if they are statistically significant.

Secondary Outcome Measures

Full Information

First Posted
July 30, 2014
Last Updated
January 5, 2016
Sponsor
Lauren M. F. Syrowik
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1. Study Identification

Unique Protocol Identification Number
NCT02206009
Brief Title
Use of a Collagen Membrane for Soft Tissue Grafting
Official Title
PriMatrix Dermal Repair Scaffold Utilization Intraorally
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lauren M. F. Syrowik

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Is PriMatrix wound dressing capable of regenerating gum tissue inside the mouth?
Detailed Description
PriMatrix is an acellular fetal bovine dermal matrix that has a wide array of FDA approved uses. These uses include partial- and full-thickness wounds, pressure, diabetic, and venous ulcers, surgical wounds, trauma wounds, tunneled wounds, and draining wounds. It is a sheet-like matrix made up primarily of type I and type III collagen. An increased proportion of type III collagen appears to play a key role in healing and regeneration. The use of extracellular dermal matrices is a relatively young field, and the exact mechanism by which PriMatrix promotes skin regeneration is still unknown. Despite this, PriMatrix has demonstrated differences in manufacturing and molecular composition that make it conducive to the harsh environments in which it has already been tested. Intraorally, where there is a rich vascular bed, this material holds exceeding promise. Utilizing this vascularity, autogenous free gingival grafts from the palate have already had their efficacy proven as a method of augmenting the keratinized tissue.The need to increase the keratinized tissue is based upon the postulation that less mobile, keratinized epithelium is more resilient than the non-keratinized oral mucosa. This is especially important in areas where recession and attachment loss has already occurred. Without having keratinized gingiva apical to the recession area, it has been suggested that there is a greater risk for more attachment loss to occur, thus reducing the support for the tooth. In addition, autogenous free gingival grafts have demonstrated the phenomenon of "creeping attachment" where a portion of the recession actually becomes covered as a result of grafting. While autogenous grafting is the gold standard in soft tissue augmentation, the amount of tissue that can be taken from the palate is limited, making it difficult to treat patients with generalized recession. Furthermore, a secondary surgical site increases the morbidity associated with the procedure. The hypothesis of this study is that PriMatrix will be able to provide similar results to an autogenous free gingival graft.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Gingival Recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Collagen membrane
Arm Type
Experimental
Arm Description
First, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability.
Intervention Type
Device
Intervention Name(s)
Collagen Membrane
Other Intervention Name(s)
PriMatrix
Intervention Description
First, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability.
Primary Outcome Measure Information:
Title
Change in depth of keratinized tissue
Description
The amount of gingival augmentation will be assessed by the depth of keratinized tissue, measured in millimeters. Change in the amount of keratinized tissue in the areas of interest from baseline to 6 months will be tested to see if they are statistically significant.
Time Frame
baseline, approximately 6 months after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must have one to three consecutive teeth with recession and less than 1 mm of keratinized gingiva Exclusion Criteria: Asthma Pregnancy Uncontrolled diabetes Use of continuous positive airway pressure (CPAP) machine for sleep apnea Oral appliances (removable partial dentures, braces, mandibular advancement, bruxism splints, etc.) Tobacco use Immunocompromised individual
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Assad, DDS
Organizational Affiliation
Mayo Clinic
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lauren MF Syrowik, DDS
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Use of a Collagen Membrane for Soft Tissue Grafting

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