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Gingival Augmentation and Root Coverage With Superficial and Deep Cut Acellular Dermal Matrices

Primary Purpose

Gingival Recession

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Allograft Material ADM-S
Allograft Material ADM-D
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Gingival augmentation, Graft materials, Acellular dermal matrix (ADM), Subepithelial connective tissue graft (SCTG)

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients between age 18 and 89 Patients needing root coverage procedures for gingival recession in one or more teeth in the same arch bilaterally (split mouth) Patients must be nonsmokers, former smokers, or current smokers who smoke <10 cigarettes per day, by self-report. Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential. Exclusion Criteria: Patients who disclose that they will not be able to cooperate with the follow-up schedule. Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report) Pregnant women or women intending to become pregnant during study period. Smokers who smoke > 10 cigarettes per day

Sites / Locations

  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control Group: Acellular Dermal Matrix - Superficial cut (ADM-S)

Test Group:Acellular Dermal Matrix - Deep cut (ADM-D)

Arm Description

A commonly used allograft material is the Acellular Dermal Matrix (ADM) which is harvested from human donor dermal tissues. Most commercially available ADM products are superficial cuts.

The use of a deep cut ADM for root coverage gingival plastic procedures.

Outcomes

Primary Outcome Measures

Percentage root coverage
Measured as change in percentage root coverage
Keratinized tissue width
Measured as change in keratinized tissue width

Secondary Outcome Measures

Full Information

First Posted
July 13, 2023
Last Updated
August 1, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT05956496
Brief Title
Gingival Augmentation and Root Coverage With Superficial and Deep Cut Acellular Dermal Matrices
Official Title
Gingival Augmentation and Root Coverage Results With Superficial and Deep Cut Acellular Dermal Matrices
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. Patients needing root coverage for gingival recession will be enrolled.
Detailed Description
Each subject will be randomized to one of the treatments for the first side and the contralateral side will receive the other treatment. No risk or benefit is expected from being assigned to either group as both procedures are both standard care. In both groups, a commercially available allograft (ADM-D or ADM-S) will be used. Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes. Grafting teeth with gingival recession is often done to improve esthetics and tooth sensitivity as well as prevent recession from progressing. When recession coverage procedures are done, a soft tissue graft material is inserted between the gums and the tooth to help decrease the amount of root exposure. This material is obtained from a donor and may originate from a deeper or shallower layer of the donor skin. The study team seek to determine if the origin of the graft material (deep or shallow) influences the amount of root coverage achieved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Gingival augmentation, Graft materials, Acellular dermal matrix (ADM), Subepithelial connective tissue graft (SCTG)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a split-mouth design randomized, prospective trial designed to compare two standard of care techniques.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group: Acellular Dermal Matrix - Superficial cut (ADM-S)
Arm Type
Placebo Comparator
Arm Description
A commonly used allograft material is the Acellular Dermal Matrix (ADM) which is harvested from human donor dermal tissues. Most commercially available ADM products are superficial cuts.
Arm Title
Test Group:Acellular Dermal Matrix - Deep cut (ADM-D)
Arm Type
Active Comparator
Arm Description
The use of a deep cut ADM for root coverage gingival plastic procedures.
Intervention Type
Other
Intervention Name(s)
Allograft Material ADM-S
Other Intervention Name(s)
Acellular Dermal Matrix-superficial
Intervention Description
A piece of the allograft material (ADM-D) will be hydrated per the manufacturers guidelines and adapted to the recipient area after reflection of a partial thickness flap. The flap will be coronally advanced to completely cover the graft material per standard care for this procedure.
Intervention Type
Other
Intervention Name(s)
Allograft Material ADM-D
Other Intervention Name(s)
Acellular Dermal Matrix-deep
Intervention Description
A piece of the allograft material (ADM-S) will be hydrated per the manufacturers guidelines and adapted to the recipient area after reflection of a partial thickness flap. The flap will be coronally advanced to completely cover the graft material per standard care for this procedure.
Primary Outcome Measure Information:
Title
Percentage root coverage
Description
Measured as change in percentage root coverage
Time Frame
Baseline to 12 months
Title
Keratinized tissue width
Description
Measured as change in keratinized tissue width
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients between age 18 and 89 Patients needing root coverage procedures for gingival recession in one or more teeth in the same arch bilaterally (split mouth) Patients must be nonsmokers, former smokers, or current smokers who smoke <10 cigarettes per day, by self-report. Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential. Exclusion Criteria: Patients who disclose that they will not be able to cooperate with the follow-up schedule. Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report) Pregnant women or women intending to become pregnant during study period. Smokers who smoke > 10 cigarettes per day
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Palaiologou-Gallis, DDS, MS
Phone
210-567 3567
Email
palaiologoua@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Palaiologou-Gallis, DDS, MS
Organizational Affiliation
University of Texas Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected de-identified Individual Participant data (IPD) that underlie results in a publication
IPD Sharing Time Frame
When summary data are published or otherwise made available

Learn more about this trial

Gingival Augmentation and Root Coverage With Superficial and Deep Cut Acellular Dermal Matrices

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