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

Sponsor

The University of Texas Health Science Center at San Antonio (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05956496

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gingival Recession	Other: Allograft Material ADM-S Other: Allograft Material ADM-D	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a split-mouth design randomized, prospective trial designed to compare two standard of care techniques.This is a split-mouth design randomized, prospective trial designed to compare two standard of care techniques.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Apr 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Group: Accellular Dermal Matrix - Superficial cut (ADM-S) 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.	Other: Allograft Material ADM-S 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. Other Names: Acellular Dermal Matrix-superficial
Active Comparator: Test Group:Accellular Dermal Matrix - Deep cut (ADM-D) The use of a deep cut ADM for root coverage gingival plastic procedures.	Other: Allograft Material ADM-D 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. Other Names: Acellular Dermal Matrix-deep

Arm

Intervention/Treatment

Placebo Comparator: Control Group: Accellular Dermal Matrix - Superficial cut (ADM-S)

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.

Other: Allograft Material ADM-S

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.

Other Names:

Acellular Dermal Matrix-superficial

Active Comparator: Test Group:Accellular Dermal Matrix - Deep cut (ADM-D)

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

Other: Allograft Material ADM-D

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.

Other Names:

Acellular Dermal Matrix-deep

Outcome Measures

Primary Outcome Measures

Percentage root coverage [Baseline to 12 months]
Measured as change in percentage root coverage
Keratinized tissue width [Baseline to 12 months]
Measured as change in keratinized tissue width

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Investigators

Principal Investigator: Angela Palaiologou-Gallis, DDS, MS, University of Texas Health Science Center San Antonio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Angela Palaiologou-Gallis, DDS, MS, Professor and Program Director, Graduate Periodontics, The University of Texas Health Science Center at San Antonio

ClinicalTrials.gov Identifier:

NCT05956496

Other Study ID Numbers:

HSC20230466H

First Posted:

Jul 21, 2023

Last Update Posted:

Jul 21, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Angela Palaiologou-Gallis, DDS, MS, Professor and Program Director, Graduate Periodontics, The University of Texas Health Science Center at San Antonio

Gingival augmentation

Graft materials

Accellular dermal matrix (ADM)

Subepithelial connective tissue graft (SCTG)

Additional relevant MeSH terms:

Gingival Recession

Study Results

No Results Posted as of Jul 21, 2023