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

Not Applicable

Terminated

• Conditions: Gingival Recession
• Interventions: Other: Allograft Material ADM-S; Other: Allograft Material ADM-D

• Registration Number: NCT05956496
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Study Timeline

• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-21
• Study Start: 2023-10-03
• Status Verified: 2024-04
• Primary Completion: 2024-04-09
• Study Completion: 2024-04-09
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group: Acellular Dermal Matrix - Superficial cut (ADM-S)	Allograft Material 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.
Test Group:Acellular Dermal Matrix - Deep cut (ADM-D)	Allograft Material ADM-D	The use of a deep cut ADM for root coverage gingival plastic procedures.

Primary Outcome Measures

Name	Time	Method
Keratinized tissue width	Baseline to 12 months	Measured as change in keratinized tissue width
Percentage root coverage	Baseline to 12 months	Measured as change in percentage root coverage

Trial Locations

Locations (1)

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States