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

• ClinicalTrials.gov Identifier: NCT05956496
• Recruitment Status: Terminated
• First Posted: July 21, 2023
• Last Update Posted: April 11, 2024
• Sponsor: The University of Texas Health Science Center at San Antonio
• Information provided by (Responsible Party): Angela Palaiologou-Gallis, DDS, MS, The University of Texas Health Science Center at San Antonio

Tracking Information

• First Submitted Date: July 13, 2023
• First Posted Date: July 21, 2023
• Last Update Posted Date: April 11, 2024
• Actual Study Start Date: October 3, 2023
• Actual Primary Completion Date: April 9, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 13, 2023)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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.

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Gingival Recession

Intervention

• 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 Name: Acellular Dermal Matrix-superficial
• 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 Name: Acellular Dermal Matrix-deep

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 9, 2024): 6
• Original Estimated Enrollment (submitted: July 13, 2023): 20
• Actual Study Completion Date: April 9, 2024
• Actual Primary Completion Date: April 9, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 89 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05956496
• Other Study ID Numbers: HSC20230466H
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: All collected de-identified Individual Participant data (IPD) that underlie results in a publication
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Time Frame: When summary data are published or otherwise made available

• Current Responsible Party: Angela Palaiologou-Gallis, DDS, MS, The University of Texas Health Science Center at San Antonio
• Original Responsible Party: Same as current
• Current Study Sponsor: The University of Texas Health Science Center at San Antonio
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: The University of Texas Health Science Center at San Antonio
• Verification Date: April 2024