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

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

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gingival Augmentation and Root Coverage Results With Superficial and Deep Cut Acellular Dermal Matrices
Actual Study Start Date : October 3, 2023
Actual Primary Completion Date : April 9, 2024
Actual Study Completion Date : April 9, 2024
Arms and Interventions
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Arm Intervention/treatment
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.
 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
Active Comparator: Test Group:Acellular 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 Name: Acellular Dermal Matrix-deep


Outcome Measures
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Primary Outcome Measures :
  1. Percentage root coverage [ Time Frame: Baseline to 12 months ]
    Measured as change in percentage root coverage

  2. Keratinized tissue width [ Time Frame: Baseline to 12 months ]
    Measured as change in keratinized tissue width


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05956496


Locations
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United States, Texas
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
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Principal Investigator: Angela Palaiologou-Gallis, DDS, MS University of Texas Health Science Center San Antonio
More Information
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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: July 21, 2023    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Individual Participant Data (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
Statistical Analysis Plan (SAP)
Time Frame: When summary data are published or otherwise made available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Angela Palaiologou-Gallis, DDS, MS, The University of Texas Health Science Center at San Antonio:
Gingival augmentation
Graft materials
Acellular dermal matrix (ADM)
Subepithelial connective tissue graft (SCTG)
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
 Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy