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

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05956496
• Other study ID #: HSC20230466H
• Status: Terminated
• Phase: N/A
• Start date: October 3, 2023
• Est. completion date: April 9, 2024

Study information

• Verified date: April 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 9, 2024
• Est. primary completion date: April 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage root coverage	Measured as change in percentage root coverage	Baseline to 12 months
Primary	Keratinized tissue width	Measured as change in keratinized tissue width	Baseline to 12 months