Changes of Soft Tissue Grafting: A Randomized Study

Tufts University

Status: Enrolling

Conditions: Gingival Recession

Treatments: Procedure: Split Mouth Design

Study type: Interventional

Funder types: Other

Identifiers

NCT05633511

STUDY00003133

Details and patient eligibility

About

To correct gum recession, patient's own tissue from the roof of the mouth is harvested and placed where there is root exposed. This is considered gold standard of treatment. Sometimes patient don't want to have second surgical site in their mouth and at the same time do not want to use alternative tissue from human or animal donor. Using patients' blood and preparing it as a membrane is the next best thing to correct gum recession.

Full description

Patients that are interested in having corrective surgery for recession due to esthetic concerns or sensitivity will be enrolled in the study. The treatment site will randomly receive the procedure assignment. Intraoral scanner will be utilized to establish pre-op volume and will be repeated at each follow up visit. Total of 12 visits and 5 year duration is anticipated for the study.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults 18yrs or older
2. Need of MG-tx for 2 or more sites for root coverage RT I and II (Cairo classification)
3. Class A +/-
4. No class V restoration present

Exclusion criteria

1. Patients who do not consent to recommended therapy
2. Patients who smoke
3. Patients who will not be able to comply with follow up protocols
4. Those who self report that they are pregnant.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

All Participants

Experimental group

Description:

Participants will receive the CTG procedure on one side and the PRF procedure on the other. Both are standard of care soft tissue grafting methods and a split mouth design is standard of care.

Treatment:

Procedure: Split Mouth Design