Changes of Soft Tissue Grafting: A Randomized Study

Not Applicable

Recruiting

• Conditions: Gingival Recession
• Interventions: Procedure: Split Mouth Design

• Registration Number: NCT05633511
• Lead Sponsor: Tufts University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-21
• Study First Posted: 2022-12-01
• Study Start: 2023-01-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2035-12-30
• Study Completion: 2036-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Participants	Split Mouth Design	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.

Primary Outcome Measures

Name	Time	Method
Compare autologous PRF & Autogenous CTG	5 years	Primary objective of this study is to compare in a split-mouth study the effectiveness of CTG vs. PRF in soft tissue augmentation and volume stability of each treatment modality in correcting the Cairo Class I, II defects in Periodontally affected patients

Trial Locations

Locations (1)

Tufts University School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States