Changes of Soft Tissue Grafting: A Randomized Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-11

Study Completion Date

2036-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gingival Recession

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All Participants

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.

Group Type EXPERIMENTAL

Split Mouth Design

Intervention Type PROCEDURE

PRF on one side of mouth and CTG on the other side of participant's mouth.

Interventions

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Split Mouth Design

PRF on one side of mouth and CTG on the other side of participant's mouth.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No