Comparative Evaluation of Buccal Fat Pad and Subepithelial Connective Tissue Graft (RCT)

January 30, 2022 updated by: shehad wael, Ain Shams University

Comparative Evaluation of Buccal Fat Pad and Subepithelial Connective Tissue Graft in the Treatment of Localized Recession (Randomized Clinical Trial)

Compare between Buccal fat pad and subepithelial connective tissue graft in treatment of localized recession.

Primary objective: to evaluate root coverage in terms of gingival thickness and esthetic.

Secondary objective: to evaluate patient satisfaction and postoperative pain.

Study Overview

Status

Completed

Conditions

Detailed Description

Material and Methods

16 patients from outpatient Oral Diagnosis dental clinic will participate in this study.

Patient selection and hospitalization

Prospective randomized clinical trial will be conducted on patients requiring correction of gingival recession. The research will be reviewed by the ethical committee of Faculty of Dentistry Ain Shams University.

Patient Grouping

Patient will be randomly allocated into one of the two groups:

control group (8 patients): will be treated with coronally advanced flap combined with subepithelial Connective tissue graft (SCTG).

Study group(8 patients): will be treated with coronally advanced flap combined with buccal fat pad (BFP).

Preoperative Assessment

For all patients routine radiographic investigations are required. The first phase of therapy formed of oral hygiene measures, scaling, subgingival debridement and correction of any disturbance in occlusion needed. A periodontal evaluation should be done two weeks after phase I therapy.

A stent will be made for each defect with vertical groove located at the mid-labial region to standardize the placement and angulation of probe while taking measurement. All measurements will be taken with a standardized Williams graduated periodontal probe (Hu-Friedy).

Surgical procedure:

  • Oral antiseptic mouthwash will be used before anaesthetizing the surgical area. A field block anesthesia at the surgical area is given with a lidocaine and epinephrine-containing solution.

    a) Recipient site preparation

  • A split-thickness flap will be reflected by a horizontal incision made at the papilla base, mesial and distal to the recession defects. Two slightly divergent incisions will be released from the end of the previous horizontal incisions with a full-thickness flap starting from margin of the gingiva reaching 3-4 mm after the exposed bone then continue with a split-thickness extending to the alveolar mucosa .
  • After flap elevation scaling, planing of the exposed root followed by root conditioning with a tetracycline solution (125 mg tetracycline/ml of saline). In the study group sites, previously prepared BFP or a subepihelial CT graft in control group will be applied over the exposed root a single sling suture will fix the flap just coronal to the Cemento-enamel junction (CEJ). Flaps will also be coronally positioned.

    b) Donor site:

  • In study group the buccal vestibule is anesthetized in vicinity of the first and second maxillary molar. The cheek will be retracted laterally and a mucosal incision will be made while leaving a cuff of non- attached mucosa for closure. The incision will be done throughout the mucosa and muscle meanwhile an external pressure will be applied on the skin in the area of the buccal fat pad. After the buccal fat pad exposure, the fascia is pierced with scissors. With a continuous external pressure on the cheeck a long hemostat is used to spread and manipulate the fat. With minimal delicate traction, the protruding portion of the fat pad is gently grasped and pulled outside of the incision then the fat is clamped at the base and the required amount is harvested and excised to be used in donor site. The incision is closed with suture .
  • The control group will receive SCTG from the palate with a single incision technique .

Postoperatively patients will be covered by Augmentine 1 gm tablets every 12 hours and flagyl 500 mg every eight hours. Analgesics are given in a combined protocol; where ibuprofen 600mg and paracetamol 1gm are alternating. The patient is instructed to use 0.12% chlorhexidine mouthwash three times daily for two weeks.

Methods of assessment

The parameters which should be measured at baseline, 3 and 6 months after surgery:

  1. Plaque index (PI) will be recorded according to Silness and Loe .
  2. Gingival index (GI) will be recorded according to Loe and Silness .
  3. Probing depth (PD).
  4. Clinical attachment level (CAL).
  5. Recession depth (RD).
  6. Recession width (RW).
  7. Percentage of mean root coverage (MRC %) will be calculated as ([RD preoperative - RD postoperative]/RD preoperative) × 100%.
  8. Width of keratinized tissue (WKT).
  9. Gingival thickness (GTH).
  10. Root coverage esthetic score (RES).
  11. Pain level will be assessed by verbal, numeric scale and by recording amount of analgesic intake postoperatively.

Result presentation and statistics

Results will be tabulated and statistically analyzed.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt, 11757
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients should be above 18 years.
  • Patient included in the study will be with Miller class II recession defect.
  • Patient having at least 1 mm of residual keratinized tissue.

Exclusion Criteria:

  • Patient with Systemic Problem affecting the results of periodontal Therapy.
  • Patients having allergy to drugs.
  • Pregnant women.
  • Patients with any smoking habits.
  • Patients having bleeding problems or on anticoagulant therapy.
  • Patients having caries or restorations in relation to the treated site.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
Use of free fat graft to cover exposed root
fat harvested from patient will be used to cover exposed root
Active Comparator: control group
use of sub epithelial connective tissue graft to cover exposed root
subepitheial graft harvested from palate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of root coverage esthetic score
Time Frame: 6 months
evaluation of root gingival coverage after modified Coronally advanced flap the scale is from 1-4 ... based on degree of coverage the score will be given 1=1005, 2=75%, 3=50%, 4=25%
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: shehad wael, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2018

Primary Completion (Actual)

January 24, 2021

Study Completion (Actual)

January 24, 2021

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

April 16, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

January 30, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gingival Recession

Clinical Trials on free fat graft

Subscribe