Treatment of Miller Class I and II Gingival Recession Using Non- Pedicled Buccal Fat Pad Graft as Compared to Subepithelial Connective Tissue Graft

The Evaluation of Recession Depth After Treating Miller Class I and II Gingival Recession Using Non- Pedicled Buccal Fat Pad Graft as Compared to Subepithelial Connective Tissue Graft. A Randomized Controlled Clinical Trial

This randomized controlled single blinded parallel clinical trial is held to monitor if the use of the non pedicled buccal fat pad graft will result in post operative pain as a primary outcome compared to that occurs with the use of the sub epithelial connective tissue graft in treating Miller Class I and Class II gingival recession

Study Overview

• Status: Not yet recruiting
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: sub-epithelial connective tissue graft; Procedure: Non- Pedicled Buccal Fat Pad with Coronally Advanced flap

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: alia emad; Phone Number: 01123155050; Email: aliaemad6@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients are systemically healthy based on questionnaire dental modification of Cornell index.
2. Patients are periodontally healthy with no contraindication for periodontal surgery.
3. All patients are not using any kind of medications that could interfere with the health of gingiva or periodontal tissues.
4. O'Leary index is less than 10% ( the surgical therapy is not initiated until the patient reaches the 10% level or less of plaque accumulation)
5. Buccal recession defects are classified as Miller Class I or II.
6. Presence of identifiable CEJ.
7. The papilla fill the interdental spaces as far as the contact area
8. Clinical indication and/or patient request for recession coverage.

Exclusion Criteria:

1. Miller Class III or IV recession defects
2. Pregnant female.
3. Smokers as smoking is contraindicated for any plastic periodontal surgery
4. Patients with special needs or with any mental problems.
5. Patients undergoing radiotherapy
6. Teeth with carious or non-carious lesion or cervical restorations
7. Rotated teeth and tooth extrusion with or without occlusal abrasion
8. Patient undergone any prior periodontal surgery in the relevant region.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: subepithelial connective tissue graft; Subepithelial Connective Tissue graft from the hard palate with Coronally Advanced flap at the site of gingival recession.	Procedure: sub-epithelial connective tissue graft; a sub- epithelial connective tissue graft is harvested from the hard palate is used to treat area with gingival recession
Experimental: non pedicled buccal fat pad graft; Non- Pedicled Buccal Fat Pad with Coronally Advanced flap at the site of gingival recession	Procedure: Non- Pedicled Buccal Fat Pad with Coronally Advanced flap; A horizontal incision of 1.5cm in long will be made at the bottom of the vestibule with the #15 blade in the region of maxillary first and second molars, depending on side of the recipient site. A curved hemostat will be used in the blunt dissection through the buccinators muscle to temporarily reposition and loose the surrounding fascia which will allow the buccal fat pad to be exposed in the oral cavity. A portion of adipose tissue equals to the required graft size will be excised with the microsurgical scissors. The grafting material will be placed on a saline-soaked gauze until its transfer to the recipient site. Finally, the patient's check will be compressed, in order to promote the closure of the wound edges then immediately close the donor site with simple 5.0 silk thread interrupted sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recession Depth	Measured from the CEJ to the most apical extension of the gingival margin using the UNC-15 periodontal probe and measured in mm unit	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thickness of keratinized tissue	Evaluation of the gingival thickness by trans-gingival piercing using an anesthetic needle with a silicon stopper inserted perpendicular to the mucosal surface with light pressure until touching a hard surface and the silicon disk in a tight contact with soft tissue surface. This measurement should be taken 1.5 mm apical from the gingival margin. Then the correct position of the disk is fixed with a drop of cyanoacrylic adhesive after careful removal of the needle. The penetration depth is measured by an accurate caliper	6 months
Post-operative pain	Visual Analogue Scale (VAS) with numbers from 0 to 100 ('no pain' to 'worst pain	2 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: May 19, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 12, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: buccal fat pad graft; sub-epithelial connective tissue graft
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: CEBD-CU-2018-05-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No