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

Not Applicable

Not yet recruiting

• Conditions: Gingival Recession
• Interventions: Procedure: Non- Pedicled Buccal Fat Pad with Coronally Advanced flap; Procedure: sub-epithelial connective tissue graft

• Registration Number: NCT03543163
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-19
• Study First Submitted QC: 2018-05-31
• Study First Posted: 2018-06-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-12
• Last Update Posted: 2019-10-15
• Study Start: 2021-09-01
• Primary Completion: 2024-03-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non pedicled buccal fat pad graft	Non- Pedicled Buccal Fat Pad with Coronally Advanced flap	Non- Pedicled Buccal Fat Pad with Coronally Advanced flap at the site of gingival recession
subepithelial connective tissue graft	sub-epithelial connective tissue graft	Subepithelial Connective Tissue graft from the hard palate with Coronally Advanced flap at the site of gingival recession.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Thickness of keratinized tissue	6 months	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
Post-operative pain	2 weeks	Visual Analogue Scale (VAS) with numbers from 0 to 100 ('no pain' to 'worst pain