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

NCT ID: NCT03543163

Last Updated: 2019-10-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2025-06-01

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

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

subepithelial connective tissue graft

Subepithelial Connective Tissue graft from the hard palate with Coronally Advanced flap at the site of gingival recession.

Group Type: ACTIVE_COMPARATOR

sub-epithelial connective tissue graft

Intervention Type: PROCEDURE

a sub- epithelial connective tissue graft is harvested from the hard palate is used to treat area with gingival recession

non pedicled buccal fat pad graft

Non- Pedicled Buccal Fat Pad with Coronally Advanced flap at the site of gingival recession

Group Type: EXPERIMENTAL

Non- Pedicled Buccal Fat Pad with Coronally Advanced flap

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Alia Emad Mohammed

associate lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

alia emad

Role: CONTACT

aliaemad6@gmail.com

01123155050

Other Identifiers

CEBD-CU-2018-05-15

Identifier Type: -

Identifier Source: org_study_id