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

NCT03543163 | Unknown

• 1 other identifier: CEBD-CU-2018-05-15
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Keywords

buccal fat pad graft; sub-epithelial connective tissue graft

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Thickness of keratinized tissue

  6 months

• Post-operative pain

  2 weeks

Study Arms (2)

subepithelial connective tissue graft

ACTIVE COMPARATOR

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

Procedure: sub-epithelial connective tissue graft

non pedicled buccal fat pad graft

EXPERIMENTAL

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

Interventions

Non- Pedicled Buccal Fat Pad with Coronally Advanced flap 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

non pedicled buccal fat pad graft

sub-epithelial connective tissue graft PROCEDURE

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

subepithelial connective tissue graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are systemically healthy based on questionnaire dental modification of Cornell index.
• Patients are periodontally healthy with no contraindication for periodontal surgery.
• All patients are not using any kind of medications that could interfere with the health of gingiva or periodontal tissues.
• 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)
• Buccal recession defects are classified as Miller Class I or II.
• Presence of identifiable CEJ.
• The papilla fill the interdental spaces as far as the contact area
• Clinical indication and/or patient request for recession coverage.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Central Study Contacts

alia emad

CONTACT

01123155050; aliaemad6@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: * Blinding of the participants is not applicable. * Blinding of the operator is not applicable. * Outcome assessor (primary and secondary outcomes) \& biostatistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate lecturer

Study Record Dates

• First Submitted: May 19, 2018
• First Posted: June 1, 2018
• Study Start: September 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2025
• Last Updated: October 15, 2019

Record last verified: 2019-10