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

Primary Purpose

Gingival Recession

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Non- Pedicled Buccal Fat Pad with Coronally Advanced flap

sub-epithelial connective tissue graft

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring buccal fat pad graft, sub-epithelial connective tissue graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

subepithelial connective tissue graft

non pedicled buccal fat pad graft

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Post-operative pain

Visual Analogue Scale (VAS) with numbers from 0 to 100 ('no pain' to 'worst pain

Full Information

NCT ID

NCT03543163

First Posted

May 19, 2018

Last Updated

October 12, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03543163

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2021 (Anticipated)

Primary Completion Date

March 1, 2024 (Anticipated)

Study Completion Date

June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession

Keywords

buccal fat pad graft, sub-epithelial connective tissue graft

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Blinding of the participants is not applicable. Blinding of the operator is not applicable. Outcome assessor (primary and secondary outcomes) & biostatistician will be blinded.

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

subepithelial connective tissue graft

Arm Type

Active Comparator

Arm Description

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

Arm Title

non pedicled buccal fat pad graft

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Non- Pedicled Buccal Fat Pad with Coronally Advanced flap

Intervention Description

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

Intervention Name(s)

sub-epithelial connective tissue graft

Intervention Description

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

Primary Outcome Measure Information:

Title

Recession Depth

Description

Measured from the CEJ to the most apical extension of the gingival margin using the UNC-15 periodontal probe and measured in mm unit

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Thickness of keratinized tissue

Description

Time Frame

6 months

Title

Post-operative pain

Description

Visual Analogue Scale (VAS) with numbers from 0 to 100 ('no pain' to 'worst pain

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

alia emad

Phone

01123155050

aliaemad6@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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