Tunneling Technique in Treatment of Miller's Class III Gingival Recession

September 4, 2018 updated by: Nourhan Abdallah Abdelkhalek, Cairo University

Analysis of the Aesthetic Outcome After Root Coverage Using Tunneling Technique With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Modified Free Gingival Graft in Miller's Class III Recession Defect: a Randomized Clinical Trial

Several surgical techniques have been proposed to correct recession defect and attain root coverage. Though, the majority were executed on Miller Class I and II recession defects. Moreover, Analysis of literature revealed only a few studies that treated miller class III recession defects.

In the current study, a new modification in the free gingival graft is proposed to provide the patient with more esthetic outcome, less pain and postoperative trauma. Likewise, the proposed graft modification will combined both FGG and CTG benefits, overcome the limitations of the FGG and enhances the advantages of CTG.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In the current study, patients with Miller's class III will be randomly allocated in two groups. In the first group, gingival recession will be treated by tunneling technique with subepithelial connective tissue graft (sCTG). the tunnel preparation will be performed in the recession site then the sCTG will be harvested from the palate and inserted in the prepared tunnel and sutured in a coronally advanced position.

Equally , the second group will be treated with modified free gingival graft (mFGG). Initially, after tunnel preparation in the recession site and harvesting of the free gingival graft,the proposed modification is performed by mimicking the recession defect shape and size leaving the rest of the free gingival graft deepithelialized and inserted in the prepared tunnel. then, suturing will be performed in a coronally advanced position.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with healthy systemic condition.
  2. Buccal recession defects classified as Miller class III.
  3. Clinical indication and/or patient request for recession coverage.
  4. O'Leary index less than 20%.

Exclusion Criteria:

  1. Pregnant females.
  2. Smokers as smoking is a contraindication for any plastic periodontal surgery.
  3. Unmotivated, uncooperative patients with poor oral hygiene
  4. Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A
tunnel procedure with subepithelial connective tissue graft (sCTG)
Procedure: group A (Tunnel procedure with subepithelial connective tissue graft (sCTG)
Subepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the prepared tunnel to treating gingival recession
Other Names:
  • Tunnel procedure with subepithelial connective tissue graft (sCTG)
  • Autogenous sCTG will be used with tunnel procedure
Active Comparator: group B
tunnel procedure with modified free gingival graft (mFGG)
Procedure: group B (Tunnel procedure with modified free gingival graft (mFGG))
modified free gingival graft (autogenous graft) will be harvested from the palate and will be used with the prepared tunnel to be used in treating gingival recession
Other Names:
  • Tunnel procedure with modified free gingival graft (mFGG)
  • Autogenous mFGG will be used with tunnel procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
root coverage aesthetic score (RES)
Time Frame: 6 months

RES evaluated five variables 6 months: gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC). Zero, 3, or 6 points were used for the evaluation of the position of the gingival margin, whereas a score of 0 or 1 point was used for each of the other variables.

The ideal esthetic score was 10. Zero points were assigned if the final position of the gingival margin was equal or apical to the previous recession depth (failure of root coverage procedure), irrespective of color, the presence of a scar, MTC, or MGJ. Zero points were also assigned when a partial or total loss of interproximal papilla (black triangle) occurred following the treatment
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recession depth
Time Frame: 6 months
Measured from the cemento-enamel junction the most apical extension of the gingival margin.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2018

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

June 26, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2018-06-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

all the study records may be shared except that include participant name or personal information identifiers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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