The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage

November 18, 2020 updated by: Sibel Kayaalti-Yuksek, Okan University

The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage: A Randomized Split-Mouth Clinical Trial

The purpose of the study is to compare the clinical effectiveness of gingival unit graft (GUG) and connective tissues graft (CTG) in Miller's class I and II gingival recession.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who accept the study have provided information about the study and required a written informed consent form. The clinical effectiveness of two different periodontal surgical techniques (gingival unit graft and connective tissue graft) in gingival recessions will be evaluated. Periodontal measurements (gingival recession, keratinized gingiva height) and patient-reported outcomes (intra and post-operative pain, patient satisfaction and hypersensitivity) are defined.

Study Type

Interventional

Enrollment (Actual)

16

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

  • Turkey
    • Tuzla
      • Istanbul, Tuzla, Turkey, 34852
        • Sibel Kayaaltı Yüksek

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Systemic healthy individuals
  • Presence Miller's class I and II gingival recession in the anterior and premolar teeth

Exclusion Criteria:

  • Age <18 years
  • Pregnancy
  • Lactation
  • Any cardiovascular, renal or hepatic conditions
  • History of periodontal surgery
  • Tooth mobility
  • Presence of probing depth >3 mm and caries or restorations in the teeth undergoing treatment

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gingival Unit Graft
For test group, gingival recessions were treated with gingival unit graft.
Procedure: Root coverage treatment
Gingival unit graft Connective tissue graft
Other: Connective Tissue Graft
For Control group, gingival recessions were treated with connective tissue graft.
Procedure: Root coverage treatment
Gingival unit graft Connective tissue graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Gingival Recession Depth at 6 month
Time Frame: Baseline and month 6.
The gingival recession depth consists of the distance from the cement-enamel junction to the most apical extension of the gingival margin. The measurement is recorded in millimeters. Change= (6 month score-baseline score)
Baseline and month 6.
Change from Baseline Keratinized Gingiva Height at 6 month
Time Frame: Baseline and month 6.
Keratinized gingiva height, measured as the distance from the gingival margin to the mucogingival line. The measurement is recorded in millimeters. Change= (6 month score-baseline score)
Baseline and month 6.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Root Hypersensitivity at 6 month
Time Frame: Baseline and month 6.
Root hypersensitivity at baseline and post-operative 6 month utilizing a visual numerical scale (VNS) test are defined. Possible scores range from (0=no sensitive and 10= worst possible sensitive). Change= (6 month score-baseline score)
Baseline and month 6.
Change from Baseline Patient Satisfaction at 6 month
Time Frame: Baseline and month 6.
The patient satisfaction with the gingiva position, structure and color of the gingival recessions sites utilizing a VNS test (0=not satisfied and 10=very satisfied) are defined. Possible scores range from 0 (not satisfied) to 10 (very satisfied). Change= (6 month score-baseline score)
Baseline and month 6.
Change from Baseline Pain at 1 week
Time Frame: Baseline and week 1.
Pain perception of the surgery at intra and post-operative period (week 1) utilizing a VNS test are defined. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change= (1 week score-baseline score)
Baseline and week 1.
Change from Baseline Pain at 2 week
Time Frame: Baseline and week 2.
Pain perception of the surgery at intra and post-operative period (week 2) utilizing a VNS test are defined. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change= (2 week score-baseline score)
Baseline and week 2.

Collaborators and Investigators

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

Sponsor

Okan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2015

Primary Completion (Actual)

July 15, 2016

Study Completion (Actual)

July 30, 2016

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 18, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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