Effect of Connective Tissue Graft Position

November 26, 2019 updated by: Mustafa Ozcan, Cukurova University

The Effects of Connective Tissue Graft Position on Clinical and Aesthetical Outcomes of Gingival Recession Treatment. A Controlled Randomized Clinical Trial

Aim: The aim of this study was to compare the root coverage and aesthetic results of CAF+ CTG positioned apical to the CEJ (CAF+CTG-ACEJ) with CAF+CTG positioned on the CEJ (CAF+CTG-CEJ) for treating isolated gingival recession defects.

Methods: Thirthy-eight patients with Miller class I and II gingival recessions were enrolled. 19 patients were randomly assigned to the CAF+CTG-ACEJ group or CAF+CTG-CEJ group. Clinical and aesthetical evaluations were made at 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

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
      • Adana, Turkey
        • Cukurova university Faculty of Dentistry

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

19 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 19 years of age,

    • Periodontally and systemically healthy,
    • FMPS and FMBS <15%,
    • Presence of Miller Class I/II GR defect (≥3 mm in depth) at the buccal aspect of incisors and canines,
    • Presence of identifiable CEJ (step ≤1 mm at CEJ level and/or presence of a root irregularity/abrasion with identifiable CEJ, was accepted),
    • No previous periodontal surgery.

Exclusion Criteria:

  • Smoking,
  • Contraindications for surgery,
  • Presence of recession defects associated with caries, deep abrasion, restoration or pulpal pathology.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAF+ CTG positioned apical to the CEJ
Connective tissue graft covered by a coronally advanced flap which CTG apical of the CEJ level
Procedure: Coronally advanced flap + connective tissue graft
connective tissue graft covered by a coronally advanced flap with connective tissue graft apical of the cementoenamel junction level
Other: CAF+CTG positioned on the CEJ
Connective tissue graft covered by a coronally advanced flap which CTG on the CEJ level
Procedure: Coronally advanced flap + connective tissue graft
connective tissue graft covered by a coronally advanced flap with connective tissue graft apical of the cementoenamel junction level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival Recession depth in millimeters
Time Frame: 6 months
measured from the cemento-enamel junction to the gingival margin
6 months
keratinized tissue height in millimeters
Time Frame: 6 months
measured from the mucogingival junction to the gingival margin
6 months
aesthetic evaluation assesed by visual analog scale
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Cukurova University

Investigators

  • Principal Investigator: Onur Ucak Turer, PhD, Professor

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)

March 1, 2018

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

November 26, 2019

First Posted (Actual)

December 2, 2019

Study Record Updates

Last Update Posted (Actual)

December 2, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CukurovaU-PER-I

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.

Clinical Trials on Gingival Recession

Clinical Trials on Coronally advanced flap + connective tissue graft

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe