Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions

August 12, 2024 updated by: Ezgi Gürbüz, Kutahya Health Sciences University

Clinical Comparison of Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions

The primary purpose of this study is to compare the root coverage rate of the gingival unit-shaped connective tissue graft, obtained by intraoral de-epithelization, with the traditional de-epithelialized free gingival graft in localized recessions of anterior and premolar teeth. In addition, it is aimed to compare the postoperative gingival thickness between the two techniques. The secondary aim is to search the effects of both techniques on periodontal parameters and to evaluate patient-centered outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

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
      • Kutahya, Turkey, 43020
        • Kütahya Health Sciences 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. American Society of Anesthesiologists physical status class 1 and 2 patients,healthy patients
  2. Nonsmokers
  3. Periodontally healthy patients
  4. Localized gingival recessions (Miller I, II, and Cairo I recessions with a depth of recession of at least 2 mm) in anterior and premolar teeth

Exclusion Criteria:

  1. Medically compromised patients, especially uncontrolled diabetes
  2. Pregnancy, lactation, or suspicion of pregnancy,
  3. Poor oral hygiene
  4. Recessions associated with caries or restoration

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: De-epithelialized gingival unit graft
In this split-mouth randomized controlled trial, the coin toss method will determine test and control groups. In both groups, connective tissue graft with a trapezoidal flap design will be applied to the recession area. To obtain the connective tissue graft, the gingival unit graft will be de-epithelialized in the test group.
Procedure: Coronally advanced flap with connective tissue graft
In both groups, connective tissue graft with a trapezoidal flap design will be applied to the recession area.
Experimental: De-epithelialized free gingival graft
In this split-mouth randomized controlled trial, the coin toss method will determine test and control groups. In both groups, connective tissue graft with a trapezoidal flap design will be applied to the recession area. To obtain the connective tissue graft, the traditional free gingival graft will be de-epithelialized in the control group.
Procedure: Coronally advanced flap with connective tissue graft
In both groups, connective tissue graft with a trapezoidal flap design will be applied to the recession area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Root coverage percentage
Time Frame: Postoperative 6th month
The comparison of the postoperative recession depth to the initial recession depth
Postoperative 6th month
Gingival thickness
Time Frame: Preoperative and postoperative 6th month
Gingival thickness in the mid-buccal of the recession defect measured with an endodontic spreader and digital recordings
Preoperative and postoperative 6th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recession width
Time Frame: Preoperative and postoperative 6th month
Recession width measured at the cemento-enamel junction
Preoperative and postoperative 6th month
Probing depth
Time Frame: Preoperative and postoperative 6th month
Probing depth measured at the mid-buccal of the recession defect
Preoperative and postoperative 6th month
Clinical attachment loss
Time Frame: Preoperative and postoperative 6th month
Clinical attachment loss measured at the mid-buccal of the recession defect
Preoperative and postoperative 6th month
Keratinized gingiva width
Time Frame: Preoperative and postoperative 6th month
Mid-buccal gingival width measured with a periodontal probe
Preoperative and postoperative 6th month
Vestibular depth
Time Frame: Preoperative and postoperative 6th month
The distance from the gingival margin to the greatest concavity of the mucosal fold
Preoperative and postoperative 6th month
Bleeding related to the procedure
Time Frame: Postoperative 1st week
Bleeding evaluated by a dichotomous index
Postoperative 1st week
Pain perception
Time Frame: Postoperative 1st week
Visual analog scale where higher scores mean a worse outcome and has a minimum value of 0 and a maximum value of 10
Postoperative 1st week

Collaborators and Investigators

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

Sponsor

Kutahya Health Sciences 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)

August 10, 2023

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

July 3, 2024

Study Registration Dates

First Submitted

June 20, 2023

First Submitted That Met QC Criteria

June 20, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0043

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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