Histological and Clinical Evaluation of De-epithelialized Connective Tissue Grafts Obtained by Different Methods (DEEP-RCT)

April 8, 2026 updated by: Ayça Muhterem, Dokuz Eylul University
This randomized controlled clinical study aimed to evaluate the effectiveness of two different de-epithelialization techniques-extraoral scalpel and intraoral radiofrequency (RF)-used in the preparation of de-epithelialized connective tissue grafts (De-CTG) for the treatment of gingival recession. A total of 48 patients were randomly assigned into two groups, and all grafts were applied in combination with coronally advanced flap (CAF) surgery. Clinical and histological outcomes, including epithelial remnants, root coverage, keratinized tissue gain, surgical duration, and postoperative patient comfort, were assessed. The study seeks to identify a reliable, operator-independent method that minimizes epithelial remnants and improves clinical outcomes and patient experience.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Gingival recession, defined as the apical displacement of the gingival margin relative to the cementoenamel junction, is a common clinical condition associated with both functional and esthetic concerns. Subepithelial connective tissue grafts (SCTG) combined with coronally advanced flap (CAF) procedures are widely regarded as the gold standard for root coverage, particularly in patients with thin gingival phenotypes. However, SCTGs may contain undesirable components such as adipose tissue, glandular structures, and neural elements, which can negatively affect graft integration and healing.

To overcome these limitations, de-epithelialized connective tissue grafts (De-CTGs) have been introduced as an alternative, offering a more homogeneous connective tissue composition. Despite their advantages, one of the major challenges associated with De-CTGs is the potential presence of residual epithelial remnants, which may impair healing and compromise clinical outcomes.

Various de-epithelialization techniques have been proposed, including the use of scalpels, burs, lasers, and more recently, radiofrequency (RF) devices. RF technology operates at ultra-high frequencies (3-4 MHz) and has been associated with minimal thermal damage, reduced tissue trauma, faster healing, and improved postoperative comfort compared to conventional methods. However, its application as a de-epithelialization technique in connective tissue graft harvesting for gingival recession treatment has not been previously investigated.

The present study was designed as a randomized controlled clinical trial involving 48 patients with gingival recession defects. Participants were randomly allocated into two groups: in the first group, De-CTGs were prepared using an extraoral scalpel technique, while in the second group, de-epithelialization was performed intraorally using an RF device. All grafts were used in conjunction with CAF surgery.

The outcomes of the study were evaluated through both clinical and histological parameters. Clinical assessments included root coverage, keratinized tissue width gain, probing depth, and clinical attachment level. Histological analysis focused on the presence or absence of epithelial remnants within the grafts. Additionally, surgical time and postoperative patient-reported outcomes, such as pain and discomfort, were recorded to assess patient-centered benefits.

The primary objective of this study is to determine an optimal de-epithelialization technique that ensures complete removal of epithelial remnants, provides ease of manipulation regardless of clinician experience, and enhances both clinical success and patient comfort. Furthermore, the study aims to explore the feasibility of RF as a practical, cost-effective, and minimally invasive alternative for graft preparation in periodontal plastic surgery.

Study Type

Interventional

Enrollment (Estimated)

48

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

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:

  • Voluntary individuals aged between 18 and 80 years
  • Systemically healthy
  • Non-smokers
  • Patients diagnosed with periodontal health following Phase I therapy, with reduced periodontium both clinically and radiographically
  • Presence of Cairo RT I and RT II gingival recession defects involving maxillary and mandibular anterior and premolar teeth
  • Presence of at least 1 mm of keratinized gingiva
  • Individuals not using any medications that may affect periodontal tissue health or wound healing
  • Absence of any pathology in the palatal mucosa that may interfere with the surgical procedure for connective tissue harvesting

Exclusion Criteria:

  • Teeth with caries, non-carious cervical lesions, or restorations in the gingival recession area
  • Teeth with endodontic pathology
  • Pregnant or lactating women
  • Patients with cardiac pacemakers
  • Teeth where the cementoenamel junction cannot be clearly identified
  • Individuals for whom the use of a radiofrequency device may pose a risk
  • Use of antibiotics or immunosuppressive medications within the last 3 months

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
Experimental: Extraoral de-epithelialization Group
Participants received de-epithelialized connective tissue grafts prepared using an extraoral scalpel technique in combination with coronally advanced flap surgery for the treatment of gingival recession defects.
Procedure: Extraoral de-epithelialization Group
Extraoral de-epithelialization of connective tissue grafts using a scalpel prior to graft placement.
Experimental: Radiofrequency De-epithelialization Group
Participants received de-epithelialized connective tissue grafts prepared using an intraoral radiofrequency (RF) device in combination with coronally advanced flap surgery for the treatment of gingival recession defects.
Procedure: Radiofrequency De-epithelialization
Intraoral de-epithelialization of connective tissue grafts using a radiofrequency device prior to graft placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Epithelial Remnants
Time Frame: At the time of surgery
Histological evaluation of harvested grafts to determine the presence or absence of epithelial remnants after de-epithelialization using scalpel or radiofrequency methods.
At the time of surgery
Complete Root Coverage
Time Frame: 3-6 months
The percentage of gingival recession defects achieving complete root coverage following treatment with de-epithelialized connective tissue grafts prepared using either scalpel or radiofrequency techniques in combination with coronally advanced flap surgery.
3-6 months

Collaborators and Investigators

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

Sponsor

Dokuz Eylul 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)

September 19, 2025

Primary Completion (Actual)

October 6, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 691-SBAAEK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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