Histological and Clinical Evaluation of De-epithelialized Connective Tissue Grafts Obtained by Different Methods

NCT07521566 | Active Not Recruiting

• 1 other identifier: 691-SBAAEK
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingival Recessions; Gingival Recession, Mucogingival Surgery

Keywords

gingival recession; connective tissue graft; radiofrequency

Outcome Measures

Primary Outcomes (2)

• Presence of Epithelial Remnants

  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

  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

Study Arms (2)

Extraoral de-epithelialization Group

EXPERIMENTAL

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

Radiofrequency De-epithelialization Group

EXPERIMENTAL

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

Interventions

Extraoral de-epithelialization Group PROCEDURE

Extraoral de-epithelialization of connective tissue grafts using a scalpel prior to graft placement.

Extraoral de-epithelialization Group

Radiofrequency De-epithelialization PROCEDURE

Intraoral de-epithelialization of connective tissue grafts using a radiofrequency device prior to graft placement.

Radiofrequency De-epithelialization Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Location

Related Publications (3)

• Ozcelik O, Seydaoglu G, Haytac CM. Diode laser for harvesting de-epithelialized palatal graft in the treatment of gingival recession defects: a randomized clinical trial. J Clin Periodontol. 2016 Jan;43(1):63-71. doi: 10.1111/jcpe.12487. Epub 2016 Jan 21.

  PMID: 26660000 RESULT

• Couso-Queiruga E, Gonzalez-Martin O, Stuhr S, Gamborena I, Chambrone L, Avila-Ortiz G. Comparative histological evaluation of intra- and extraorally de-epithelialized connective tissue graft samples harvested from the posterior palate region. J Periodontol. 2023 May;94(5):652-660. doi: 10.1002/JPER.22-0493. Epub 2023 Jan 30.

  PMID: 36582071 RESULT

• Azar EL, Rojas MA, Mandalunis P, Gualtieri A, Carranza N. Histological evaluation of subepithelial connective tissue grafts harvested by two different techniques: Preliminary study in humans. Acta Odontol Latinoam. 2019 Apr 1;32(1):10-16.

  PMID: 31206569 RESULT

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor was blinded to the group allocation to minimize assessment bias. Due to the nature of the surgical procedures, participants and care providers were not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Principal Investigator and Periodontologist

Model Details: Two parallel groups were included in this randomized controlled clinical trial. Participants were randomly assigned to receive de-epithelialized connective tissue grafts prepared using either an extraoral scalpel technique or an intraoral radiofrequency (RF) device. All interventions were performed in combination with coronally advanced flap surgery for the treatment of gingival recession defects.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 13, 2026
• Study Start: September 19, 2025
• Primary Completion: October 6, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

TU (1)