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Active, Not Recruiting

NCT Number: NCT07521566

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extraoral de-epithelialization Group

Procedure

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

Radiofrequency De-epithelialization

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Acronym: DEEP-RCT

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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