NCT07521566

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Dokuz Eylul University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Gingival Recessions
• Gingival Recession, Mucogingival Surgery

Interventions

Type	Name	Description
PROCEDURE	Extraoral de-epithelialization Group	Extraoral de-epithelialization of connective tissue grafts using a scalpel prior to graft placement.
PROCEDURE	Radiofrequency De-epithelialization	Intraoral de-epithelialization of connective tissue grafts using a radiofrequency device prior to graft placement.

Timeline

• Start date: 2025-09-19
• Primary completion: 2025-10-06
• Completion: 2026-06-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Turkey (Türkiye)