Comparison of Different De-epithelialization Techniques of Soft Tissue Grafts.

NCT05494294 | Completed

• 1 other identifier: quality of graft
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized comparative controlled clinical trial, 50 patients with single recession defects with thin phenotype were treated with coronally advanced flap. The connective tissue graft was obtained by removing the keratinized layer of the tissue. Removal of the epithelium was achieved by to different approach. At first group epithelium and remnants were removed extraorally whereas others were intraorally. After the removal, obtained graft laid on a lamella, and residual keratinocytes were observed under the microscope. Amount of recession reduction recorded at the 6th week, 6th month, 12th month, and keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level, were also evaluated. Keratinized tissue change, Gingival thickness change, root coverage, clinical attachment gain, and complete root coverage were calculated. Wound healing index, tissue appearance, patient expectations, aesthetics, and dentine hypersensitivity were assessed at baseline and 6th week.

Conditions

Connective Tissue Graft Harvesting

Outcome Measures

Primary Outcomes (3)

• Recession reduction

  RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.

  3rd month

• Recession reduction

  RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.

  6th month

• Recession reduction

  RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.

  12th month

Secondary Outcomes (45)

• amount of deciduous cells

  at the day of the surgery.

• percentage of deciduous cells

  at the day of the surgery

• Recession Depth (RD)

  Baseline.

• Recession Depth (RD)

  3rd month

• Recession Depth (RD)

  6th month

Study Arms (2)

Intraoral

ACTIVE COMPARATOR

In this group, the grafts were de-epithelialized at the donor site before harvesting. The calibrated surgeon removed the epithelium with a sharp Kirkland knife under magnification. To be sure of the elimination whole epithelial layer, bleeding was observed. Recipient site was prepared as follows; A after sulculer incision had done (blade 15c) two vertical incions were made from the gingival margin to 3 mm beyond the mucogingival junction A partial-thickness flap was elevated under the recession area and full thickness flap elevated adjacent flap portions. then relasing incisions were made apically from the mucogingival junction. After the preparation of the recipient site, obtained graft was sutured 1 mm apically to the cemento-enamel junction. Finally flap was positioned without tension and stabilized at least 2mm coronally from the cemento-enamel margin with the single interrupted sutures.

Procedure: Intraorally de-epithelialization

Extraoral

ACTIVE COMPARATOR

In this group, the grafts were de-epithelialized after graft harvesting. The calibrated surgeon removed the epithelium with 15 c knife under magnification. all remnants were removed under magnification. Same recipient site procedure was conducted in this group.

Procedure: Extraorally de-epithelialization

Interventions

Intraorally de-epithelialization PROCEDURE

In this group, the grafts were de-epithelialized at the donor site before harvesting. The calibrated surgeon removed the epithelium with a sharp Kirkland knife under magnification. To be sure of the elimination whole epithelial layer, bleeding was observed. Recipient site was prepared as follows; A after sulculer incision had done (blade 15c) two vertical incions were made from the gingival margin to 3 mm beyond the mucogingival junction A partial-thickness flap was elevated under the recession area and full thickness flap elevated adjacent flap portions. then relasing incisions were made apically from the mucogingival junction. After the preparation of the recipient site, obtained graft was sutured 1 mm apically to the cemento-enamel junction. Finally flap was positioned without tension and stabilized at least 2mm coronally from the cemento-enamel margin with the single interrupted sutures.

Intraoral

Extraorally de-epithelialization PROCEDURE

In this group, the grafts were de-epithelialized after graft harvesting. The calibrated surgeon removed the epithelium with 15 c knife under magnification. all remnants were removed under magnification. Same recipient site procedure was conducted in this group.

Extraoral

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Single tooth recession more than 2mm
• Gingival thickness less than 1mm

You may not qualify if:

• unstable endodontic conditions or presence of any restoration/abrasion,
• tooth mobility, any surgical history or gingival enlargement in the area,
• smoking
• uncontrolled systemic disease, pregnancy or use of drugs known to affect gingival conditions

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• Din F, Kabalak MO, Yilmaz BT, Baris E, Avci H, Caglayan F, Keceli HG. Efficacy of different gingival graft de-epithelialization methods: A parallel-group randomized clinical trial. Clin Oral Investig. 2025 May 7;29(6):289. doi: 10.1007/s00784-025-06365-7.

  PMID: 40332625 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients were randomly assigned into intraorally de-epithelialization group (n=25) and extraorally de-epithelialization group (n=25) groups by one of the authors with an allocation ratio of 1:1 using a computer-generated program after successful completion of the phase I periodontal treatment. One calibrated author masked the applied surgical technique and recorded all clinical variables. The surgeon opened the labeled envelope containing the intervention name.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 9, 2022
• Study Start: July 4, 2021
• Primary Completion: July 30, 2022
• Study Completion: August 5, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Locations

TU (1)