Evaluation of the Clinical Efficacy of De-Epithelialized Free Gingival Graft in the Treatment of Gingival Recessions

NCT07100808 | Completed

• 1 other identifier: 17.06.2020/14
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the clinical effectiveness of three techniques used in combination with the tunnel method for the treatment of multiple gingival recessions: subepithelial connective tissue graft (SCTG Group), scalpel-de-epithelialized free gingival graft (Scalpel Group), and Erbium, Chromium: Yttrium-Scandium-Gallium-Garnet (Er,Cr:YSGG) laser-de-epithelialized free gingival graft (Laser Group).

Conditions

Gingival Recessions

Keywords

Laser Therapy; Gingival Recession; autografts

Outcome Measures

Primary Outcomes (8)

• The percentage of Root Coverage (RCP)

  In this study, the difference between the root surface coverage rate in areas with gingival recession was evaluated by subtracting the 6th month recession depth from the pre-treatment recession depth.

  Baseline and 6 months

• Clinical Attachment Level

  The distance from the mid-buccal point of the teeth to the groove/pocket base based on the cemento-enamel junction was measured in mm with a periodontal probe.

  baseline and 6th months

• Recession Depth

  The mid-buccal point of the teeth with gingival recession was measured with a periodontal probe, taking the cemento-enamel junction as the basis, until the coronal part of the gingival margin.

  baseline and 6th month

• Width of Keratinized Tissue

  Clinically, it is determined by subtracting the distance between the free gingival margin and the mucogingival line from the distance to the groove/pocket base.

  baseline and 6th month

• Transgingival Gingival Thickness

  In this study, gingival thickness was determined by the transgingival probing method.

  baseline and 6th month

• Gingival İndex

  Loe ve Silness, 1963 (0-3, skor)

  Baseline and 6th month

• Plaque Index

  Silness ve Löe, 1966

  baseline and 6th month

• Probing Depth

  Each tooth was measured from the gingival margin to the sulcus base using a periodontal Williams probe, and probing depths were recorded.

  baseline and 6th month

Secondary Outcomes (1)

• Oral Health Impact Profile-14 and Provoked Sensitivity (PS),

  baseline and 6th month

Study Arms (3)

Subepithelial Connective Tissue Grafts Group

ACTIVE COMPARATOR

The single incision technique was used as a guide for harvesting the SCTG from the palatal region. After achieving hemostasis in the palatal area, the incision site was primarily closed using 4-0 silk sutures with a cross-suture technique. The graft, held with guide sutures, was slid beneath the interdental papillae and placed into the tunnel bed. The elevated papillary complex was sutured together with the graft using 5-0 monofilament sutures (Neoplene, polypropylene, Turkey) and secured coronally and over the root surface, covering the graft, using vertical double-cross sutures. The surgical procedure, suturing technique, and sutures used on the recipient site were standardized across all groups.

Procedure: Using the tunnel technique in the treatment of gingival recession

•Scalpel-based De-epFGG Group

ACTIVE COMPARATOR

In this group, the De-epFGG technique recommended by Zucchelli et al. was applied. The epithelial layer on the outer surface of the harvested graft was removed by holding a 15C scalpel (Swann-Morton LTD, Sheffield, England) parallel to the surface. The prepared CTG was then placed in the tunnel bed at the desired position using guide sutures.

Procedure: Using the tunnel technique in the treatment of gingival recession

Er,Cr:YSGG Laser-based De-epFGG Group

ACTIVE COMPARATOR

Before the laser application, patients were asked to wear the necessary protective eyewear. The graft dimensions required for the recipient site were marked on the palatal donor area using a 15C scalpel. The donor site was irradiated with a 2780 nm Er,Cr:YSGG laser (WaterLase iPlus; USA Biolase Technology Inc., Irvine, CA), and the de-epithelialization procedure was completed intraorally. The surface layer formed as a result of the laser application was removed using a moist sponge.

Procedure: Using the tunnel technique in the treatment of gingival recession

Interventions

Using the tunnel technique in the treatment of gingival recession PROCEDURE

Microsurgical periodontal instruments were used during surgical procedures. In this study, specially developed tunnel instruments (Helmunt Zepf, Seitingen-Oberflacht, Germany) were used to mobilize the gingivo-papillary unit and prepare the supraperiosteal tunnel bed. After passing the coronal edge of the alveolar bone with the tunnel instrument placed in the soft tissue, it was advanced towards the apical mucogingival junction with small, circular movements. This procedure was repeated by entering from the sulcus of each tooth. Care was taken to ensure that the prepared flaps were in the same layer and opened towards each other. In the interdental areas, the papillary complex was carefully separated from the periosteum and mobilized in the buccal direction. Thus, mobilization of the entire buccal soft tissue complex was achieved in the coronal direction. After these procedures, it was checked whether the flap covered the recession areas without tension.

Also known as: Mucogingival surgery

Er,Cr:YSGG Laser-based De-epFGG Group; Subepithelial Connective Tissue Grafts Group; •Scalpel-based De-epFGG Group

Eligibility Criteria

• Age: 19 Years - 52 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of Miller Class I or II recession defects in at least two adjacent teeth in the maxillary or mandibular arch
• Recession depth ≥ 2 mm
• Recession areas present on intact, caries-free teeth with no restorations

You may not qualify if:

• ▪ History of periodontal surgery in the target area within the past 6 months
• Use of antibiotics within the past 6 months
• Pregnancy or lactation
• Presence of Miller Class III or IV gingival recession
• Recession defects on molar teeth
• Undergoing orthodontic treatment,
• Presence of parafunctional habits
• Individuals with contraindications for periodontal surgery were excluded from the study

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yıl University

Van, 65040, Turkey (Türkiye)

Location

Related Publications (1)

• Bakhishov H, Isler SC, Bozyel B, Yildirim B, Tekindal MA, Ozdemir B. De-epithelialized gingival graft versus subepithelial connective tissue graft in the treatment of multiple adjacent gingival recessions using the tunnel technique: 1-year results of a randomized clinical trial. J Clin Periodontol. 2021 Jul;48(7):970-983. doi: 10.1111/jcpe.13452. Epub 2021 Apr 7.

  PMID: 33751615 RESULT

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• Nazlı Z ALPASLAN

  Ankara Yildirim Beyazit University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: August 3, 2025
• Study Start: October 27, 2021
• Primary Completion: March 24, 2022
• Study Completion: March 24, 2022
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)