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

NCT ID: NCT07100808

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-27

Study Completion Date

2022-03-24

Brief Summary

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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).

Detailed Description

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Gingival recession is not only one of the most common aesthetic and functional problems of the periodontium, but also one of the most complex conditions in terms of etiology and treatment modalities. Subepithelial connective tissue grafts (SCTG), applied in combination with various techniques, are considered the gold standard in the treatment of gingival recession. In cases where a surgical approach is indicated, coronally advanced flap (CAF) or graft-based subepithelial connective tissue procedures in combination with the tunnel technique (TT) have been reported to be successfully utilized.

The use of de-epithelialized free gingival graft (De-epFGG) as a connective tissue graft (CTG) represents another treatment option for managing gingival recession.

With advancements in laser technology, lasers with various wavelengths are increasingly being used as alternatives to scalpels in numerous intraoral surgical procedures. Considering the advantageous properties of erbium lasers, which are among the most prominent dental lasers, their use has also been demonstrated for preparing recipient sites for free gingival grafts (FGG). There are only a limited number of studies in the literature investigating the combination of De-epithelialized Free Gingival Graft (De-epFGG) with the Tunnel Technique (TT). The aim of this study is to evaluate the clinical effectiveness of SCTG, scalpel-based De-epFGG, and Er,Cr:YSGG laser-based De-epFGG techniques, all applied in combination with the tunnel technique, in the treatment of Miller Class I and II multiple gingival recessions.

The study hypothesis is that the percentage of root coverage achieved using De-epFGG (scalpel and laser methods) would be comparable and that these methods could serve as strong alternatives to SCTG.

Conditions

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Gingival Recessions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Subepithelial Connective Tissue Grafts Group

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.

Group Type ACTIVE_COMPARATOR

Using the tunnel technique in the treatment of gingival recession

Intervention Type 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.

•Scalpel-based De-epFGG Group

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.

Group Type ACTIVE_COMPARATOR

Using the tunnel technique in the treatment of gingival recession

Intervention Type 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.

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

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.

Group Type ACTIVE_COMPARATOR

Using the tunnel technique in the treatment of gingival recession

Intervention Type 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.

Interventions

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Using the tunnel technique in the treatment of gingival recession

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.

Intervention Type PROCEDURE

Other Intervention Names

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Mucogingival surgery

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* ▪ 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

52 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuzuncu Yıl University

OTHER

Sponsor Role lead

Responsible Party

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Nazli Zeynep Alpaslan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nazlı Z ALPASLAN

Role: PRINCIPAL_INVESTIGATOR

Ankara Yildirim Beyazit University, Faculty of Dentistry

Locations

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Van Yuzuncu Yıl University

Van, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 33751615 (View on PubMed)

Other Identifiers

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17.06.2020/14

Identifier Type: -

Identifier Source: org_study_id

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