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Completed

NCT Number: NCT07100808

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

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).

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Key information

Conditions

Gingival Recessions Gingival Diseases Gingival Recession Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

19 year–52 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Yuzuncu Yıl University

Van, 65040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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.

Other names: Mucogingival surgery

Primary outcomes

  1. The percentage of Root Coverage (RCP)

    Time frame: Baseline and 6 months

    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.

  2. Clinical Attachment Level

    Time frame: baseline and 6th months

    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.

  3. Recession Depth

    Time frame: baseline and 6th month

    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.

  4. Width of Keratinized Tissue

    Time frame: baseline and 6th month

    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.

  5. Transgingival Gingival Thickness

    Time frame: baseline and 6th month

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

  6. Gingival İndex

    Time frame: Baseline and 6th month

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

  7. Plaque Index

    Time frame: baseline and 6th month

    Silness ve Löe, 1966

  8. Probing Depth

    Time frame: baseline and 6th month

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

Secondary outcomes

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

    Time frame: baseline and 6th month

    Postoperative morbidity was assessed using quality of life measurements (Oral Health Impact Profile-14, OHIP-14), provoked sensitivity (PS), and the operation durations of the groups. PS was evaluated preoperatively at the recession sites to detect dentin hypersensitivity by applying a 3-second air spray provocation administered by the clinician.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

Evaluation of Clinical Efficacy of Subepithelial Connective Tissue Graft and Free Gingival Graft De-Epithelialized With Two Different Methods in the Treatment of Gingival Recessions

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

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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