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Clinical Trials/NCT07100808
NCT07100808CompletedNot Applicable

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

Yuzuncu Yıl University1 site in 1 country60 target enrollmentStarted: October 27, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
The percentage of Root Coverage (RCP)

Study Overview

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).

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
19 Years to 52 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: Using the tunnel technique in the treatment of gingival recession (Procedure)

•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.

Intervention: Using the tunnel technique in the treatment of gingival recession (Procedure)

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.

Intervention: Using the tunnel technique in the treatment of gingival recession (Procedure)

Outcomes

Primary Outcomes

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.

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.

Gingival İndex

Time Frame: Baseline and 6th month

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

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.

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.

Transgingival Gingival Thickness

Time Frame: baseline and 6th month

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

Plaque Index

Time Frame: baseline and 6th month

Silness ve Löe, 1966

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

  • Oral Health Impact Profile-14 and Provoked Sensitivity (PS),(baseline and 6th month)

Investigators

Sponsor
Yuzuncu Yıl University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nazli Zeynep Alpaslan

Associate Professor

Ankara Yildirim Beyazıt University

Study Sites (1)

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