Can Modified Coronally Advanced Tunnel be an Alternative in Gingival Phenotype Modification?

NCT ID: NCT04690140

Last Updated: 2024-03-06

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-05

Study Completion Date

2020-07-10

Brief Summary

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In the randomized comparative controlled trial, 50 patients with insufficient keratinized tissue at the anterior mandible were treated with either Modified coronally advanced tunnel or epithelialized free gingival graft. At baseline, 6th week, 6th month, 12th-month visits; keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level, were 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.

Detailed Description

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Conditions

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Gingival Phenotype

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Patients were randomly assigned into modified coronally advanced tunnel (n=25) and epithelialized free gingival graft (n=25) groups by one of the authors with an allocation ratio of 1:1 by using a computer-generated program after successful completion of phase I periodontal treatment. One calibrated author masked to the applied surgical technique recorded all clinical variables. The labeled envelope containing the intervention name was opened by the surgeon.

Study Groups

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modified coronally advanced tunnel technique

Initial sulcular incisions and flap separation were then carried out with tunnel knives. Dissection was extended at least 8 mm apically to the mucogingival junction and the muscle attachments were removed with curettes so that the flap could be moved in a coronal direction without tension. Interdental papillae were undermined to prepare the bed for connective tissue graft placement. Connective tissue graft was then inserted under the tunnel at the sites of recession and retracted laterally by sutures towards each end of the tunnel. After connective tissue graft positioning, the flap was gently stretched coronally to obtain passive flap closure. The exposed connective tissue was covered by connecting the adjacent flap margins with additional sutures.

Group Type ACTIVE_COMPARATOR

Modified coronally advanced tunnel technique

Intervention Type PROCEDURE

Connective tissue graft placed under the prepared tunnel

epithelialized free gingival graft

A partial-thickness flap was elevated (blade #15c) with horizontal incisions at the cemento-enamel junction level of the adjacent teeth. Then, two vertical incisions extending to the apical were made from two ends of the horizontal incision. The epithelium in the framed region was removed with a scalpel and the underlying connective tissue was exposed. To achieve the best vascularization from the recipient site, bed preparation was completed with a split-thickness horizontal incision that joins the vertical incisions in the apical region.

Group Type ACTIVE_COMPARATOR

Epithelialized free gingival graft

Intervention Type PROCEDURE

The Epithelialized free gingival graft placed on the prepared bed.

Interventions

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Epithelialized free gingival graft

The Epithelialized free gingival graft placed on the prepared bed.

Intervention Type PROCEDURE

Modified coronally advanced tunnel technique

Connective tissue graft placed under the prepared tunnel

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* presence of at least two anterior mandibular teeth with keratinized tissue height≤1 mm with gingival thickness ≤1mm
* presence of at least two recession type-1 recessions at mandibular anterior teeth and at least one recession with recession depth ≥2 mm,
* aged between 18-60.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Gencay Keceli

Assoc. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Yilmaz BT, Comerdov E, Kutuk C, Nart J, Keceli HG. Modified coronally advanced tunnel versus epithelialized free gingival graft technique in gingival phenotype modification: a comparative randomized controlled clinical trial. Clin Oral Investig. 2022 Oct;26(10):6283-6293. doi: 10.1007/s00784-022-04580-0. Epub 2022 Jun 16.

Reference Type DERIVED
PMID: 35708779 (View on PubMed)

Other Identifiers

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Phenotype Modification

Identifier Type: -

Identifier Source: org_study_id

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