Clinical Outcomes of Enamel Matrix Derivative and Connective Tissue Graft in Modified Coronally Advanced Tunnel (MCAT)

NCT ID: NCT06504329

Last Updated: 2025-06-24

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-24

Study Completion Date

2025-01-24

Brief Summary

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This study investigates the treatment of gingival recession (specifically Miller Class I and II defects) using a minimally invasive surgical approach known as the modified coronally advanced tunnel (MCAT) technique. Participants are allocated into three groups: one receiving subepithelial connective tissue grafts (SCTG), another treated with enamel matrix derivatives (EMD), and a third group receiving a combination of SCTG and EMD.

The primary objective is to evaluate the clinical effectiveness of each treatment modality in terms of root coverage, esthetic outcomes, and postoperative patient comfort. The study also aims to determine whether the combined use of SCTG and EMD provides superior clinical results compared to their individual application. Both short-term and long-term treatment outcomes are assessed to identify the most effective approach for managing gingival recession.

Detailed Description

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This randomized controlled clinical trial aims to evaluate both the short- and long-term clinical outcomes of the modified coronally advanced tunnel (MCAT) technique combined with various biomaterials in the treatment of Miller Class I and II gingival recession defects.

A total of 60 systemically healthy individuals, aged between 18 and 60 years, presenting to the Department of Periodontology at Necmettin Erbakan University Faculty of Dentistry with gingival recession complaints will be included. Prior to enrollment, all participants will undergo routine periodontal examinations and nonsurgical Phase I therapy. Standard mucogingival procedures are routinely performed at this institution.

Participants will be randomly assigned to one of the following three treatment groups (n=20 each):

Group 1: MCAT + subepithelial connective tissue graft (SCTG) Group 2: MCAT + enamel matrix derivative (EMD) Group 3: MCAT + SCTG + EMD Clinical Evaluations

Clinical assessments will be conducted at baseline, 3 months, and 6 months postoperatively and will include the following parameters:

Plaque Index (PI): Assessed according to Silness and Löe (1964). Gingival Index (GI): Assessed according to Löe and Silness (1963). Gingival Recession Width (GRW): Measured horizontally at the widest point. Gingival Recession Height (GRH): Measured from the cementoenamel junction (CEJ) to the gingival margin. Keratinized Tissue Width (KTW): Measured from the gingival margin to the mucogingival junction. Probing Depth (PD) and Clinical Attachment Level (CAL): Measured at baseline and 6 months.

PD is recorded from the gingival margin to the apical extent of the sulcus; CAL is measured from the CEJ to the base of the sulcus. Intraoral Photographs: Captured at all evaluation time points. Gingival thickness will be assessed under topical anesthesia at the mid-buccal aspect, 2 mm apical to the gingival margin, using an endodontic file fitted with a rubber stopper. The distance from the file tip to the stopper will be recorded using a digital caliper.

The percentage of root coverage will be calculated based on clinical measurements, following the standardized formula described by Al-Hamdan et al. (2003).

Wound Healing Evaluation:

Sutures will be removed on postoperative day 14. Wound healing will be assessed individually for each treated site using the wound healing index proposed by Huang et al. (2005).

This study aims to provide comprehensive insights into the clinical effectiveness, esthetic outcomes, and patient-reported comfort associated with the MCAT technique when used alone or in combination with SCTG and/or EMD for the treatment of gingival recession defects.

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Modified Coronally Advanced Tunnel (MCAT) + Subepithelial Connective Tissue Graft (SCTG)

Participants in this arm receive the modified coronally advanced tunnel (MCAT) technique in combination with a subepithelial connective tissue graft (SCTG).

Group Type EXPERIMENTAL

Modified Coronally Advanced Tunnel (MCAT) + Subepithelial Connective Tissue Graft (SCTG)

Intervention Type PROCEDURE

The modified coronally advanced tunnel (MCAT) technique is performed to prepare a recipient site. A subepithelial connective tissue graft (SCTG), harvested from the palate, is inserted into the tunnel using guiding sutures and stabilized. The flap is advanced coronally to completely cover the graft and achieve primary closure.

Modified Coronally Advanced Tunnel (MCAT) + Enamel Matrix Derivative (EMD)

Participants in this arm receive the modified coronally advanced tunnel (MCAT) technique along with application of Emdogain (0.15 ml gel form), used as an enamel matrix derivative (EMD) to promote periodontal tissue regeneration.

Group Type EXPERIMENTAL

Modified Coronally Advanced Tunnel (MCAT) + Enamel Matrix Derivative (EMD)

Intervention Type PROCEDURE

This intervention involves the application of enamel matrix derivative (EMD; Emdogain, 0.15 ml gel form) in conjunction with the modified coronally advanced tunnel (MCAT) technique. Following tunnel preparation, EMD is applied to the exposed root surface to enhance periodontal tissue regeneration.

MCAT + Subepithelial Connective Tissue Graft (SCTG) + Enamel Matrix Derivative (EMD)

Participants in this arm receive the modified coronally advanced tunnel (MCAT) technique in combination with a subepithelial connective tissue graft and application of an enamel matrix derivative (EMD; Emdogain, 0.15 ml gel form) to support periodontal tissue regeneration.

Group Type EXPERIMENTAL

Modified Coronally Advanced Tunnel (MCAT) + Subepithelial Connective Tissue Graft (SCTG)

Intervention Type PROCEDURE

The modified coronally advanced tunnel (MCAT) technique is performed to prepare a recipient site. A subepithelial connective tissue graft (SCTG), harvested from the palate, is inserted into the tunnel using guiding sutures and stabilized. The flap is advanced coronally to completely cover the graft and achieve primary closure.

Modified Coronally Advanced Tunnel (MCAT) + Enamel Matrix Derivative (EMD)

Intervention Type PROCEDURE

This intervention involves the application of enamel matrix derivative (EMD; Emdogain, 0.15 ml gel form) in conjunction with the modified coronally advanced tunnel (MCAT) technique. Following tunnel preparation, EMD is applied to the exposed root surface to enhance periodontal tissue regeneration.

Interventions

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Modified Coronally Advanced Tunnel (MCAT) + Subepithelial Connective Tissue Graft (SCTG)

The modified coronally advanced tunnel (MCAT) technique is performed to prepare a recipient site. A subepithelial connective tissue graft (SCTG), harvested from the palate, is inserted into the tunnel using guiding sutures and stabilized. The flap is advanced coronally to completely cover the graft and achieve primary closure.

Intervention Type PROCEDURE

Modified Coronally Advanced Tunnel (MCAT) + Enamel Matrix Derivative (EMD)

This intervention involves the application of enamel matrix derivative (EMD; Emdogain, 0.15 ml gel form) in conjunction with the modified coronally advanced tunnel (MCAT) technique. Following tunnel preparation, EMD is applied to the exposed root surface to enhance periodontal tissue regeneration.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Adults aged between 18 and 60 years

Systemically and periodontally healthy individuals

Non-smokers

Presence of a clearly detectable cementoenamel junction (CEJ)

No prior surgical intervention at the selected sites

No periodontal pockets deeper than 3 mm

No signs of occlusal trauma

Exclusion Criteria

Pregnancy or lactation

Use of antibiotics in the past 6 months

Presence of any systemic condition that may contraindicate periodontal surgery, including:

Diabetes mellitus

Impaired glucose tolerance

Endocrine disorders

Cardiovascular diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Necmettin Erbakan University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Altıparmak

DDS, Research Assistant in the Department of Periodontology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Necmettin Erbakan University, Faculty of Dentistry

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MCAT - microsurgery

Identifier Type: -

Identifier Source: org_study_id

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