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Gingival RecessionMCATNCT06504329

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

A study testing Modified Coronally Advanced Tunnel (MCAT) + Subepithelial Connective Tissue Graft (SCTG) and Modified Coronally Advanced Tunnel (MCAT) + Enamel Matrix Derivative (EMD) in people with Gingival Recession, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Recession
What is being tested?
Modified Coronally Advanced Tunnel (MCAT) + Subepithelial Connective Tissue Graft (SCTG) and Modified Coronally Advanced Tunnel (MCAT) + Enamel Matrix Derivative (EMD)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteTurkey (Türkiye)
Study dates
24 Jan 2024to 24 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • Declined to participate or failed to meet inclusion criteria

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Necmettin Erbakan University, Faculty of Dentistry

    Konya

Other trials in Turkey (Türkiye)

About this study

Official title: Clinical Outcomes of Enamel Matrix Derivative and Connective Tissue Graft in Modified Coronally Advanced Tunnel: A Randomized Controlled Trial

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.

Read the detailed description

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.

Being tested
Modified Coronally Advanced Tunnel (MCAT) + Subepithelial Connective Tissue Graft (SCTG), Modified Coronally Advanced Tunnel (MCAT) + Enamel Matrix Derivative (EMD)
Keywords
Gingival recession, modified coronally advanced tunnel, enamel matrix derivative, subepithelial connective tissue graft
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified Coronally Advanced Tunnel (MCAT) + Subepithelial Connective Tissue Graft (SCTG)Procedure or surgery

    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)Procedure or surgery

    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.

Study groups in NCT06504329
Study groupRoleWhat they receive
Modified Coronally Advanced Tunnel (MCAT) + Subepithelial Connective Tissue Graft (SCTG)ExperimentalParticipants in this arm receive the modified coronally advanced tunnel (MCAT) technique in combination with a subepithelial connective tissue graft (SCTG).
Receives: Procedure: Modified Coronally Advanced Tunnel (MCAT) + Subepithelial Connective Tissue Graft (SCTG)
Modified Coronally Advanced Tunnel (MCAT) + Enamel Matrix Derivative (EMD)ExperimentalParticipants 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.
Receives: Procedure: Modified Coronally Advanced Tunnel (MCAT) + Enamel Matrix Derivative (EMD)
MCAT + Subepithelial Connective Tissue Graft (SCTG) + Enamel Matrix Derivative (EMD)ExperimentalParticipants 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.
Receives: Procedure: Modified Coronally Advanced Tunnel (MCAT) + Subepithelial Connective Tissue Graft (SCTG); Procedure: Modified Coronally Advanced Tunnel (MCAT) + Enamel Matrix Derivative (EMD)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Root Surface Coverage (%RC)

    The percentage of root surface coverage will be calculated based on changes in the exposed root surface area before and after treatment. The exposed area is estimated by multiplying the height and width of the gingival recession. The difference between the baseline and 6-month postoperative values will be used to determine the percentage of coverage. Results will be expressed as a percentage (%). This approach reflects the clinical effectiveness of the intervention and is based on the method described by Al-Hamdan et al. (2003).

    Measured: 6 months postoperatively

Secondary outcomes (9)
  1. Gingival Index (GI)

    Gingival inflammation will be scored using the Löe and Silness Gingival Index (1963), with scores ranging from 0 (normal) to 3 (severe inflammation).

    Measured: Baseline, 1, 3, and 6 months postoperatively

  2. Plaque Index (PI)

    Oral hygiene will be assessed using the Silness and Löe Plaque Index (1964), scored from 0 (no plaque) to 3 (abundant plaque accumulation).

    Measured: Baseline, 1, 3, and 6 months postoperatively.

  3. Gingival Recession Height (GRH)

    Gingival recession height will be measured in millimeters from the cementoenamel junction (CEJ) to the gingival margin using a periodontal probe.

    Measured: Baseline, 1, 3, and 6 months postoperatively

  4. Gingival Recession Width (GRW)

    Gingival recession width will be measured in millimeters as the horizontal distance between the mesial and distal borders of the recession at its widest point. A periodontal probe will be positioned parallel to the cementoenamel junction to record the measurement.

    Measured: Baseline, 1, 3, and 6 months postoperatively.

  5. Clinical Attachment Level (CAL)

    Clinical attachment level will be measured in millimeters as the distance from the cementoenamel junction (CEJ) to the base of the sulcus using a periodontal probe at the mid-vestibular aspect of the tooth.

    Measured: Baseline and 6 months postoperatively.

  6. Keratinized Tissue Width (KTW)

    Keratinized tissue width (in millimeters) will be measured from the free gingival margin to the mucogingival junction using a periodontal probe. Measurements will be taken at the mid-point of the recession site.

    Measured: Baseline, 1, 3, and 6 months postoperatively.

  7. Gingival Thickness

    Gingival thickness (in millimeters) will be measured at the mid-buccal region, 2 mm apical to the gingival margin, under topical anesthesia. A #25 endodontic spreader with a rubber stopper will be inserted perpendicular to the gingival surface until contact with hard tissue is achieved. The distance from the tip to the stopper will be recorded using a digital caliper.

    Measured: Baseline and 6 months postoperatively.

  8. Wound Healing Index (WHI)

    ound healing will be assessed two weeks postoperatively upon suture removal, using the Wound Healing Index (WHI) as defined by Huang et al. (2005). Each surgical site will be scored as follows:

    Score 1: Uneventful healing without gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence.

    Score 2: Slight edema, erythema, patient discomfort, or flap dehiscence, but without suppuration or infection.

    Score 3: Poor healing with significant edema, erythema, patient discomfort, flap dehiscence, or presence of infection.

    Measured: 2 weeks postoperatively.

  9. Probing Depth (PD)

    Probing depth will be measured using a Williams periodontal probe (Hu-Friedy) at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual), parallel to the tooth's long axis. The probe will be inserted with gentle pressure (~0.25 N) until slight resistance is felt at the base of the sulcus. The distance from the free gingival margin to the base of the pocket will be recorded in millimeters and rounded to the nearest whole number.

    Measured: Baseline and 6 months postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2024
  2. Study start24 Jan 2024
  3. Primary completion24 Jul 2024
  4. Study completion24 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06504329
Sponsor's protocol ID
MCAT - microsurgery
Acronym
MCAT
Status last verified
Jun 2025
First submitted
1 Jul 2024
Last updated
24 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Altiparmak F, Yarkac FU. Clinical and aesthetic outcomes of enamel matrix derivative and subepithelial connective tissue graft using the modified coronally advanced tunnel technique: a randomized controlled trial. J Appl Oral Sci. 2026 Mar 23;34:e20250775. doi: 10.1590/1678-7765-2025-0775. eCollection 2026.

    PubMed 41880469

Questions about this trial

What is this clinical trial studying?

A study testing Modified Coronally Advanced Tunnel (MCAT) + Subepithelial Connective Tissue Graft (SCTG) and Modified Coronally Advanced Tunnel (MCAT) + Enamel Matrix Derivative (EMD) in people with Gingival Recession, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Root Surface Coverage (%RC) (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06504329, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.

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