Clinical Outcomes of Enamel Matrix Derivative and Connective Tissue Graft in Modified Coronally Advanced Tunnel (MCAT)
MCAT
1 other identifier
interventional
52
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 24, 2024
CompletedFirst Submitted
Initial submission to the registry
July 1, 2024
CompletedFirst Posted
Study publicly available on registry
July 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2025
CompletedJune 24, 2025
June 1, 2025
6 months
July 1, 2024
June 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
6 months postoperatively
Secondary Outcomes (9)
Gingival Index (GI)
Baseline, 1, 3, and 6 months postoperatively
Plaque Index (PI)
Baseline, 1, 3, and 6 months postoperatively.
Gingival Recession Height (GRH)
Baseline, 1, 3, and 6 months postoperatively
Gingival Recession Width (GRW)
Baseline, 1, 3, and 6 months postoperatively.
Clinical Attachment Level (CAL)
Baseline and 6 months postoperatively.
- +4 more secondary outcomes
Study Arms (3)
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).
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.
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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Necmettin Erbakan University, Faculty of Dentistry
Konya, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DDS, Research Assistant in the Department of Periodontology
Study Record Dates
First Submitted
July 1, 2024
First Posted
July 16, 2024
Study Start
January 24, 2024
Primary Completion
July 24, 2024
Study Completion
January 24, 2025
Last Updated
June 24, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share