- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07526259
Comparative Evaluation of Novel 3D Tunneling Technique Versus Modified Coronally Advanced Tunnel (MCAT) With Connective Tissue Graft in the Management of Multiple RT2 Gingival Recession
Comparative Evaluation of Novel 3D Tunneling Technique Versus Modified Coronally Advanced Tunnel (MCAT) With Connective Tissue Graft in the Management of Multiple RT2 Gingival Recession: A Randomized Controlled Trial
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
AlManial
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Cairo, AlManial, Egypt, 11562
- Recruiting
- Cairo University
-
Contact:
- Riham O Professor, PHD
- Phone Number: +201001405748
- Email: riham.omar@dentistry.cu.edu.eg
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Contact:
- Omar A Ashour, PHD
- Phone Number: +201115537575
- Email: omarmahmoud@dentistry.cu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Buccal and lingual multiple adjacent recession defects classified as Cairo et al RT2.
- Age ≥18 years
- Full mouth plaque index score less than 20% O'Leary et al. 1972
- Patients with healthy systemic condition
- Clinical indication and/or patient request for root coverage
Exclusion Criteria:
- Patients with systemically compromised health
- Periodontal surgical treatment during the previous 24 months in the involved site
- Pregnant or lactating mothers
- Smokers
- Non-compliant patients
- Restored teeth
- Non-carious cervical lesion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Modified coronally advanced tunnel (MCAT)
|
The novel 3D tunneling (3DT) method achieved significant clinical improvement with long term stability in a recent case series.
However, additional research is needed to validate 3DT for its routine clinical use.
|
|
Experimental: novel 3D tunneling (3DT)
|
The novel 3D tunneling (3DT) method achieved significant clinical improvement with long term stability in a recent case series.
However, additional research is needed to validate 3DT for its routine clinical use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Gingival recession depth
Time Frame: From enrollment to the end of treatment at 1 year
|
From enrollment to the end of treatment at 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gingival recession depth lingual
Time Frame: From enrollment to the end of treatment at 1 year
|
From enrollment to the end of treatment at 1 year
|
|
|
Clinical attachment level (CAL) buccal and lingual
Time Frame: From enrollment to the end of treatment at 1 year
|
From enrollment to the end of treatment at 1 year
|
|
|
Periodontal probing depth (PPD) buccal and lingual
Time Frame: From enrollment to the end of treatment at 1 year
|
From enrollment to the end of treatment at 1 year
|
|
|
Width of keratinized tissue (KTW)
Time Frame: From enrollment to the end of treatment at 1 year
|
From enrollment to the end of treatment at 1 year
|
|
|
Papilla tip to contact point distance
Time Frame: From enrollment to the end of treatment at 1 year
|
From enrollment to the end of treatment at 1 year
|
|
|
Mean root coverage
Time Frame: From enrollment to the end of treatment at 1 year
|
From enrollment to the end of treatment at 1 year
|
|
|
Root coverage esthetic score (RES)
Time Frame: From enrollment to the end of treatment at 1 year
|
The RES system evaluates five variables 1 year following surgery: GM, marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC). GM. Zero points = failure of root coverage (gingival margin apical or equal to the baseline recession); 3 points = partial root coverage; 6 points = CRC. MTC. Zero points = irregular gingival margin (does not follow the CEJ); 1 point = proper marginal contour/scalloped gingival margin (follows the CEJ). STT. Zero points = scar formation and/or keloid-like appearance; 1 point = absence of scar or keloid formation. MGJ. Zero points = MGJ not aligned with the MGJ of adjacent teeth; 1 point = MGJ aligned with the MGJ of adjacent teeth. GC. Zero points = color of tissue varies from gingival color at adjacent teeth; 1 point = normal color and integration with the adjacent soft tissues. Thus, the ideal esthetic score is 10. |
From enrollment to the end of treatment at 1 year
|
|
Post operative pain using Visual analogue scale (VAS)
Time Frame: From enrollment to the end of treatment at 1 year
|
Pain score will be reported by the patient directly through Visual Analogue Scale (VAS) score (between 0 and 10.0: no pain, 1: minimal pain, 5: moderate pain, 10: severe pain) will be recorded at day 3, day 7, and day 14.
|
From enrollment to the end of treatment at 1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kazarian E, Inozemtseva K, Lebedeva E. A Novel 3D Tunneling (3DT) Surgical Technique for the Treatment of Gingival Recessions with Reconstruction of the Deficient Interdental Papilla and Interproximal Attachment Regeneration: A Case Series. Int J Periodontics Restorative Dent. 2025 Jan 24;45(1):31-45. doi: 10.11607/prd.6960. PMID: 38198432.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P-E-R-3-3-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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