Changes in Soft Tissue Thickness Following Multiple Coronally Advanced Tunnel (MCAT) vs Vestibular Incision Subperiosteal Tunnel Access (VISTA)

Not Applicable

Not yet recruiting

• Conditions: Gingival Recession

• Registration Number: NCT07200258
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

This randomized clinical trial will compare two surgical methods for treating multiple adjacent gingival recessions (types RT1 and RT2): the Modified Coronally Advanced Tunnel (MCAT) and the Vestibular Incision Subperiosteal Tunnel Access (VISTA). Both methods will use connective tissue grafts (CTG), which are the best way to cover roots.

The main objective is to use three-dimensional (3D) digital volumetric analysis to look at how the thickness of soft tissue has changed after six and 12 months. Secondary outcomes include root coverage, esthetic outcomes, gingival health parameters, hypersensitivity, patient satisfaction, and wound healing quality.

There will be 44 volunteers, and they will be randomly assigned to one of the two surgical methods. Under the same settings, periodontal specialists in training will undertake the procedures at the Universidad Complutense de Madrid. There will be follow-up evaluations at different times up to 12 months after the procedure. The results of this study will help determine whether remote incisions via the VISTA technique offer improved outcomes compared to the MCAT technique.

Detailed Description

Parallel group, clinical evaluator and statistician blinded, randomized clinical trial.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-14
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Study Start: 2025-10-15
• Primary Completion: 2027-07
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Periodontally and systemically healthy adults (age ≥ 18 years).
• At least two adjacent sites exhibiting gingival recessions classified as recession type 1 (RT1) o type 2 (RT2) (Cairo et al., 2011), associated with dental hypersensitivity or aesthetic concerns.
• Presence ≥2 mm depth on at least one recession
• Smokers ≤ 10 cigarettes.
• Full-mouth plaque and bleeding scores ≤20%.
• Patients being able to maintain good oral hygiene.

Exclusion Criteria

• Compromised general health.
• Pregnancy or attempting to get pregnant (self-reported).
• Untreated periodontal diseases
• Presence of: (i) severe tooth malposition; (ii) root caries or inadequate prosthetic restorations; (iii) previous periodontal plastic surgery at the experimental sites.
• Smokers >10 cigarettes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Areal Marginal Soft Tissue Thickness (aTHK)	Baseline, 3, 6 and 12 months post-surgery	Soft tissue thickness will be measured using volumetric analysis of STL digital intraoral scans. The region of interest (ROI) corresponds to the previously exposed root surface. The volume difference between baseline and follow-up scans (6 months) will be divided by the surface area leading to an areal thickness (aTHK), expressed in millimeters.

Secondary Outcome Measures

Name	Time	Method
Mean Root coverage	3, 6 and 12 months	Percentage of root coverage compared with baseline recession depth. Unit of Measure: % Measurement Tool: UNC-15 periodontal probe
Recession Depth	Baseline, 3 , 6 and 12 months	Distance from gingival margin to cemento-enamel junction (GM-CEJ). Unit of Measure: mm Measurement Tool: UNC-15 periodontal probe
Probing Pocket Depth	baseline, 3, 6 and 12 months.	Distance from the gingival margin to the bottom of the sulcus at the mid-buccal site.; Unit of Measure: mm Measurement Tool: UNC-15 periodontal probe
Keratinized tissue Width	baseline, 3, 6 and 12 months.	Distance from gingival margin to mucogingival junction.; Unit of Measure: mm; Measurement Tool: UNC-15 periodontal probe
Gingival Thickness	baseline, 3, 6 and 12 months.	Gingival phenotype assessed by probe transparency.; Unit of Measure: Thick/Thin (categorical); Measurement Tool: UNC-15 periodontal probe
Loss of Attachment	Baseline, 3, 6 and 12 months.	Presence or absence of interproximal clinical attachment loss at treated sites.; Unit of Measure: mm; Measurement Tool: UNC-15 periodontal probe
Root Coverage Esthetic Score	3 6 and 12 months.	Esthetic evaluation of root coverage outcomes (0-10 composite score).; Unit of Measure: Score (0-10); Measurement Tool: RES index (Cairo 2009) from standardized photographs
Dental Hypersensitivity	baseline, 3, 6 and 12 months	Sensitivity to air stimulus at cervical area.; Unit of Measure: Frequency (%) of teeth with sensitivity; Measurement Tool: Standardized air-blast test (10 seconds)
Flap Tension	Baseline	Residual flap tension during coronal advancement.; Unit of Measure: Newtons (N); Measurement Tool: Calibrated tension meter (Burkhardt \& Lang, 2010)
Oral Health Impact Profile	Baseline, 3 6 and 12 month	Patient-reported outcomes using the OHIP-14 questionnaire.; Unit of Measure: Score (0-56; higher = worse QoL); Measurement Tool: Validated Spanish version of OHIP-14
Patients Concerns with recession	Baseline, 6 and 12 month	Patient concerns related to gingival recession will be measured with a condition-specific health-related quality-of-life instrument using a custom 5-point Likert-scale questionnaire assessing five questions: esthetic concern, sensitivity to cold, sensitivity to brushing, root/tooth wear, and fear of tooth loss. Each item is rated from 1 ("not concerned") to 5 ("extremely concerned"). Changes in scores over time will be used to evaluate perceived improvement.
Time to recovery	from baseline to 14 days post surgery	Number of days until patient-reported recovery after surgery. Recovery is defined as "no or slight trouble" (score 1-2) on all items of the Post-op diary, and pain ≤2 cm on VAS.; Unit of Measure: Days; Measurement Tool: Periodontal Surgery Post-op (PS Postop) diary with VAS (0-10 cm) and Likert scales
Digital recession depth	Baseline, 3 6 and 12 month	Apico-coronal extension of recession measured digitally.; Unit of Measure: mm; Measurement Tool: Intraoral scanner (3Shape TRIOS) and Nemotec software
Digital Complete root coverage	Baseline, 3 6 and 12 month	Whether gingival margin reached/surpassed CEJ.; Unit of Measure: Binary (Yes/No); Measurement Tool: Intraoral scanner (3Shape TRIOS) and Nemotec software
Digital Percentage of root coverage	Baseline, 3 6 and 12 month	Percentage of root coverage compared with baseline, digitally measured.; Unit of Measure: %; Measurement Tool: Intraoral scanner (3Shape TRIOS) and Nemotec software
Digital Pointwise Marginal Soft Tissue Thickness	Baseline, 3 6 and 12 month	Gingival thickness at specific points in cross-section.; Unit of Measure: mm; Measurement Tool: Intraoral scanner (3Shape TRIOS) and Nemotec software
Surgery duration	During Surgery	Total duration of surgical procedure.; Unit of Measure: Minutes; Measurement Tool: Stopwatch (recorded intraoperatively)
Full mouth plaque Score	Baseline 3 6 and 12 months	Plaque presence will be recorded at six sites per tooth using a periodontal probe and expressed as the percentage of plaque-positive sites over the total number of sites examined.
Full mouth bleeding Score	Baseline, 3 6 and 12 month	Bleeding on probing will be recorded at six sites per tooth. The FMBS will be calculated as the percentage of sites showing bleeding after probing with a periodontal probe over the total number of sites examined.
Wound Healing Index	Day 7, week 2 , Week 4 and 3 months	Wound healing will be evaluated using a modified semi-quantitative composite index based on the methodology described by Tonetti (Tonetti et al., 2018).; Healing is assessed evaluating four variables.; Flap Margin Assessment; Papillae Evaluation; Graft Site Examination; Suture Evaluation
Modified Coronally advanced tunnel Difficulty score (MCATDS) for the treatment of gingival recessions	Baseline	The MCATDS, developed by Górski in 2025 (Gorski et al. 2025), is a standardized scoring system to assess the complexity of treating multiple gingival recessions using the MCAT technique.; The parameters include: * Tooth position (maxillary vs mandibular); * Tooth type (incisor/canine, premolar, molar); * Recession type (RT1, RT2, RT3); * Recession depth (\<4 mm vs ≥4 mm); * Number of recessions involved (≤2, 3-4, ≥5); * Uniformity of recession sizes; * Baseline keratinized tissue height; * Gingival biotype (thick vs thin); * Frenulum presence and distance to gingival margin; * Presence of scar tissue; * Detectability of the cemento-enamel junction (CEJ); * Cervical step (\>0.5 mm); * Tooth malposition; Each parameter contributes between 0 and 2 points. The total score ranges from 0 to 17, and difficulty is categorized as: * Easy (0-5 points): Suitable for novice clinicians; * Moderate (6-11 points): Requires experienced operators; * Difficult (12-17 points): Reserved for highly skilled surgeons