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NCT Number: NCT07200258

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

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.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Complutense of Madrid

Madrid, Spain

Location status: Recruiting

Location contact

tommaso conforti

CONTACT

[email protected]

3383205344

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vestibular Incision Subperiosteal Tunnel Access (VISTA)

Procedure

Remote incisions will be performed in the test group. The VISTA technique will be performed as described by Zadeh (Zadeh, 2011).

After administration of local anaesthesia, an access incision will be made in the vestibulum to permit elevation of a broad subperiosteal tunnel. A specialized periosteal elevator will be used to create the tunnel by dissecting beneath the periosteum, extending at least one tooth beyond the recession defects and under each papilla, without surface incisions at the gingival margin. The connective tissue graft will be inserted and positioned beneath the tunnel through the incision. A coronally anchored suturing technique will be used. This technique mean placing a horizontal mattress suture using a 6.0 suture with at approximately 2 to 3 mm apical to the gingival margin of each tooth, covering the width of the tooth. If keratinized gingiva is present, the suture will be placed within the band of keratinized gingiva.

Modified Coronally Advanced Tunnel (MCAT)

Procedure

In the MCAT group, the surgical approach will follow the technique described by Aroca et al. (2010). After sulcular incisions made without releasing incisions, a full-thickness muco-periosteal tunnel will be carefully elevated beyond the mucogingival junction and under adjacent papillae using tunneling instruments. The root surfaces will be planed, and a subepithelial connective tissue graft will be harvested from the palatal donor site and inserted into the tunnel. Suspended horizontal mattress sutures will be placed around the contact points to advance and stabilize the flap in a position coronal to the cemento-enamel junction (CEJ) (previous composite at the contact point if necessary). Postoperative care will be identical to that described for the VISTA group.

Primary outcomes

  1. Areal Marginal Soft Tissue Thickness (aTHK)

    Time frame: 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 outcomes

  1. Mean Root coverage

    Time frame: 3, 6 and 12 months

    Percentage of root coverage compared with baseline recession depth. Unit of Measure: % Measurement Tool: UNC-15 periodontal probe

  2. Recession Depth

    Time frame: 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

  3. Probing Pocket Depth

    Time frame: 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

  4. Keratinized tissue Width

    Time frame: baseline, 3, 6 and 12 months.

    Distance from gingival margin to mucogingival junction.

    Unit of Measure: mm

    Measurement Tool: UNC-15 periodontal probe

  5. Gingival Thickness

    Time frame: baseline, 3, 6 and 12 months.

    Gingival phenotype assessed by probe transparency.

    Unit of Measure: Thick/Thin (categorical)

    Measurement Tool: UNC-15 periodontal probe

  6. Loss of Attachment

    Time frame: 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

  7. Root Coverage Esthetic Score

    Time frame: 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

  8. Dental Hypersensitivity

    Time frame: 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)

  9. Flap Tension

    Time frame: Baseline

    Residual flap tension during coronal advancement.

    Unit of Measure: Newtons (N)

    Measurement Tool: Calibrated tension meter (Burkhardt & Lang, 2010)

  10. Oral Health Impact Profile

    Time frame: 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

  11. Patients Concerns with recession

    Time frame: 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.

  12. Time to recovery

    Time frame: 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

  13. Digital recession depth

    Time frame: 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

  14. Digital Complete root coverage

    Time frame: 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

  15. Digital Percentage of root coverage

    Time frame: 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

  16. Digital Pointwise Marginal Soft Tissue Thickness

    Time frame: 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

  17. Surgery duration

    Time frame: During Surgery

    Total duration of surgical procedure.

    Unit of Measure: Minutes

    Measurement Tool: Stopwatch (recorded intraoperatively)

  18. Full mouth plaque Score

    Time frame: 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.

  19. Full mouth bleeding Score

    Time frame: 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.

  20. Wound Healing Index

    Time frame: 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

  21. Modified Coronally advanced tunnel Difficulty score (MCATDS) for the treatment of gingival recessions

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Carrillo de Albornoz Sainz

CONTACT

[email protected]

+34 627588248

Tommaso Conforti

CONTACT

[email protected]

+39 3383205344

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

Changes in Soft Tissue Thickness Following Multiple Coronally Advanced Tunnel (MCAT) vs Vestibular Incision Subperiosteal Tunnel Access (VISTA): A Randomized Clinical Trial With 3D Volumetric Analysis

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 1, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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