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

NCT07200258 | Recruiting

• 1 other identifier: UCM_MCAT-VISTA RCT
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Areal Marginal Soft Tissue Thickness (aTHK)

  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.

  Baseline, 3, 6 and 12 months post-surgery

Secondary Outcomes (21)

• Mean Root coverage

  3, 6 and 12 months

• Recession Depth

  Baseline, 3 , 6 and 12 months

• Probing Pocket Depth

  baseline, 3, 6 and 12 months.

• Keratinized tissue Width

  baseline, 3, 6 and 12 months.

• Gingival Thickness

  baseline, 3, 6 and 12 months.

Study Arms (2)

Arm 1 : Vestibular Incision Subperiosteal Tunnel Access (VISTA)

EXPERIMENTAL

Patients in this arm will receive the Vestibular Incision Subperiosteal Tunnel Access (VISTA) technique, involving remote vestibular incisions and subperiosteal tunneling to treat multiple gingival recessions. A connective tissue graft (CTG) will be inserted and stabilized using a coronally anchored suturing technique.

Procedure: Vestibular Incision Subperiosteal Tunnel Access (VISTA)

Arm 2 : Modified Coronally Advanced Tunnel Technique (MCAT)

EXPERIMENTAL

Procedure: Modified Coronally Advanced Tunnel (MCAT)

Interventions

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.

Arm 1 : Vestibular Incision Subperiosteal Tunnel Access (VISTA)

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.

Arm 2 : Modified Coronally Advanced Tunnel Technique (MCAT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

University Complutense of Madrid

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Central Study Contacts

Ana Carrillo de Albornoz Sainz

CONTACT

+34 627588248; acarri02@ucm.es

Tommaso Conforti

CONTACT

+39 3383205344; tommconf@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: October 1, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-01

Locations

ES (1)