Gingival RecessionNCT07200258
Changes in Soft Tissue Thickness Following Multiple Coronally Advanced Tunnel (MCAT) vs Vestibular Incision Subperiosteal Tunnel Access (VISTA)
A study testing Vestibular Incision Subperiosteal Tunnel Access (VISTA) and Modified Coronally Advanced Tunnel (MCAT) in people with Gingival Recession, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Vestibular Incision Subperiosteal Tunnel Access (VISTA) and Modified Coronally Advanced Tunnel (MCAT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University Complutense of Madrid
Madrid
tommaso conforti, 3383205344, tommaso.conf@gmail.com
About this study
Official 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
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.
Read the detailed description
Parallel group, clinical evaluator and statistician blinded, randomized clinical trial.
- Conditions
- Gingival Recession
- Being tested
- Vestibular Incision Subperiosteal Tunnel Access (VISTA), Modified Coronally Advanced Tunnel (MCAT)
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Incision Subperiosteal Tunnel Access (VISTA)Procedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Vestibular Incision Subperiosteal Tunnel Access (VISTA) |
| Arm 2 : Modified Coronally Advanced Tunnel Technique (MCAT) | Experimental | Not described Receives: Procedure: Modified Coronally Advanced Tunnel (MCAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3, 6 and 12 months post-surgery
Secondary outcomes (21)
Mean Root coverage
Percentage of root coverage compared with baseline recession depth. Unit of Measure: % Measurement Tool: UNC-15 periodontal probe
Measured: 3, 6 and 12 months
Recession Depth
Distance from gingival margin to cemento-enamel junction (GM-CEJ). Unit of Measure: mm Measurement Tool: UNC-15 periodontal probe
Measured: Baseline, 3 , 6 and 12 months
Probing Pocket Depth
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
Measured: baseline, 3, 6 and 12 months.
Keratinized tissue Width
Distance from gingival margin to mucogingival junction.
Unit of Measure: mm
Measurement Tool: UNC-15 periodontal probe
Measured: baseline, 3, 6 and 12 months.
Gingival Thickness
Gingival phenotype assessed by probe transparency.
Unit of Measure: Thick/Thin (categorical)
Measurement Tool: UNC-15 periodontal probe
Measured: baseline, 3, 6 and 12 months.
Loss of Attachment
Presence or absence of interproximal clinical attachment loss at treated sites.
Unit of Measure: mm
Measurement Tool: UNC-15 periodontal probe
Measured: Baseline, 3, 6 and 12 months.
Root Coverage Esthetic Score
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
Measured: 3 6 and 12 months.
Dental Hypersensitivity
Sensitivity to air stimulus at cervical area.
Unit of Measure: Frequency (%) of teeth with sensitivity
Measurement Tool: Standardized air-blast test (10 seconds)
Measured: baseline, 3, 6 and 12 months
Flap Tension
Residual flap tension during coronal advancement.
Unit of Measure: Newtons (N)
Measurement Tool: Calibrated tension meter (Burkhardt \& Lang, 2010)
Measured: Baseline
Oral Health Impact Profile
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
Measured: Baseline, 3 6 and 12 month
Patients Concerns with recession
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.
Measured: Baseline, 6 and 12 month
Time to recovery
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
Measured: from baseline to 14 days post surgery
Digital recession depth
Apico-coronal extension of recession measured digitally.
Unit of Measure: mm
Measurement Tool: Intraoral scanner (3Shape TRIOS) and Nemotec software
Measured: Baseline, 3 6 and 12 month
Digital Complete root coverage
Whether gingival margin reached/surpassed CEJ.
Unit of Measure: Binary (Yes/No)
Measurement Tool: Intraoral scanner (3Shape TRIOS) and Nemotec software
Measured: Baseline, 3 6 and 12 month
Digital Percentage of root coverage
Percentage of root coverage compared with baseline, digitally measured.
Unit of Measure: %
Measurement Tool: Intraoral scanner (3Shape TRIOS) and Nemotec software
Measured: Baseline, 3 6 and 12 month
Digital Pointwise Marginal Soft Tissue Thickness
Gingival thickness at specific points in cross-section.
Unit of Measure: mm
Measurement Tool: Intraoral scanner (3Shape TRIOS) and Nemotec software
Measured: Baseline, 3 6 and 12 month
Surgery duration
Total duration of surgical procedure.
Unit of Measure: Minutes
Measurement Tool: Stopwatch (recorded intraoperatively)
Measured: During Surgery
Full mouth plaque Score
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.
Measured: Baseline 3 6 and 12 months
Full mouth bleeding Score
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.
Measured: Baseline, 3 6 and 12 month
Wound Healing Index
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
Measured: Day 7, week 2 , Week 4 and 3 months
Modified Coronally advanced tunnel Difficulty score (MCATDS) for the treatment of gingival recessions
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start15 Oct 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200258
- Sponsor's protocol ID
- UCM_MCAT-VISTA RCT
- Status last verified
- Jan 2026
- First submitted
- 14 Jul 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07200258
- Acronym / sponsor ID
- UCM_MCAT-VISTA RCT
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 : Vestibular Incision Subperiosteal Tunnel Access (VISTA) | Experimental | Procedure: Vestibular Incision Subperiosteal Tunnel Access (VISTA)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. |
| Arm 2 : Modified Coronally Advanced Tunnel Technique (MCAT) | Experimental | Procedure: Modified Coronally Advanced Tunnel (MCAT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular Incision Subperiosteal Tunnel Access (VISTA)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. | Procedure or surgery | Arm 1 : Vestibular Incision Subperiosteal Tunnel Access (VISTA) |
| Modified Coronally Advanced Tunnel (MCAT)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. | Procedure or surgery | Arm 2 : Modified Coronally Advanced Tunnel Technique (MCAT) |
Primary outcome
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.
21 secondary outcomes
Mean Root coverage
Time frame: 3, 6 and 12 months
Recession Depth
Time frame: Baseline, 3 , 6 and 12 months
Probing Pocket Depth
Time frame: baseline, 3, 6 and 12 months.
Keratinized tissue Width
Time frame: baseline, 3, 6 and 12 months.
Gingival Thickness
Time frame: baseline, 3, 6 and 12 months.
Loss of Attachment
Time frame: Baseline, 3, 6 and 12 months.
Root Coverage Esthetic Score
Time frame: 3 6 and 12 months.
Dental Hypersensitivity
Time frame: baseline, 3, 6 and 12 months
Flap Tension
Time frame: Baseline
Oral Health Impact Profile
Time frame: Baseline, 3 6 and 12 month
Patients Concerns with recession
Time frame: Baseline, 6 and 12 month
Time to recovery
Time frame: from baseline to 14 days post surgery
Digital recession depth
Time frame: Baseline, 3 6 and 12 month
Digital Complete root coverage
Time frame: Baseline, 3 6 and 12 month
Digital Percentage of root coverage
Time frame: Baseline, 3 6 and 12 month
Digital Pointwise Marginal Soft Tissue Thickness
Time frame: Baseline, 3 6 and 12 month
Surgery duration
Time frame: During Surgery
Full mouth plaque Score
Time frame: Baseline 3 6 and 12 months
Full mouth bleeding Score
Time frame: Baseline, 3 6 and 12 month
Wound Healing Index
Time frame: Day 7, week 2 , Week 4 and 3 months
Modified Coronally advanced tunnel Difficulty score (MCATDS) for the treatment of gingival recessions
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Incision Subperiosteal Tunnel Access (VISTA) and Modified Coronally Advanced Tunnel (MCAT) in people with Gingival Recession, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Carrillo de Albornoz Sainz (+34 627588248, acarri02@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Areal Marginal Soft Tissue Thickness (aTHK) (time frame: Baseline, 3, 6 and 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.