Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Parallel group, clinical evaluator and statistician blinded, randomized clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Arm 2 : Modified Coronally Advanced Tunnel Technique (MCAT) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Root coverage | Percentage of root coverage compared with baseline recession depth. Unit of Measure: % Measurement Tool: UNC-15 periodontal probe | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Carrillo de Albornoz Sainz | Contact | +34 627588248 | acarri02@ucm.es | |
| Tommaso Conforti | Contact | +39 3383205344 | tommconf@ucm.es |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Complutense of Madrid | Recruiting | Madrid | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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 | 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. | 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 | 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 | 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 | 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 | 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 | Baseline, 3 6 and 12 month |
| Surgery duration | Total duration of surgical procedure. Unit of Measure: Minutes Measurement Tool: Stopwatch (recorded intraoperatively) | 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. | 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. | 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 | 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:
Each parameter contributes between 0 and 2 points. The total score ranges from 0 to 17, and difficulty is categorized as:
| Baseline |
| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
Not provided
Not provided