Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT07200258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Changes in Soft Tissue Thickness Following Multiple Coronally Advanced Tunnel (MCAT) vs Vestibular Incision Subperiosteal Tunnel Access (VISTA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2025-07-14', 'studyFirstSubmitQcDate': '2025-09-26', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Areal Marginal Soft Tissue Thickness (aTHK)', 'timeFrame': 'Baseline, 3, 6 and 12 months post-surgery', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Mean Root coverage', 'timeFrame': '3, 6 and 12 months', 'description': 'Percentage of root coverage compared with baseline recession depth. Unit of Measure: % Measurement Tool: UNC-15 periodontal probe'}, {'measure': 'Recession Depth', 'timeFrame': 'Baseline, 3 , 6 and 12 months', 'description': 'Distance from gingival margin to cemento-enamel junction (GM-CEJ). Unit of Measure: mm Measurement Tool: UNC-15 periodontal probe'}, {'measure': 'Probing Pocket Depth', 'timeFrame': 'baseline, 3, 6 and 12 months.', 'description': 'Distance from the gingival margin to the bottom of the sulcus at the mid-buccal site.\n\nUnit of Measure: mm Measurement Tool: UNC-15 periodontal probe'}, {'measure': 'Keratinized tissue Width', 'timeFrame': 'baseline, 3, 6 and 12 months.', 'description': 'Distance from gingival margin to mucogingival junction.\n\nUnit of Measure: mm\n\nMeasurement Tool: UNC-15 periodontal probe'}, {'measure': 'Gingival Thickness', 'timeFrame': 'baseline, 3, 6 and 12 months.', 'description': 'Gingival phenotype assessed by probe transparency.\n\nUnit of Measure: Thick/Thin (categorical)\n\nMeasurement Tool: UNC-15 periodontal probe'}, {'measure': 'Loss of Attachment', 'timeFrame': 'Baseline, 3, 6 and 12 months.', 'description': 'Presence or absence of interproximal clinical attachment loss at treated sites.\n\nUnit of Measure: mm\n\nMeasurement Tool: UNC-15 periodontal probe'}, {'measure': 'Root Coverage Esthetic Score', 'timeFrame': '3 6 and 12 months.', 'description': 'Esthetic evaluation of root coverage outcomes (0-10 composite score).\n\nUnit of Measure: Score (0-10)\n\nMeasurement Tool: RES index (Cairo 2009) from standardized photographs'}, {'measure': 'Dental Hypersensitivity', 'timeFrame': 'baseline, 3, 6 and 12 months', 'description': 'Sensitivity to air stimulus at cervical area.\n\nUnit of Measure: Frequency (%) of teeth with sensitivity\n\nMeasurement Tool: Standardized air-blast test (10 seconds)'}, {'measure': 'Flap Tension', 'timeFrame': 'Baseline', 'description': 'Residual flap tension during coronal advancement.\n\nUnit of Measure: Newtons (N)\n\nMeasurement Tool: Calibrated tension meter (Burkhardt \\& Lang, 2010)'}, {'measure': 'Oral Health Impact Profile', 'timeFrame': 'Baseline, 3 6 and 12 month', 'description': 'Patient-reported outcomes using the OHIP-14 questionnaire.\n\nUnit of Measure: Score (0-56; higher = worse QoL)\n\nMeasurement Tool: Validated Spanish version of OHIP-14'}, {'measure': 'Patients Concerns with recession', 'timeFrame': 'Baseline, 6 and 12 month', 'description': '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.'}, {'measure': 'Time to recovery', 'timeFrame': 'from baseline to 14 days post surgery', 'description': '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.\n\nUnit of Measure: Days\n\nMeasurement Tool: Periodontal Surgery Post-op (PS Postop) diary with VAS (0-10 cm) and Likert scales'}, {'measure': 'Digital recession depth', 'timeFrame': 'Baseline, 3 6 and 12 month', 'description': 'Apico-coronal extension of recession measured digitally.\n\nUnit of Measure: mm\n\nMeasurement Tool: Intraoral scanner (3Shape TRIOS) and Nemotec software'}, {'measure': 'Digital Complete root coverage', 'timeFrame': 'Baseline, 3 6 and 12 month', 'description': 'Whether gingival margin reached/surpassed CEJ.\n\nUnit of Measure: Binary (Yes/No)\n\nMeasurement Tool: Intraoral scanner (3Shape TRIOS) and Nemotec software'}, {'measure': 'Digital Percentage of root coverage', 'timeFrame': 'Baseline, 3 6 and 12 month', 'description': 'Percentage of root coverage compared with baseline, digitally measured.\n\nUnit of Measure: %\n\nMeasurement Tool: Intraoral scanner (3Shape TRIOS) and Nemotec software'}, {'measure': 'Digital Pointwise Marginal Soft Tissue Thickness', 'timeFrame': 'Baseline, 3 6 and 12 month', 'description': 'Gingival thickness at specific points in cross-section.\n\nUnit of Measure: mm\n\nMeasurement Tool: Intraoral scanner (3Shape TRIOS) and Nemotec software'}, {'measure': 'Surgery duration', 'timeFrame': 'During Surgery', 'description': 'Total duration of surgical procedure.\n\nUnit of Measure: Minutes\n\nMeasurement Tool: Stopwatch (recorded intraoperatively)'}, {'measure': 'Full mouth plaque Score', 'timeFrame': 'Baseline 3 6 and 12 months', 'description': '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.'}, {'measure': 'Full mouth bleeding Score', 'timeFrame': 'Baseline, 3 6 and 12 month', 'description': '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.'}, {'measure': 'Wound Healing Index', 'timeFrame': 'Day 7, week 2 , Week 4 and 3 months', 'description': 'Wound healing will be evaluated using a modified semi-quantitative composite index based on the methodology described by Tonetti (Tonetti et al., 2018).\n\nHealing is assessed evaluating four variables.\n\nFlap Margin Assessment\n\nPapillae Evaluation\n\nGraft Site Examination\n\nSuture Evaluation'}, {'measure': 'Modified Coronally advanced tunnel Difficulty score (MCATDS) for the treatment of gingival recessions', 'timeFrame': 'Baseline', 'description': '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.\n\nThe parameters include:\n\n* Tooth position (maxillary vs mandibular)\n* Tooth type (incisor/canine, premolar, molar)\n* Recession type (RT1, RT2, RT3)\n* Recession depth (\\<4 mm vs ≥4 mm)\n* Number of recessions involved (≤2, 3-4, ≥5)\n* Uniformity of recession sizes\n* Baseline keratinized tissue height\n* Gingival biotype (thick vs thin)\n* Frenulum presence and distance to gingival margin\n* Presence of scar tissue\n* Detectability of the cemento-enamel junction (CEJ)\n* Cervical step (\\>0.5 mm)\n* Tooth malposition\n\nEach parameter contributes between 0 and 2 points. The total score ranges from 0 to 17, and difficulty is categorized as:\n\n* Easy (0-5 points): Suitable for novice clinicians\n* Moderate (6-11 points): Requires experienced operators\n* Difficult (12-17 points): Reserved for highly skilled surgeons'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Recession']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThere 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.', 'detailedDescription': 'Parallel group, clinical evaluator and statistician blinded, randomized clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Periodontally and systemically healthy adults (age ≥ 18 years).\n* 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.\n* Presence ≥2 mm depth on at least one recession\n* Smokers ≤ 10 cigarettes.\n* Full-mouth plaque and bleeding scores ≤20%.\n* Patients being able to maintain good oral hygiene.\n\nExclusion Criteria:\n\n* Compromised general health.\n* Pregnancy or attempting to get pregnant (self-reported).\n* Untreated periodontal diseases\n* Presence of: (i) severe tooth malposition; (ii) root caries or inadequate prosthetic restorations; (iii) previous periodontal plastic surgery at the experimental sites.\n* Smokers \\>10 cigarettes'}, 'identificationModule': {'nctId': 'NCT07200258', 'briefTitle': 'Changes in Soft Tissue Thickness Following Multiple Coronally Advanced Tunnel (MCAT) vs Vestibular Incision Subperiosteal Tunnel Access (VISTA)', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'UCM_MCAT-VISTA RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 : Vestibular Incision Subperiosteal Tunnel Access (VISTA)', 'description': '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.', 'interventionNames': ['Procedure: Vestibular Incision Subperiosteal Tunnel Access (VISTA)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 : Modified Coronally Advanced Tunnel Technique (MCAT)', 'interventionNames': ['Procedure: Modified Coronally Advanced Tunnel (MCAT)']}], 'interventions': [{'name': 'Vestibular Incision Subperiosteal Tunnel Access (VISTA)', 'type': 'PROCEDURE', 'description': 'Remote incisions will be performed in the test group. The VISTA technique will be performed as described by Zadeh (Zadeh, 2011).\n\nAfter 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.', 'armGroupLabels': ['Arm 1 : Vestibular Incision Subperiosteal Tunnel Access (VISTA)']}, {'name': 'Modified Coronally Advanced Tunnel (MCAT)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Arm 2 : Modified Coronally Advanced Tunnel Technique (MCAT)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ana Carrillo de Albornoz Sainz', 'role': 'CONTACT', 'email': 'acarri02@ucm.es', 'phone': '+34 627588248'}, {'name': 'Tommaso Conforti', 'role': 'CONTACT', 'email': 'tommconf@ucm.es', 'phone': '+39 3383205344'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}