- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06755294
Vestibular Incision Subperiosteal Tunnel Access (VISTA) Technique Versus Coronally Advanced Flap (CAF) Combined With a Connective Tissue Graft for the Treatment of Maxillary Gingival Recessions
Vestibular Incision Subperiosteal Tunnel Access (VISTA) Technique Versus Coronally Advanced Flap (CAF) Combined With a Connective Tissue Graft for the Treatment of Maxillary Gingival Recessions: a Randomized Clinical Trial
Gingival recession (GR) is a common oral health problem that causes sensitivity, esthetic concerns and hygiene problems. Successful root coverage can be achieved by various surgical techniques. The VISTA technique may overcome some of the limitations of other techniques and present equal results to techniques that are considered the "Gold Standard" in this area of periodontology.
The objective of the research is to study the VISTA technique in terms of complete root coverage, % root coverage, gingival thickness gain, bleeding on probing, keratinized gingival width, PROMS, vestibular depth and esthetic results.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alvaro Babiano Nodal, DDS,MSC
- Phone Number: 680391415
- Email: alvarobabianon@uic.es
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy adults: men and women between 18 and 75 years of age.
- Accepts and signs informed consent.
- Systemically healthy patients with periodontal health or controlled periodontitis.
- Presence of at least two maxillary Cairo Type I or II (RT1/2) recessions > 2 mm deep on buccal aspect.
- Plaque index ≤20%
- No previous periodontal surgeries performed.
- Presence of the cementoenamel junction (CEJ), a 1 mm step in the CEJ and/or presence of root abrasion, but with an identifiable CEJ will be accepted.
Exclusion Criteria:
- Smoker of 10 ≥ cigarettes per day.
- Contraindications to periodontal surgery.
- Medications that affect the gingiva or their healing.
- Active orthodontic treatment.
- Pregnant women
- Caries or restorations in the area to be treated.
- Patients who cannot follow the post-surgical medication adequately
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TEST
VISTA TECHNIQUE
|
The VISTA (Vestibular Incision Subperiosteal Tunnel Access) technique is a minimally invasive surgical approach for root coverage. A single vertical incision is made, often at the labial frenulum for optimal access, reaching the periosteum to elevate a subperiosteal tunnel. This tunnel is extended beyond the mucogingival junction and interproximally under each papilla to enable tension-free coronal repositioning of the gingiva. An autologous connective tissue graft, harvested and de-epithelialized from the palate, is introduced into the tunnel. Before placement, teeth are etched (orthophosphoric or hydrofluoric acid depending on surface type). Sutures (6-0 polypropylene) stabilize the graft, with additional composite fixation on treated teeth. The vertical incision is closed using 5-0 sutures, ensuring proper stabilization and healing. This approach minimizes trauma, promotes healing, and achieves effective root coverage. |
|
Experimental: Control
Coronally Advanced Technique
|
The Coronally Advanced Flap (CAF) is an effective technique for root coverage in single or multiple gingival recession cases with adequate apical keratinized tissue thickness and height. Following the De Sanctis and Zucchelli protocol (2007), two horizontal incisions are made 3 mm apart, with placement 1 mm apical to the recession height. Vertical beveled incisions extend into the alveolar mucosa, and a flap is elevated in three stages: partial thickness at the papilla, full thickness to the buccal bone table, and apical partial thickness to release muscle fibers for mobility. An autologous connective tissue graft (≥1 mm thick) is harvested from the palatal or retromolar area, de-epithelialized, and shaped to the recession size. The anatomical papillae are de-epithelialized, and the graft is sutured apically to the CEJ using 6-0 Polyglactin 910. Sling sutures (6-0 polypropylene) stabilize the flap 2 mm coronally to the CEJ, ensuring optimal positioning and healing. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recession reduction (RR)
Time Frame: 3 months and 6 months after the surgery
|
Measured with a periodontal probe and with a STL file
|
3 months and 6 months after the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PPD
Time Frame: Baseline, 3 and 6 months after the surgery
|
distance from the gingival margin to the base of the gingival sulcus
|
Baseline, 3 and 6 months after the surgery
|
|
CAL
Time Frame: Baseline, 3 and 6 months after the surgery
|
distance from the LAC to the base of the gingival sulcus
|
Baseline, 3 and 6 months after the surgery
|
|
KTW
Time Frame: Baseline, 3 and 6 months after the surgery
|
distance from the gingival margin to the mucogingival line (MGL
|
Baseline, 3 and 6 months after the surgery
|
|
mean root coverage (% RC)
Time Frame: 3 and 6 months after the surgery
|
Measured with a periodontal probe and with a STL file
|
3 and 6 months after the surgery
|
|
Gingival thickness
Time Frame: Baseline, 3 and 6 months after the surgery
|
Distance from the most external part of the gingiva to the buccal plate.
Measured with a periodontal probe and with a STL file
|
Baseline, 3 and 6 months after the surgery
|
|
Complete root coverage
Time Frame: 3 and 6 months after the surgery
|
Measured with a periodontal probe and with a STL file
|
3 and 6 months after the surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PER-ECL-2023-09
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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