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Not yet recruiting 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

No phase Interventional Gingival Recessions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vestibular incision subperiostal tunnel technique, CAF.
Who it may be relevant to
Registry conditions: Gingival Recessions. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure Vestibular incision subperiostal tunnel 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-epitheliali
  • Procedure CAF
    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 buc

Primary outcome measures

  • Recession reduction (RR) [Time frame: 3 months and 6 months after the surgery]
Secondary outcome measures (6)
  • mean root coverage (% RC) [Time frame: 3 and 6 months after the surgery]
  • PPD [Time frame: Baseline, 3 and 6 months after the surgery]
  • CAL [Time frame: Baseline, 3 and 6 months after the surgery]
  • KTW [Time frame: Baseline, 3 and 6 months after the surgery]
  • Gingival thickness [Time frame: Baseline, 3 and 6 months after the surgery]
  • Complete root coverage [Time frame: 3 and 6 months after the surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06755294 · PER-ECL-2023-09

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗