NCT06755294

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Jan 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Jan 2025Jun 2026

First Submitted

Initial submission to the registry

December 23, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

January 30, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Expected
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

December 23, 2024

Last Update Submit

January 25, 2025

Conditions

Keywords

VISTA TECHNIQUECAFRoot Coverage

Outcome Measures

Primary Outcomes (1)

  • Recession reduction (RR)

    Measured with a periodontal probe and with a STL file

    3 months and 6 months after the surgery

Secondary Outcomes (6)

  • mean root coverage (% RC)

    3 and 6 months after the surgery

  • PPD

    Baseline, 3 and 6 months after the surgery

  • CAL

    Baseline, 3 and 6 months after the surgery

  • KTW

    Baseline, 3 and 6 months after the surgery

  • Gingival thickness

    Baseline, 3 and 6 months after the surgery

  • +1 more secondary outcomes

Study Arms (2)

TEST

EXPERIMENTAL

VISTA TECHNIQUE

Procedure: Vestibular incision subperiostal tunnel technique

Control

EXPERIMENTAL

Coronally Advanced Technique

Procedure: CAF

Interventions

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.

TEST
CAFPROCEDURE

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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Central Study Contacts

Alvaro Babiano Nodal, DDS,MSC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS/MsC

Study Record Dates

First Submitted

December 23, 2024

First Posted

January 1, 2025

Study Start

January 30, 2025

Primary Completion

January 15, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

January 28, 2025

Record last verified: 2025-01