Gingival RecessionsNCT06755294
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 study testing Vestibular incision subperiostal tunnel technique and CAF in people with Gingival Recessions, run by Universitat Internacional de Catalunya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recessions
- What is being tested?
- Vestibular incision subperiostal tunnel technique and CAF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Gingival Recessions
- Being tested
- Vestibular incision subperiostal tunnel technique, CAF
- Keywords
- VISTA TECHNIQUE, CAF, Root Coverage
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular incision subperiostal tunnel techniqueProcedure or surgery
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.
CAFProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| TEST | Experimental | VISTA TECHNIQUE Receives: Procedure: Vestibular incision subperiostal tunnel technique |
| Control | Experimental | Coronally Advanced Technique Receives: Procedure: CAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession reduction (RR)
Measured with a periodontal probe and with a STL file
Measured: 3 months and 6 months after the surgery
Secondary outcomes (6)
mean root coverage (% RC)
Measured with a periodontal probe and with a STL file
Measured: 3 and 6 months after the surgery
PPD
distance from the gingival margin to the base of the gingival sulcus
Measured: Baseline, 3 and 6 months after the surgery
CAL
distance from the LAC to the base of the gingival sulcus
Measured: Baseline, 3 and 6 months after the surgery
KTW
distance from the gingival margin to the mucogingival line (MGL
Measured: Baseline, 3 and 6 months after the surgery
Gingival thickness
Distance from the most external part of the gingiva to the buccal plate. Measured with a periodontal probe and with a STL file
Measured: Baseline, 3 and 6 months after the surgery
Complete root coverage
Measured with a periodontal probe and with a STL file
Measured: 3 and 6 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start30 Jan 2025 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvaro Babiano Nodal, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755294
- Sponsor's protocol ID
- PER-ECL-2023-09
- Status last verified
- Jan 2025
- First submitted
- 23 Dec 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06755294
- Acronym / sponsor ID
- PER-ECL-2023-09
- Conditions
- Gingival Recessions
- Keywords
- VISTA TECHNIQUE, CAF, Root Coverage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 30 Jan 2025 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEST | Experimental | Procedure: Vestibular incision subperiostal tunnel techniqueVISTA TECHNIQUE |
| Control | Experimental | Procedure: CAFCoronally Advanced Technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (7 listed)
- Smoker of 10 ≥ cigarettes per day.
- Contraindications to periodontal surgery.
- Medications that affect the gingiva or their healing.
- Active orthodontic treatment.
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular incision subperiostal tunnel techniqueThe 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. | Procedure or surgery | TEST |
| CAFThe 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. | Procedure or surgery | Control |
Primary outcome
Recession reduction (RR)
Time frame: 3 months and 6 months after the surgery
Measured with a periodontal probe and with a STL file
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular incision subperiostal tunnel technique and CAF in people with Gingival Recessions, run by Universitat Internacional de Catalunya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alvaro Babiano Nodal, DDS,MSC (680391415, alvarobabianon@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recession reduction (RR) (time frame: 3 months and 6 months after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.