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m-VISTA Technique vs. CAF in ...

m-VISTA Technique vs. CAF in the Treatment of Class III Multiple Recessions

Last Updated: 2022-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-04

Study Completion Date

2021-09-30

Brief Summary

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The main objective is to assess whether the percentage of root coverage (%RC) achieved in the treatment of multiples class III recessions using the technique we have called modified vestibular incision subperiosteal tunnel access (m-VISTA), which is a lateral approach subperiosteal tunnel technique, combined with a connective tissue graft is greater than that achieved through the coronally advance flap (CAF) technique together with a connective tissue graft.

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Detailed Description

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The reason for designing this study is that treatment of Class III gingival recessions (Miller 1985) continues to be challenging today and, although different techniques have been proposed to attempt to improve root coverage results, there is little evidence on what would offer better results.

To achieve those objectives a randomized controlled clinical trial is designed. Using the percentage of root coverage as a primary response variable, it is estimated with the calculation of the sample size, we would need 11 patients for each treatment group (Domenech and Granero 2010). In addition, taking into account possible drop-outs, we would increase the number of patients by recruiting a total of 24 patients.

A same experienced, blind and calibrated (the intraclass correlation coefficient will be at least of 0.75) examiner (R.E.) will collect the following periodontal clinical parameters at the baseline, and at 6 and 12 months, in each tooth involved, using a periodontal probe: Gingival recession, number and location of recessions to be treated, number of treated recessions that have a complete root coverage, the width of the gingival recession and the keratinized gingiva, the distance from the contact point to the interdental papilla, depth of probing, bleeding index and plaque index. And will also collect the opinion of the participant regarding pain and the degree of satisfaction with the aesthetic result.

Students of the University of the Basque Country's (UPV/EHU) Own Degree in Periodontology and Osteointegration will perform the corresponding surgical technique (m-VISTA or CAF) depending on the randomization sequence obtained. A clinical monitor (A.M.G.) will keep the sequence hidden until the moment of the intervention.

Initially, the subject will not know which technique to receive, the complete information regarding the surgical technique used, as the results obtained in his case, will be given in the last visit of the year.

Finally, a blind statistic (X.M) will analyze the data using the SPSS software, having as unit of analysis the subject. Doing a descriptive statistics, checking if the groups are homogeneous in basal, inter-group, intra-group and change variables comparisons and logistical regression to assess the intensity and duration of post-surgical pain adjusted for possible confounding factors.

Conditions

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Gingival Recessions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

We will perform the experimental or control technique according to the randomization sequence.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participant: Initially, the subject will not know what technique has been received, the complete information regarding the surgical technique used, as the results obtained in his case, will be given in the last visit of the year.

Observer: Another periodoncist (R.E.), outside the intervention, would be in charge of recording the clinical parameters.

Analyst: The statistician (X.M.) does not know which treatment corresponds to each variable.

Study Groups

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Modified vestibular incision subperiosteal tunnel access

Test group: Coverage of Class III multiples gingival recessions with the application of Modified vestibular incision subperiosteal tunnel access technique and a connective tissue graft from the palate.

Group Type EXPERIMENTAL

Modified vestibular incision subperiosteal tunnel access

Intervention Type PROCEDURE

Single vertical mucosal incision, in the middel of the area to be treated, from which we began to lift a mucoperiosteal flap in a single plane.

With a micro-scalpel intrasulcular incisions are made extending to the base of the papillas.

Preparation of a tunnel in the same plane. Take a connective tissue graft on the same side of the palate. The connective graft is inserted through the vertical incision prepared with the aid of the suture.

All is stabilized by means of suspensory sutures of coronal traction on each point of contact.

Finally the vertical incision made is sutured.

Coronally advanced flap

Control group: Coverage of Class III multiples gingival recessions with the application of Coronally advanced flap and a connective tissue graft from the palate.

Group Type ACTIVE_COMPARATOR

Coronally advanced flap

Intervention Type PROCEDURE

Oblique submarginal incisions in both interdental areas of each recession, which continue with the intrasulcular incision, one tooth extending on each side of the teeth to be treated.

A partial-total-partial thickness flap is elevated in the coronal-apical direction.

A vestibular mucosal dissection is performed to eliminate muscle tension. The remnant tissue of the anatomical interdental papillas is desepithelized. Take a CTG on the same side of the palate. The connective tissue graft is stabilized with resorbable suture over the recessions with suspensory sutures on the teeth.

Finally, suspensory sutures with non-resorbable sutures are also used to achieve an accurate adaptation of the vestibular flap over the exposed root and stabilize each surgical papilla over each desepithelized interdental area.

Interventions

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Modified vestibular incision subperiosteal tunnel access

Intervention Type PROCEDURE

Coronally advanced flap

Intervention Type PROCEDURE

Other Intervention Names

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m-VISTA CAF

Eligibility Criteria

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Inclusion Criteria

* Patients of the Master of Periodontology of the UPV / EHU.
* Age ≥ 18 years.
* Multiple recessions (more than two) Class III ≥ 2 mm deep, in which the interdental papilla does not extend beyond the cementoenamel line.
* Absence of active periodontal disease.
* Plaque index (O'Leary et al. 1972) and bleeding index (Ainamo and Bay 1975) ≤15%.
* Informed consent.

Exclusion Criteria

* Smokers \> 10 cigarettes / day.
* Subjects with systemic conditions that contraindicate surgery.
* Subjects that have taken analgesics and anti-inflammatory drugs in the last 72 hours.
* Subjects taking opioids, anticonvulsants and antidepressants except serotonin selective inhibitors.
* Women who are pregnant or nursing.
* Patients who do not wish to participate in the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Aitziber Fernandez Jimenez

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR