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

March 7, 2022 updated by: Aitziber Fernandez Jimenez

Modified VISTA Technique Versus Coronally Advanced Flap in the Treatment of Class III Multiple Recessions: Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Biscay
      • Leioa, Biscay, Spain, 48940
        • Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: 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.
Procedure: Modified vestibular incision subperiosteal tunnel access

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.

Other Names:
  • m-VISTA
Active Comparator: 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.
Procedure: Coronally advanced flap

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.

Other Names:
  • CAF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of root coverage (%CR)
Time Frame: 12 months
In each patient the mean of their gingival recessions at baseline (initial RECm) and at 12 months (RECm_12 months) will be calculated. A new variable called %CR [(RECm_initial - RECm_12 months) / (RECm_initial x 100) will be calculated.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of recessions with complete root coverage (%CRC)
Time Frame: 12 months
Each patient will record the number of recessions, which after treatment, show complete root coverage at 12 months (CRC_12 months). A new variable called % CRC_12 months [CRC_12meses / NRT x100] will be calculated.
12 months
Post-surgical pain perception
Time Frame: After surgery up to 14 days
The subject will we instructed to collect their perception of post-surgical pain in the VAS based Journal of Pain (IDT). Specifically the subject will record: Its intensity (0-100mm), its duration (minutes or hours) and if any analgesic treatment has been necessary (No o Yes: Which?).
After surgery up to 14 days
Gingival recession (REC)
Time Frame: Change from baseline at following surgery sixth and twelfth month respectively.
Distance in mm from the amelocementaria line the gingival margin, measured at the vestibular midpoint. It will be registered in all the teeth present (except wisdom teeth) at the beginning, and, during the follow-up only in the recessions to be treated.
Change from baseline at following surgery sixth and twelfth month respectively.
Post-surgical aesthetic result (VAS aesthetic)
Time Frame: 12 months
The same examiner will evaluate the degree of satisfaction of the subject with the aesthetic result obtained after the intervention, through a Questionnaire based on the Visual Analogue Scale (VAS).
12 months
Pre-surgical pain perception
Time Frame: Baseline.
In the VAS based Journal of Pain (IDT) the examiner will record if the subject has had regional head and neck pain in the last month and if there is any pain in the immediate preoperative, if it is affirmative the intensity will be noted.
Baseline.
Post-surgical complications
Time Frame: After surgery first seven days.
The presence or not, as the description, of the post-surgical complications (PSC) that may appear will be collected.
After surgery first seven days.
Central Sensitization Inventory severity-level score of the subject
Time Frame: Baseline.
Central Sensitization inventory (CSI) (Mayer et al. 2012) will be done, in which each subject will be asked on the frequency in which he perceives 25 symptoms and will be given a score of 0-4 finally establishing a clinical level in a range of 0-100 points (Subclinical: 0-29; Medium: 30-39; Moderate: 40-49 ; Severe: 50-59; Extreme: 60-100).
Baseline.
Number of recessions to be treated (NRT) Number of recessions to be treated (NRT)
Time Frame: Baseline.
Number of Class III recessions to be treated will be recorded.
Baseline.
Localization of the recessions to treat (LRT)
Time Frame: Baseline.
On the one hand, upper recessions will be considered the located in the maxillary and on the other hand, lower recessions those located in the mandible.
Baseline.
Gingival recession width (GRW)
Time Frame: Change from baseline at following surgery sixth and twelfth month respectively.
Mesio-distal distance taken in the coronal area of the same, measured in millimeters. It will be recorded only in the recessions to be treated.
Change from baseline at following surgery sixth and twelfth month respectively.
Keratinized gingiva width (KGW)
Time Frame: Change from baseline at following surgery sixth and twelfth month respectively.
Distance in millimeters from the mucogingival junction to the gingival margin, measured at the vestibular midpoint. It will be recorded only in the recessions to be treated.
Change from baseline at following surgery sixth and twelfth month respectively.
Distance from contact point to the interdental papilla (CP-IP)
Time Frame: Change from baseline at following surgery sixth and twelfth month respectively.
Distance in millimeters from the mesial and distal contact point of the tooth with recession, to the most coronal part of the interdental papilla. It will be recorded only in the recessions to be treated.
Change from baseline at following surgery sixth and twelfth month respectively.
Probing depth (PD)
Time Frame: Change from baseline at following surgery sixth and twelfth month respectively.
Distance in millimeters from the gingival margin to the bottom of the periodontal pocket. It will be recorded at the beginning in all teeth present (except wisdow teeth) in 6 points per tooth (mesio-bucal, mid-bucal, disto-bucal, mesio-lingual, mid-lingual and disto-lingual) and, during follow-up, only in the recessions to be treated at the vestibular mid-point.
Change from baseline at following surgery sixth and twelfth month respectively.
Patient bleeding index (BI)
Time Frame: Change from baseline at following surgery sixth and twelfth month respectively.
After a periodontal probing of all teeth, the presence (yes or no) of bleeding is recorded dichotomously at 6 points per tooth (mesio-bucal, mid-bucal, disto-bucal, mesio-lingual, mid-lingual and disto-lingual) and the percentage of sites that bleed from the total of probed sites is calculated (Ainamo and Bay 1975).
Change from baseline at following surgery sixth and twelfth month respectively.
Patient plaque index (PI)
Time Frame: Change from baseline at following surgery sixth and twelfth month respectively.
A plaque developer is used and the presence (yes or no) of plaque is recorded dichotomously at 6 points per tooth (mesio-bucal, mid-bucal, disto-bucal, mesio-lingual, mid-lingual and disto-lingual) and the percentage of sites with plaque of the total probed sites is calculated (O'Leary et al 1972).
Change from baseline at following surgery sixth and twelfth month respectively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aitziber Fernandez Jimenez

Investigators

  • Principal Investigator: Aitziber Fernández Jiménez, Lcda., University of the Basque Country (UPV/EHU)
  • Study Chair: Aroa Hereñu González, Lcda., University of the Basque Country (UPV/EHU)
  • Study Director: Jose Manuel Aguirre Urizar, Dr., University of the Basque Country (UPV/EHU)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2017

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

August 18, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data collected for the study will be identified by a code and only the researcher will be able to relate them. The personal data will be treated with absolute confidentiality in accordance with the Data Protection Law and will remain in the patient's clinical history. The coded data will be included in a UPV/EHU´s file with reference number 2080310015-INA0110, whose head is Ana María García de la Fuente, and will only be used for the purposes of this project.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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