Clinical trial NCT03258996: m-VISTA Technique vs. CAF in the Treatment of Class III Multiple Recessions
Official title: Modified VISTA Technique Versus Coronally Advanced Flap in the Treatment of Class III Multiple Recessions: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recessions
Keywords: Gingival recession
Class III gingival recession
Multiples gingival recessions
Periodontitis
Mucogingival surgery
Modified vestibular incision subperiosteal tunnel access
Coronally advanced flap
Connective tissue graft
Post-surgical pain
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will perform the experimental or control technique according to the randomization sequence.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of root coverage (%CR)
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of recessions with complete root coverage (%CRC)
timeFrame: 12 months
measure: Post-surgical pain perception
timeFrame: After surgery up to 14 days
measure: Gingival recession (REC)
timeFrame: Change from baseline at following surgery sixth and twelfth month respectively.
measure: Post-surgical aesthetic result (VAS aesthetic)
timeFrame: 12 months
measure: Pre-surgical pain perception
timeFrame: Baseline.
measure: Post-surgical complications
timeFrame: After surgery first seven days.
measure: Central Sensitization Inventory severity-level score of the subject
timeFrame: Baseline.
measure: Number of recessions to be treated (NRT) Number of recessions to be treated (NRT)
timeFrame: Baseline.
measure: Localization of the recessions to treat (LRT)
timeFrame: Baseline.
measure: Gingival recession width (GRW)
timeFrame: Change from baseline at following surgery sixth and twelfth month respectively.
measure: Keratinized gingiva width (KGW)
timeFrame: Change from baseline at following surgery sixth and twelfth month respectively.
measure: Distance from contact point to the interdental papilla (CP-IP)
timeFrame: Change from baseline at following surgery sixth and twelfth month respectively.
measure: Probing depth (PD)
timeFrame: Change from baseline at following surgery sixth and twelfth month respectively.
measure: Patient bleeding index (BI)
timeFrame: Change from baseline at following surgery sixth and twelfth month respectively.
measure: Patient plaque index (PI)
timeFrame: Change from baseline at following surgery sixth and twelfth month respectively.
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country
state: Biscay
Study officials:
affiliation: University of the Basque Country (UPV/EHU)
name: Luis Antonio Aguirre Zorzano, Dr.
role: STUDY_DIRECTOR
affiliation: University of the Basque Country (UPV/EHU)
name: Aitziber Fernández Jiménez, Lcda.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of the Basque Country (UPV/EHU)
name: Ruth Estefanía Fresco, Dr.
role: STUDY_CHAIR
affiliation: University of the Basque Country (UPV/EHU)
name: Xabier Marichalar Mendia, Dr.
role: STUDY_CHAIR
affiliation: University of the Basque Country (UPV/EHU)
name: Aroa Hereñu González, Lcda.
role: STUDY_CHAIR
affiliation: University of the Basque Country (UPV/EHU)
name: Jose Manuel Aguirre Urizar, Dr.
role: STUDY_DIRECTOR
affiliation: University of the Basque Country (UPV/EHU)
name: Ana María García de la Fuente, Dr.
role: STUDY_CHAIR
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