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

NCT03258996 | Completed DMC

• 1 other identifier: 2017_01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Percentage of root coverage (%CR)

  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 Outcomes (15)

• Percentage of recessions with complete root coverage (%CRC)

  12 months

• Post-surgical pain perception

  After surgery up to 14 days

• Gingival recession (REC)

  Change from baseline at following surgery sixth and twelfth month respectively.

• Post-surgical aesthetic result (VAS aesthetic)

  12 months

• Pre-surgical pain perception

  Baseline.

Study Arms (2)

Modified vestibular incision subperiosteal tunnel access

EXPERIMENTAL

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

Coronally advanced flap

ACTIVE COMPARATOR

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

Interventions

Modified vestibular incision subperiosteal tunnel access 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.

Also known as: m-VISTA

Modified vestibular incision subperiosteal tunnel access

Coronally advanced flap 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.

Also known as: CAF

Coronally advanced flap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aitziber Fernandez Jimenez: lead

Study Sites (1)

Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country

Leioa, Biscay, 48940, Spain

Location

Related Publications (28)

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• Aroca S, Keglevich T, Nikolidakis D, Gera I, Nagy K, Azzi R, Etienne D. Treatment of class III multiple gingival recessions: a randomized-clinical trial. J Clin Periodontol. 2010 Jan;37(1):88-97. doi: 10.1111/j.1600-051X.2009.01492.x. Epub 2009 Nov 30.

  PMID: 19968743 RESULT

• Dandu SR, Murthy KR. Multiple Gingival Recession Defects Treated with Coronally Advanced Flap and Either the VISTA Technique Enhanced with GEM 21S or Periosteal Pedicle Graft: A 9-Month Clinical Study. Int J Periodontics Restorative Dent. 2016 Mar-Apr;36(2):231-7. doi: 10.11607/prd.2533.

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  PMID: 11022782 RESULT

• Fernandez-Jimenez A, Estefania-Fresco R, Garcia-De-La-Fuente AM, Marichalar-Mendia X, Aguirre-Urizar JM, Aguirre-Zorzano LA. Comparative study of the modified VISTA technique (m-VISTA) versus the coronally advanced flap (CAF) in the treatment of multiple Miller class III/RT2 recessions: a randomized clinical trial. Clin Oral Investig. 2023 Feb;27(2):505-517. doi: 10.1007/s00784-022-04746-w. Epub 2022 Oct 20.

  PMID: 36264343 DERIVED

• Fernandez-Jimenez A, Estefania-Fresco R, Garcia-De-La-Fuente AM, Marichalar-Mendia X, Aguirre-Zorzano LA. Description of the modified vestibular incision subperiosteal tunnel access (m-VISTA) technique in the treatment of multiple Miller class III gingival recessions: a case series. BMC Oral Health. 2021 Mar 20;21(1):142. doi: 10.1186/s12903-021-01511-5.

  PMID: 33743644 DERIVED

MeSH Terms

Conditions

Gingival Recession; Periodontitis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Luis Antonio Aguirre Zorzano, Dr.

  University of the Basque Country (UPV/EHU)

  STUDY DIRECTOR

• Aitziber Fernández Jiménez, Lcda.

  University of the Basque Country (UPV/EHU)

  PRINCIPAL INVESTIGATOR

• Ruth Estefanía Fresco, Dr.

  University of the Basque Country (UPV/EHU)

  STUDY CHAIR

• Xabier Marichalar Mendia, Dr.

  University of the Basque Country (UPV/EHU)

  STUDY CHAIR

• Aroa Hereñu González, Lcda.

  University of the Basque Country (UPV/EHU)

  STUDY CHAIR

• Jose Manuel Aguirre Urizar, Dr.

  University of the Basque Country (UPV/EHU)

  STUDY DIRECTOR

• Ana María García de la Fuente, Dr.

  University of the Basque Country (UPV/EHU)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 23, 2017
• Study Start: December 4, 2017
• Primary Completion: March 31, 2021
• Study Completion: September 30, 2021
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)