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

Gingival Recessions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03258996
• Other study ID #: 2017_01
• Status: Completed
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2022
• Source: University of the Basque Country (UPV/EHU)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession
• Gingival Recessions

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country	Leioa	Biscay

Sponsors (1)

Lead Sponsor	Collaborator
Aitziber Fernandez Jimenez

Country where clinical trial is conducted

Spain, 

References & Publications (26)

Agudio G, Nieri M, Rotundo R, Franceschi D, Cortellini P, Pini Prato GP. Periodontal conditions of sites treated with gingival-augmentation surgery compared to untreated contralateral homologous sites: a 10- to 27-year long-term study. J Periodontol. 2009 Sep;80(9):1399-405. doi: 10.1902/jop.2009.090122. — View Citation

Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35. — View Citation

Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. Review. — View Citation

Aroca S, Keglevich T, Barbieri B, Gera I, Etienne D. Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study. J Periodontol. 2009 Feb;80(2):244-52. doi: 10.1902/jop.2009.080253 . — View Citation

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. — View Citation

Aroca S, Molnár B, Windisch P, Gera I, Salvi GE, Nikolidakis D, Sculean A. Treatment of multiple adjacent Miller class I and II gingival recessions with a Modified Coronally Advanced Tunnel (MCAT) technique and a collagen matrix or palatal connective tissue graft: a randomized, controlled clinical trial. J Clin Periodontol. 2013 Jul;40(7):713-20. doi: 10.1111/jcpe.12112. Epub 2013 Apr 30. — View Citation

Butler BL. The subepithelial connective tissue graft with a vestibular releasing incision. J Periodontol. 2003 Jun;74(6):893-8. — View Citation

Carvalho PF, da Silva RC, Cury PR, Joly JC. Modified coronally advanced flap associated with a subepithelial connective tissue graft for the treatment of adjacent multiple gingival recessions. J Periodontol. 2006 Nov;77(11):1901-6. — View Citation

Chatterjee A, Sharma E, Gundanavar G, Subbaiah SK. Treatment of multiple gingival recessions with vista technique: A case series. J Indian Soc Periodontol. 2015 Mar-Apr;19(2):232-5. doi: 10.4103/0972-124X.145836. — View Citation

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( — View Citation

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de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. — View Citation

Del Corso M, Sammartino G, Dohan Ehrenfest DM. Re: "Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study". J Periodontol. 2009 Nov;80(11):1694-7; author reply 1697-9. doi: 10.1902/jop.2009.090253. — View Citation

Kennedy JE, Bird WC, Palcanis KG, Dorfman HS. A longitudinal evaluation of varying widths of attached gingiva. J Clin Periodontol. 1985 Sep;12(8):667-75. — View Citation

Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27. — View Citation

Miller PD Jr. A classification of marginal tissue recession. Int J Periodontics Restorative Dent. 1985;5(2):8-13. — View Citation

Molnár B, Aroca S, Keglevich T, Gera I, Windisch P, Stavropoulos A, Sculean A. Treatment of multiple adjacent Miller Class I and II gingival recessions with collagen matrix and the modified coronally advanced tunnel technique. Quintessence Int. 2013 Jan;44(1):17-24. doi: 10.3290/j.qi.a28739. — View Citation

Müller HP, Eger T, Schorb A. Gingival dimensions after root coverage with free connective tissue grafts. J Clin Periodontol. 1998 May;25(5):424-30. — View Citation

O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. — View Citation

Pini-Prato GP, Cairo F, Nieri M, Franceschi D, Rotundo R, Cortellini P. Coronally advanced flap versus connective tissue graft in the treatment of multiple gingival recessions: a split-mouth study with a 5-year follow-up. J Clin Periodontol. 2010 Jul;37(7):644-50. doi: 10.1111/j.1600-051X.2010.01559.x. Epub 2010 May 11. — View Citation

Santamaria MP, da Silva Feitosa D, Nociti FH Jr, Casati MZ, Sallum AW, Sallum EA. Cervical restoration and the amount of soft tissue coverage achieved by coronally advanced flap: a 2-year follow-up randomized-controlled clinical trial. J Clin Periodontol. 2009 May;36(5):434-41. doi: 10.1111/j.1600-051X.2009.01389.x. — View Citation

Susin C, Haas AN, Oppermann RV, Haugejorden O, Albandar JM. Gingival recession: epidemiology and risk indicators in a representative urban Brazilian population. J Periodontol. 2004 Oct;75(10):1377-86. — View Citation

Tatakis DN, Chambrone L, Allen EP, Langer B, McGuire MK, Richardson CR, Zabalegui I, Zadeh HH. Periodontal soft tissue root coverage procedures: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S52-5. doi: 10.1902/jop.2015.140376. Epub 2014 Oct 15. — View Citation

Wennström JL. Mucogingival therapy. Ann Periodontol. 1996 Nov;1(1):671-701. Review. — View Citation

Zadeh HH. Minimally invasive treatment of maxillary anterior gingival recession defects by vestibular incision subperiosteal tunnel access and platelet-derived growth factor BB. Int J Periodontics Restorative Dent. 2011 Nov-Dec;31(6):653-60. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of recessions with complete root coverage (%CRC)	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
Secondary	Post-surgical pain perception	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
Secondary	Gingival recession (REC)	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.
Secondary	Post-surgical aesthetic result (VAS aesthetic)	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
Secondary	Pre-surgical pain perception	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.
Secondary	Post-surgical complications	The presence or not, as the description, of the post-surgical complications (PSC) that may appear will be collected.	After surgery first seven days.
Secondary	Central Sensitization Inventory severity-level score of the subject	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.
Secondary	Number of recessions to be treated (NRT) Number of recessions to be treated (NRT)	Number of Class III recessions to be treated will be recorded.	Baseline.
Secondary	Localization of the recessions to treat (LRT)	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.
Secondary	Gingival recession width (GRW)	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.
Secondary	Keratinized gingiva width (KGW)	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.
Secondary	Distance from contact point to the interdental papilla (CP-IP)	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.
Secondary	Probing depth (PD)	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.
Secondary	Patient bleeding index (BI)	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.
Secondary	Patient plaque index (PI)	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.