Treatment of Multiple Gingival Recessions With a MCAF or a MCAT and a Collagen Matrix

NCT04225351 | Active Not Recruiting DMC

• 1 other identifier: Fibro-gide 1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

In a recent meta-analysis, Graziani et al. reported that despite the "ideal" treatment for multiple gingival recession defects is not yet identified, there are some indirect suggestions from the analyzed data that, in comparison to the traditional coronally advanced flap (CAF) approach, the use of additional grafting, modifications of the flap technique or tunnel variation with connective tissue graft (CTG) may improve clinical results. Furthermore, various allografts or replacement biomaterials have been developed instead of a connective tissue graft in order to reduce patient morbidity. A newly developed porcine-derived bio-resorbable collagen matrix (CM) (Fibro-Gide) has been recently introduced as an alternative to CTG in periodontal plastic surgery. The aim of this study will be to compare the outcomes of two muco-gingival surgery techniques, the modified coronali advanced flap (MCAF) for multiple recession defects and the modified coronally advanced tunnel technique (MCAT), performed in the Department of Periodontology of San Raffaele Hospital with the results reported in the literature. Secondarily, the study will evaluate whether patients report a preference in terms of discomfort and perception of aesthetics between the two surgical techniques.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• percentage (%) of complete root coverage (CRC)

  Ratio scale - higher values represent a better result

  12 months

Secondary Outcomes (4)

• keratinized tissue width (KTW)

  3, 6 and 12 months

• gingival thickness (GT)

  3, 6 and 12 months

• percentage of root coverage (RC %)

  3, 6 and 12 months

• post-surgical pain (PP),

  1 week after surgery

Study Arms (2)

MCAF+CM

EXPERIMENTAL

Modified coronally advanced flap + collagen matrix

Procedure: MCAF+CM

MCAT+CM

ACTIVE COMPARATOR

Modified coronally advanced tunnel technique + collagen matrix

Procedure: MCAT+CM

Interventions

MCAF+CM PROCEDURE

CAF procedure + collagen matrix

MCAF+CM

MCAT+CM PROCEDURE

Tunnel procedure + collagen matrix

MCAT+CM

Eligibility Criteria

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

You may qualify if:

• multiple (i.e., at least 2) Miller Class I and/or II gingival recessions located in the maxillary, with an apico-coronal extension (i.e., defect depth \> 1 mm with at least one defect \> 2 mm) and with at least 1 mm of residual keratinized tissue,
• good general health, with no systemic diseases that could influence the outcome of the therapy,
• healthy periodontal conditions (i.e., no presence of sites ≥ 4 mm and/or presence of intra-bony defects in the selected sites),
• adequate oral hygiene (full mouth plaque score (FMPS) of \<25% at baseline (following initial oral hygiene instructions and prophylaxis),
• an adequate control of inflammation (full mouth bleeding score \[FMBS\]) of \<25% at baseline (following initial oral hygiene instructions and prophylaxis).

You may not qualify if:

• subjects who currently smoke \>10 cigarettes/day,
• female subjects who are nursing, pregnant, or plan to become pregnant,
• contraindication against oral surgical interventions,
• contraindication against use of Fibro-Gide (acute infection in the area of surgery and patient with collagen allergy)

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead

Study Sites (1)

Ospedale San Raffaele

Milan, Mi, Italy

Location

Related Publications (5)

• Aroca S, Molnar 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.

  PMID: 23627374 BACKGROUND

• Zucchelli G, Mele M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Coronally advanced flap with and without vertical releasing incisions for the treatment of multiple gingival recessions: a comparative controlled randomized clinical trial. J Periodontol. 2009 Jul;80(7):1083-94. doi: 10.1902/jop.2009.090041.

  PMID: 19563288 BACKGROUND

• Jepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B, Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M. Treatment of gingival recession defects with a coronally advanced flap and a xenogeneic collagen matrix: a multicenter randomized clinical trial. J Clin Periodontol. 2013 Jan;40(1):82-9. doi: 10.1111/jcpe.12019. Epub 2012 Oct 10.

  PMID: 23050490 BACKGROUND

• 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.

  PMID: 19186964 BACKGROUND

• Thombre V, Koudale SB, Bhongade ML. Comparative evaluation of the effectiveness of coronally positioned flap with or without acellular dermal matrix allograft in the treatment of multiple marginal gingival recession defects. Int J Periodontics Restorative Dent. 2013 May-Jun;33(3):e88-94. doi: 10.11607/prd.1371.

  PMID: 23593633 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Massimo de Sanctis, MD

  Università Vita-Salute San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: May 12, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)