Xenogeneic Collagen Matrix or Palatal Connective Tissue Graft With a Coronally Advanced Flap in Class III Recessions

NCT03344315 | Completed DMC

• 1 other identifier: 2017_02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this multi-center study is to compare the effectiveness of Mucograft versus connective tissue graft in combination with coronal advanced flap for the treatment of Miller class III recessions The connective tissue graft in combination with coronal advanced flap is considered the gold standard for the treatment of gingival recession in terms of percentage of root coverage and complete root coverage. However connective tissue graft harvesting from the palatal mucosa is often associated with increased patient morbidity, prolonged surgical time and is limited supply. To overcome these inconvenients many efforts are made to develop new materials (healing modifiers, barrier membranes and grafts substitutes) Recently a new two-layer , xenogenic collagen matrix (Mucograft: Geistlich Pharma , Wolhusen Switzerland) has been proposed for regenerative therapy involving teeth and implants. The use of this porcine collagen matrix has obtained promising results for treatment of Miller class I and II recession defects (isolated and multiple recession defects) The mayority of root coverage studies in the literature treats Miller class I and II recession defects .Surgical treatment of class III recesión defects is more challenging due to loss of interproximal bone and soft tissues and complete root coverage may not be expected . But some recent studies demonstrate complete root coverage and high percentage of root coverage in class III recessions. Also a new classification system using the level of interproximal attachment level has been proposed to predict the final root coverage outcome. So ,the soft tissue substitutes should be used also in Miller class III recession, and because of that fact, the investigators are conducting this study, to evaluate the effectiveness of Mucograft in Miller class III recessions compared with connective tissue graft.

Conditions

Gingival Recession

Keywords

Gingival recession; Collagen matrix; Connective tissue graft; Coronally advanced flap; Root coverage; keratinized tissue; Periodontal disease

Outcome Measures

Primary Outcomes (1)

• Percentage of root coverage

  In each patient the mean of their gingival recessions at baseline (initial RECm)and at 6 (RECm 6months)and 12 months (RECm 12 months) will be calculated measuring at the mid buccal point of the involved teeth by the same blinded investigator using the same periodontal probe (PCP SE-11 Hu Friedly, Chicago, IL USA). With this measurements the percentage of root coverage will be calculated

  Change from baseline at following surgery sixth and twelfth month respectively

Secondary Outcomes (8)

• Percentage of recessions with Complete root coverage

  Change from baseline at following surgery sixth and twelfth month respectively

• Patient centred outcomes

  after surgery up to 7 days and 1 year

• Gingival Thickness

  Change from baseline at following surgery and twelfth month respectively

• Keratinized Tissue width

  Change from baseline at following surgery sixth and twelfth month respectively

• Clinical Attachment Level

  Change from baseline at following surgery sixth and twelfth month respectively

Study Arms (2)

autologous connective tissue graft

ACTIVE COMPARATOR

Soft tissue harvesting from patient palate

Other: Active Comparator: autologous connective tissue graft

collagen matrix

EXPERIMENTAL

Mucograft collagen matrix manufactured by Geistlich AG, Switzerland Device: Collagen matrix

Device: experimental: collagen matrix

Interventions

experimental: collagen matrix DEVICE

Mucograft collagen matrix combined with coronal advanced flap

collagen matrix

Active Comparator: autologous connective tissue graft OTHER

Soft tissue harvesting from patient palate with coronal advanced flap

autologous connective tissue graft

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: 18 years to 75 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be 18 years or older
• Patient with one or more recession defects are Miller Class III in incisives, canines and premolars. In at least two quadrants
• Patient shows sufficient plaque control (FMPS \< 20%).
• Treated periodontal conditions
• The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent.

You may not qualify if:

• General contraindications for dental and/or surgical treatment are present.
• The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs).
• Untreated periodontal conditions
• Patients not willing to participate

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead
• Geistlich Pharma AG: collaborator

Study Sites (1)

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

Leioa, Biscay, 48940, Spain

Location

Related Publications (19)

• Buti J, Baccini M, Nieri M, La Marca M, Pini-Prato GP. Bayesian network meta-analysis of root coverage procedures: ranking efficacy and identification of best treatment. J Clin Periodontol. 2013 Apr;40(4):372-86. doi: 10.1111/jcpe.12028. Epub 2013 Jan 24.

  PMID: 23346965 BACKGROUND

• Cairo F, Nieri M, Cincinelli S, Mervelt J, Pagliaro U. The interproximal clinical attachment level to classify gingival recessions and predict root coverage outcomes: an explorative and reliability study. J Clin Periodontol. 2011 Jul;38(7):661-6. doi: 10.1111/j.1600-051X.2011.01732.x. Epub 2011 Apr 20.

  PMID: 21507033 BACKGROUND

• Cairo F, Pagliaro U, Nieri M. Treatment of gingival recession with coronally advanced flap procedures: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):136-62. doi: 10.1111/j.1600-051X.2008.01267.x.

  PMID: 18724847 BACKGROUND

• Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA, Lima LA. Can subepithelial connective tissue grafts be considered the gold standard procedure in the treatment of Miller Class I and II recession-type defects? J Dent. 2008 Sep;36(9):659-71. doi: 10.1016/j.jdent.2008.05.007. Epub 2008 Jun 26.

  PMID: 18584934 BACKGROUND

• Griffin TJ, Cheung WS, Zavras AI, Damoulis PD. Postoperative complications following gingival augmentation procedures. J Periodontol. 2006 Dec;77(12):2070-9. doi: 10.1902/jop.2006.050296.

  PMID: 17209793 BACKGROUND

• Wessel JR, Tatakis DN. Patient outcomes following subepithelial connective tissue graft and free gingival graft procedures. J Periodontol. 2008 Mar;79(3):425-30. doi: 10.1902/jop.2008.070325.

  PMID: 18315424 BACKGROUND

• Esteibar JR, Zorzano LA, Cundin EE, Blanco JD, Medina JR. Complete root coverage of Miller Class III recessions. Int J Periodontics Restorative Dent. 2011 Jul-Aug;31(4):e1-7.

  PMID: 21837295 BACKGROUND

• 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 BACKGROUND

• Sanz M, Lorenzo R, Aranda JJ, Martin C, Orsini M. Clinical evaluation of a new collagen matrix (Mucograft prototype) to enhance the width of keratinized tissue in patients with fixed prosthetic restorations: a randomized prospective clinical trial. J Clin Periodontol. 2009 Oct;36(10):868-76. doi: 10.1111/j.1600-051X.2009.01460.x. Epub 2009 Aug 12.

  PMID: 19678861 BACKGROUND

• Nevins M, Nevins ML, Kim SW, Schupbach P, Kim DM. The use of mucograft collagen matrix to augment the zone of keratinized tissue around teeth: a pilot study. Int J Periodontics Restorative Dent. 2011 Jul-Aug;31(4):367-73.

  PMID: 21837302 BACKGROUND

• Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.

  PMID: 19335093 BACKGROUND

• McGuire MK, Scheyer ET. Long-Term Results Comparing Xenogeneic Collagen Matrix and Autogenous Connective Tissue Grafts With Coronally Advanced Flaps for Treatment of Dehiscence-Type Recession Defects. J Periodontol. 2016 Mar;87(3):221-7. doi: 10.1902/jop.2015.150386. Epub 2015 Oct 15.

  PMID: 26469812 RESULT

• Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial. J Periodontol. 2012 Mar;83(3):321-8. doi: 10.1902/jop.2011.110215. Epub 2011 Jul 1.

  PMID: 21721988 RESULT

• 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 RESULT

• 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 RESULT

• Molnar 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.

  PMID: 23444157 RESULT

• Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Coronally advanced flap with and without a xenogenic collagen matrix in the treatment of multiple recessions: a randomized controlled clinical study. Int J Periodontics Restorative Dent. 2014;34 Suppl 3:s97-102. doi: 10.11607/prd.1605.

  PMID: 24956099 RESULT

• Atieh MA, Alsabeeha N, Tawse-Smith A, Payne AG. Xenogeneic collagen matrix for periodontal plastic surgery procedures: a systematic review and meta-analysis. J Periodontal Res. 2016 Aug;51(4):438-52. doi: 10.1111/jre.12333. Epub 2015 Nov 7.

  PMID: 26547393 RESULT

• Elena RD, Miren VF, Ana-Maria GD, Xabier MM, Luis-Antonio AZ. Analysis of the treatment of RT2 recessions with a xenogeneic collagen matrix vs. connective tissue graft combined with a coronally advanced flap. A double-blinded randomized clinical trial. Clin Oral Investig. 2024 Mar 15;28(4):215. doi: 10.1007/s00784-024-05602-9.

  PMID: 38489063 DERIVED

MeSH Terms

Conditions

Gingival Recession; Periodontal Diseases

Condition Hierarchy (Ancestors)

Gingival Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Luis Antonio Aguirre Zorzano

  University of the Basque Country (UPV/EHU)

  PRINCIPAL INVESTIGATOR

• Elena Ruiz de Gopegui Palacios

  University of the Basque Country (UPV/EHU)

  PRINCIPAL INVESTIGATOR

• Miren Vilor Fernandez

  University of the Basque Country (UPV/EHU)

  STUDY CHAIR

• Ana Garcia de la Fuente

  University of the Basque Country (UPV/EHU)

  STUDY CHAIR

• Ruth Estefania Fresco

  University of the Basque Country (UPV/EHU)

  STUDY CHAIR

• Xavier Marichalar Mendia

  University of the Basque Country (UPV/EHU)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Observer: Another periodoncist outside the intervention, would be in charge of recording the clinical parameters. Analyst: The statistician does not know which treatment corresponds to each variable.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: split mouth

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 17, 2017
• Study Start: March 1, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)