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| Name | Class |
|---|---|
| Geistlich Pharma AG | INDUSTRY |
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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.
Given data reported by the study of Aroca in 2013 ,using the percentage of root coverage as a primary response variable the sample size was estimated in 20 patients. In addition, taking into account possible drop-outs, the investigators would increase the number of patients by 20%, finally recruiting 24 patients per group.
Randomization was performed by computer generated random codes Study locations will include two private centers in Spain. A single calibrated examiner, blind with respect to the treatment assignment, will perform all measurements at all center.
A biostatistician blind with respect to treatment assignment will perform the analysis.
Interventions and Duration The two intervention groups will consist of surgery with connective tissue graft (standard of care control) and surgery with the application of Mucograft Collagen Matrix (MCM, Test group). Experienced clinicians will deliver treatment consisting of root coverage surgery using coronally advanced flaps, the most utilized procedure for coverage of recessions. Surgery will be standardized and the same procedures/materials will be employed to ensure consistency.
Follow-up of individual patients will be 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autologous connective tissue graft | Active Comparator | Soft tissue harvesting from patient palate |
|
| collagen matrix | Experimental | Mucograft collagen matrix manufactured by Geistlich AG, Switzerland Device: Collagen matrix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| experimental: collagen matrix | Device | Mucograft collagen matrix combined with coronal advanced flap |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of recessions with Complete root coverage | The number of recessions which after the treatment show complete root coverage (no recession) measured at the mid buccal point of the involved teeth at baseline and at 6 and 12 months . | Change from baseline at following surgery sixth and twelfth month respectively |
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Inclusion Criteria:
Exclusion Criteria:
18 years to 75 years
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country | Leioa | Biscay | 48940 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23346965 | Background | 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. | |
| 21507033 | 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. |
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The data collected for the study will be identified by a code and only the researcher will be able to relate them. The personal data will be treated with absolute confidentiality in accordance with the Data Protection Law and will remain in the patient's clinical history. The coded data will be included in a UPV/EHU´s file with reference number 2080310015-INA0110, whose head is Ana MarÃa GarcÃa de la Fuente, and will only be used for the purposes of this project.
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split mouth
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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.
| Active Comparator: autologous connective tissue graft | Other | Soft tissue harvesting from patient palate with coronal advanced flap |
|
| Patient centred outcomes |
At suture removal both procedures will be evaluated by the patient for discomfort, duration and difficulty on a visual analogue scale (VAS) . At 12 months the aesthetic outcome obtained with both treatment modalities will be appreciated by the patient on a VAS scale. |
| after surgery up to 7 days and 1 year |
| Gingival Thickness | The thickness in millimeters measured 3mm apically from the free gingival margin at the mid buccal aspect of the tooth | Change from baseline at following surgery and twelfth month respectively |
| Keratinized Tissue width | Distance from the mucogingival junction to the gingival margin | Change from baseline at following surgery sixth and twelfth month respectively |
| Clinical Attachment Level | The gain of clinical attachment level in milimetres, compared with baseline | Change from baseline at following surgery sixth and twelfth month respectively |
| Recession width | Mesio-distal distance taken in the coronal area of the same, measured in millimeters. | Change from baseline at following surgery sixth and twelfth month respectively |
| Aesthetic results | The same blinded investigator will measured the aesthetic result by using the root coverage esthetic score system (RES) | 12 months |
| Time of surgery | At surgery, the length of time of the full procedure will be evaluated (in minutes) | After surgery up to 7 days |
| 18724847 | 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. |
| 18584934 | 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. |
| 17209793 | 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. |
| 18315424 | 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. |
| 21837295 | 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. |
| 19968743 | 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. |
| 19678861 | 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. |
| 21837302 | 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. |
| 19335093 | 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. |
| 26469812 | Result | 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. |
| 21721988 | 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. |
| 23050490 | 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. |
| 23627374 | 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. |
| 23444157 | 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. |
| 24956099 | 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. |
| 26547393 | 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. |
| 38489063 | Derived | 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. |
| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
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