Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT03533933
Status:
UNKNOWN
Last Update Posted:
2019-07-23
First Post:
2018-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical and Histomorphometric Analysis of Collagen Matrix Versus Connective Tissue Graft in Mucogingival Surgery in Orthodontic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Analyst and Histometry: The statistician and the pathologist does not know which treatment corresponds to each variable.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Split mouth'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-21', 'studyFirstSubmitDate': '2018-05-10', 'studyFirstSubmitQcDate': '2018-05-21', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'millimeters of new attachment', 'timeFrame': 'Change from baseline at following surgery sixth month', 'description': 'histometry assessment'}], 'secondaryOutcomes': [{'measure': 'Length of new cementum', 'timeFrame': 'Change from baseline at following surgery sixth month', 'description': 'histometry assessment'}, {'measure': 'Length of new junctional epithelium', 'timeFrame': 'Change from baseline at following surgery sixth month', 'description': 'histometry assessment'}, {'measure': 'length of connective attachment', 'timeFrame': 'Change from baseline at following surgery sixth month', 'description': 'histometry assessment'}, {'measure': 'complete root coverage', 'timeFrame': 'Change from baseline at following surgery sixth month', 'description': 'clinical assessment'}, {'measure': 'width of keratinized tissue', 'timeFrame': 'Change from baseline at following surgery sixth month', 'description': 'clinical assessment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['collagen matrix', 'connective tissue graft', 'histometry', 'xenograft', 'periodontal regeneration', 'biometry'], 'conditions': ['Gingival Recession']}, 'referencesModule': {'references': [{'pmid': '4529575', 'type': 'BACKGROUND', 'citation': 'Batenhorst KF, Bowers GM, Williams JE Jr. Tissue changes resulting from facial tipping and extrusion of incisors in monkeys. J Periodontol. 1974 Sep;45(9):660-8. doi: 10.1902/jop.1974.45.9.660. No abstract available.'}, {'pmid': '6943326', 'type': 'BACKGROUND', 'citation': 'Steiner GG, Pearson JK, Ainamo J. Changes of the marginal periodontium as a result of labial tooth movement in monkeys. J Periodontol. 1981 Jun;52(6):314-20. doi: 10.1902/jop.1981.52.6.314.'}, {'pmid': '3470318', 'type': 'BACKGROUND', 'citation': 'Wennstrom JL, Lindhe J, Sinclair F, Thilander B. Some periodontal tissue reactions to orthodontic tooth movement in monkeys. J Clin Periodontol. 1987 Mar;14(3):121-9. doi: 10.1111/j.1600-051x.1987.tb00954.x.'}, {'pmid': '23346965', 'type': 'BACKGROUND', 'citation': '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': '18724847', 'type': 'BACKGROUND', 'citation': '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': '18584934', 'type': 'BACKGROUND', 'citation': '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': '19663961', 'type': 'BACKGROUND', 'citation': 'Thoma DS, Benic GI, Zwahlen M, Hammerle CH, Jung RE. A systematic review assessing soft tissue augmentation techniques. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:146-65. doi: 10.1111/j.1600-0501.2009.01784.x.'}, {'pmid': '25123764', 'type': 'BACKGROUND', 'citation': 'Thoma DS, Muhlemann S, Jung RE. Critical soft-tissue dimensions with dental implants and treatment concepts. Periodontol 2000. 2014 Oct;66(1):106-18. doi: 10.1111/prd.12045.'}, {'pmid': '16805692', 'type': 'BACKGROUND', 'citation': 'Soileau KM, Brannon RB. A histologic evaluation of various stages of palatal healing following subepithelial connective tissue grafting procedures: a comparison of eight cases. J Periodontol. 2006 Jul;77(7):1267-73. doi: 10.1902/jop.2006.050129.'}, {'pmid': '17209793', 'type': 'BACKGROUND', 'citation': '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': '18315424', 'type': 'BACKGROUND', 'citation': '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': '21721988', 'type': 'BACKGROUND', 'citation': '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': '23627374', 'type': 'BACKGROUND', 'citation': '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': '23050490', 'type': 'BACKGROUND', 'citation': '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': '23444157', 'type': 'BACKGROUND', 'citation': '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': '24956099', 'type': 'BACKGROUND', 'citation': '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': '26547393', 'type': 'BACKGROUND', 'citation': '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': '26469812', 'type': 'BACKGROUND', 'citation': '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': '10709509', 'type': 'RESULT', 'citation': 'Harris RJ. Successful root coverage: a human histologic evaluation of a case. Int J Periodontics Restorative Dent. 1999 Oct;19(5):439-47.'}, {'pmid': '12956483', 'type': 'RESULT', 'citation': 'Carnio J, Camargo PM, Kenney EB. Root resorption associated with a subepithelial connective tissue graft for root coverage: clinical and histologic report of a case. Int J Periodontics Restorative Dent. 2003 Aug;23(4):391-8.'}, {'pmid': '7558658', 'type': 'RESULT', 'citation': 'Pasquinelli KL. The histology of new attachment utilizing a thick autogenous soft tissue graft in an area of deep recession: a case report. Int J Periodontics Restorative Dent. 1995 Jun;15(3):248-57.'}, {'pmid': '11203564', 'type': 'RESULT', 'citation': 'Bruno JF, Bowers GM. Histology of a human biopsy section following the placement of a subepithelial connective tissue graft. Int J Periodontics Restorative Dent. 2000 Jun;20(3):225-31.'}, {'pmid': '11422587', 'type': 'RESULT', 'citation': 'Goldstein M, Boyan BD, Cochran DL, Schwartz Z. Human histology of new attachment after root coverage using subepithelial connective tissue graft. J Clin Periodontol. 2001 Jul;28(7):657-62. doi: 10.1034/j.1600-051x.2001.028007657.x.'}, {'pmid': '11759874', 'type': 'RESULT', 'citation': 'Majzoub Z, Landi L, Grusovin MG, Cordioli G. Histology of connective tissue graft. A case report. J Periodontol. 2001 Nov;72(11):1607-15. doi: 10.1902/jop.2001.72.11.1607.'}, {'pmid': '27977823', 'type': 'RESULT', 'citation': 'Garcia-De-la-Fuente AM, Aguirre-Zorzano LA, Estefania-Fresco R, Roig Odena L, Aguirre-Urizar JM. Histologic and Clinical Study of Gingival Recession Treated with Subepithelial Connective Tissue Graft: A Case Report. Int J Periodontics Restorative Dent. 2017 Jan/Feb;37(1):89-97. doi: 10.11607/prd.2638.'}, {'pmid': '14514224', 'type': 'RESULT', 'citation': 'McGuire MK, Nunn M. Evaluation of human recession defects treated with coronally advanced flaps and either enamel matrix derivative or connective tissue. Part 1: Comparison of clinical parameters. J Periodontol. 2003 Aug;74(8):1110-25. doi: 10.1902/jop.2003.74.8.1110.'}, {'pmid': '21103645', 'type': 'RESULT', 'citation': 'Roman A, Campian R, Domsa I, Soanca A, Gocan H. Subepithelial connective tissue graft for root coverage: clinical case reports and histologic evaluation. Rom J Morphol Embryol. 2010;51(4):793-7.'}, {'pmid': '9848542', 'type': 'RESULT', 'citation': 'Harris RJ. Root coverage with a connective tissue with partial thickness double pedicle graft and an acellular dermal matrix graft: a clinical and histological evaluation of a case report. J Periodontol. 1998 Nov;69(11):1305-11. doi: 10.1902/jop.1998.69.11.1305.'}]}, 'descriptionModule': {'briefSummary': 'There are some orthodontics treatments that perform risk movements ,and a bone dehiscence may be expected. In that cases mucogingival surgery , such as connective tissue grafts, is necessary prior to tooth movement.\n\nThe connective tissue graft in combination with coronal advanced flap is still considered the gold standard , although the use of porcine collagen matrix has obtained promising results for treatment of Miller class I and II recession defects.\n\nMost of the studies report clinical results after a connective tissue graft and there is no evidence about the type of attachment obtained after the graft is performed, a few articles have shown histological results. But, as a rule , a histological study is only performed under exceptional circumstances such as a dental fracture, untreatable decay, tooth extraction for orthodontic reasons, or other reasons.\n\nMost of the techniques results in the formation of a long junctional epithelium and connective tissue attachment with fibers parallel to the root surface. Animals studies have shown a shorter epithelium and a larger new cementum formation after the use of the collagen matrix.', 'detailedDescription': 'The purpose of this study is to confirm that periodontal regeneration happens after mucogingival surgery The principal outcome is compare the millimeters of new attachment create after a connective tissue graft and after the use of a porcine collagen matrix in teeth that have to been extracted (because of the orthodontic planing treatment) after mucogingival surgery .\n\nThe secondary outcomes are:\n\n1. length of new cementum (histometry results)\n2. length of the junctional epithelium (histometry results)\n3. length of connective tissue attachment (histometry results)\n4. complete root coverage (clinical results)\n5. width of keratinized tissue'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient in orthodontic treatment ,who needs mucogingival surgery in both hemi arcade and later the tooth adjacent to the graft should be extracted because of the orthodontic planing treatment .\n* The patient must be 18 years or older\n* Patient shows sufficient plaque control (FMPS \\< 20%).\n* The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent\n\nExclusion Criteria:\n\n* General contraindications for dental and/or surgical treatment are present.\n* 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).\n* Untreated periodontal conditions\n* Patients not willing to participate'}, 'identificationModule': {'nctId': 'NCT03533933', 'briefTitle': 'Clinical and Histomorphometric Analysis of Collagen Matrix Versus Connective Tissue Graft in Mucogingival Surgery in Orthodontic Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of the Basque Country (UPV/EHU)'}, 'officialTitle': 'Clinical and Histomorphometric Analysis of Collagen Matrix Versus Connective Tissue Graft in Mucogingival Surgery in Orthodontic Patients. A Randomized, Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'MCP-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Autologous connective tissue graft', 'description': 'Soft tissue harvesting from patient palate', 'interventionNames': ['Other: autologous connective tissue graft']}, {'type': 'EXPERIMENTAL', 'label': 'collagen matrix', 'description': 'Mucograft collagen matrix manufactured by Geistlich AG, Switzerland Device: Collagen matrix', 'interventionNames': ['Device: Collagen matrix']}], 'interventions': [{'name': 'Collagen matrix', 'type': 'DEVICE', 'description': 'Mucograft collagen matrix combined with coronal advanced flap', 'armGroupLabels': ['collagen matrix']}, {'name': 'autologous connective tissue graft', 'type': 'OTHER', 'description': 'Soft tissue harvesting from patient palate with coronal advanced flap', 'armGroupLabels': ['Autologous connective tissue graft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48940', 'city': 'Leioa', 'state': 'Biscay', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Elena Ruiz de Gopegui Palacios', 'role': 'CONTACT', 'email': 'helenruizdegopegui@gmail.com', 'phone': '0034649547011'}, {'name': 'Ana Maria Garcia de la Fuente', 'role': 'CONTACT', 'email': 'anamaria.garciad@ehu.es'}, {'name': 'Elena Ruiz de Gopegui Palacios', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ana Maria Garcia de la Fuente', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Luis Antonio Aguirre Zorzano', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ruth Estefanía Fresco', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xavier Marichalar Mendia', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jose Manuel Aguirre Urizar', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country', 'geoPoint': {'lat': 43.32686, 'lon': -2.98884}}], 'centralContacts': [{'name': 'Elena Ruiz de Gopegui', 'role': 'CONTACT', 'email': 'helenruizdegopegui@gmail.com', 'phone': '0034649547011'}, {'name': 'Ana Maria Garcia de la Fuente', 'role': 'CONTACT', 'email': 'anamaria.garciad@ehu.es'}], 'overallOfficials': [{'name': 'Luis Antonio Aguirre Zorzano', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of the Basque Country (UPV/EHU)'}, {'name': 'Elena Ruiz de Gopegui', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of the Basque Country (UPV/EHU)'}, {'name': 'Ana Maria Garcia de la Fuente', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of the Basque Country (UPV/EHU)'}, {'name': 'Ruth Estefania Fresco', 'role': 'STUDY_CHAIR', 'affiliation': 'University of the Basque Country (UPV/EHU)'}, {'name': 'Xavier Marichalar Mendia', 'role': 'STUDY_CHAIR', 'affiliation': 'University of the Basque Country (UPV/EHU)'}, {'name': 'Jose Manuel Aguirre Urizar', 'role': 'STUDY_CHAIR', 'affiliation': 'University of the Basque Country (UPV/EHU)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "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 María García de la Fuente, and will only be used for the purposes of this project."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elena Ruiz de Gopegui Palacios', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Elena Ruiz de Gopegui Palacios', 'investigatorAffiliation': 'University of the Basque Country (UPV/EHU)'}}}}