Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-02-22 @ 5:23 PM
Study NCT ID:
NCT02761668
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2016-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Timing of Orthodontic Therapy and Regenerative Periodontal Surgery in Advanced Periodontitis Patients With Pathologic Tooth Migration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D014085', 'term': 'Tooth Migration'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2016-04-30', 'studyFirstSubmitQcDate': '2016-05-01', 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical attachment level (CAL) at test site', 'timeFrame': '12 months', 'description': 'Clinical attachment level (CAL)measurements 12 months after surgery'}], 'secondaryOutcomes': [{'measure': 'Probing depth (PD) at test site', 'timeFrame': '24 months', 'description': 'Probing depth (PD) )measurements 12 and 24 months after surgery'}, {'measure': 'Mean probing depth (PD)', 'timeFrame': '24 months', 'description': 'Mean probing depth (PD) )measurements 12 and 24 months after surgery'}, {'measure': 'Bleeding on Probing (BoP) at test site', 'timeFrame': '24 months', 'description': 'Bleeding on Probing (BoP) measurements 12 and 24 months after surgery'}, {'measure': 'Mean bleeding on Probing (BoP)', 'timeFrame': '24 months', 'description': 'Mean Bleeding on Probing (BoP) measurements 12 and 24 months after surgery'}, {'measure': 'Plaque (PI) at test site', 'timeFrame': '24 months', 'description': 'Plaque (PI) measurements 12 and 24 months after surgery'}, {'measure': 'Mean Plaque (PI)', 'timeFrame': '24 months', 'description': 'Plaque (PI) measurements 12 months after surgery'}, {'measure': 'Mean clinical attachment level (CAL)', 'timeFrame': '24 months', 'description': 'Mean clinical attachment level (CAL)12 months after surgery'}, {'measure': 'PROMS', 'timeFrame': '24 months', 'description': 'Patient reported Outcomes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pathological tooth migration', 'periodontal regenerative surgery', 'vertical infrabony defects', 'xenogeneic bone graft', 'orthodontic therapy'], 'conditions': ['Periodontitis', 'Tooth Migration', 'Intrabony Periodontal Defect']}, 'referencesModule': {'references': [{'pmid': '4532114', 'type': 'BACKGROUND', 'citation': 'Lindhe J, Svanberg G. Influence of trauma from occlusion on progression of experimental periodontitis in the beagle dog. J Clin Periodontol. 1974;1(1):3-14. doi: 10.1111/j.1600-051x.1974.tb01234.x. No abstract available.'}, {'pmid': '271655', 'type': 'BACKGROUND', 'citation': 'Ericsson I, Thilander B, Lindhe J, Okamoto H. The effect of orthodontic tilting movements on the periodontal tissues of infected and non-infected dentitions in dogs. J Clin Periodontol. 1977 Nov;4(4):278-93. doi: 10.1111/j.1600-051x.1977.tb01900.x. No abstract available.'}, {'pmid': '11203546', 'type': 'BACKGROUND', 'citation': 'Re S, Corrente G, Abundo R, Cardaropoli D. Orthodontic treatment in periodontally compromised patients: 12-year report. Int J Periodontics Restorative Dent. 2000 Feb;20(1):31-9.'}, {'pmid': '19146051', 'type': 'BACKGROUND', 'citation': 'Ghezzi C, Masiero S, Silvestri M, Zanotti G, Rasperini G. Orthodontic treatment of periodontally involved teeth after tissue regeneration. Int J Periodontics Restorative Dent. 2008 Dec;28(6):559-67.'}, {'pmid': '17243328', 'type': 'BACKGROUND', 'citation': 'Cardaropoli D, Re S, Manuzzi W, Gaveglio L, Cardaropoli G. Bio-Oss collagen and orthodontic movement for the treatment of infrabony defects in the esthetic zone. Int J Periodontics Restorative Dent. 2006 Dec;26(6):553-9.'}, {'pmid': '25909531', 'type': 'BACKGROUND', 'citation': 'Jepsen K, Jaeger A, Jepsen S. Esthetic and functional rehabilitation of a severely compromised central incisor: an interdisciplinary approach. Int J Periodontics Restorative Dent. 2015 May-Jun;35(3):e35-43. doi: 10.11607/prd.2345.'}, {'type': 'BACKGROUND', 'citation': 'Ghezzi C, Viganò VM, Francinetti P, Zanotti G, Masiero S. Orthodontic treatment after induced periodontal regeneration in deep infrabony defects. Clinical Advances in Periodontics 2013; 3(1), 24-31'}, {'pmid': '25867990', 'type': 'BACKGROUND', 'citation': 'Cortellini P, Tonetti MS. Clinical concepts for regenerative therapy in intrabony defects. Periodontol 2000. 2015 Jun;68(1):282-307. doi: 10.1111/prd.12048.'}, {'type': 'BACKGROUND', 'citation': 'Tietmann C, Bröseler F, Axelrad T, Jepsen S. Regenerative procedures and orthodontics in the treatment of severe intrabony defects. A retrospective clinical cohort study. Int Poster J Dent Oral Med 2013; 15 Suppl. Poster 690.'}, {'pmid': '22479985', 'type': 'BACKGROUND', 'citation': 'Attia MS, Shoreibah EA, Ibrahim SA, Nassar HA. Regenerative therapy of osseous defects combined with orthodontic tooth movement. J Int Acad Periodontol. 2012 Jan;14(1):17-25.'}, {'pmid': '11142670', 'type': 'BACKGROUND', 'citation': 'Araujo MG, Carmagnola D, Berglundh T, Thilander B, Lindhe J. Orthodontic movement in bone defects augmented with Bio-Oss. An experimental study in dogs. J Clin Periodontol. 2001 Jan;28(1):73-80. doi: 10.1034/j.1600-051x.2001.280111.x.'}, {'pmid': '15948679', 'type': 'BACKGROUND', 'citation': 'Brunsvold MA. Pathologic tooth migration. J Periodontol. 2005 Jun;76(6):859-66. doi: 10.1902/jop.2005.76.6.859.'}, {'type': 'BACKGROUND', 'citation': 'Cardaropoli D, Gaveglio L, Abou-Arraj RV (2014). Orthodontic movement and periodontal defects: rationale, timing, and clinical implications. Semin Orthod, 20: 177-187.'}, {'pmid': '21777268', 'type': 'BACKGROUND', 'citation': 'Cortellini P, Stalpers G, Mollo A, Tonetti MS. Periodontal regeneration versus extraction and prosthetic replacement of teeth severely compromised by attachment loss to the apex: 5-year results of an ongoing randomized clinical trial. J Clin Periodontol. 2011 Oct;38(10):915-24. doi: 10.1111/j.1600-051X.2011.01768.x. Epub 2011 Jul 21.'}, {'type': 'BACKGROUND', 'citation': 'Sanz M, Martin C (2015). Tooth movement in the periodontally compromised patient. In: Clinical periodontology and implant dentistry. Eds: Niklaus P. Lang, Jan Lindhe, pp1297-1324, Wiley'}, {'pmid': '20629545', 'type': 'BACKGROUND', 'citation': 'Ogihara S, Wang HL. Periodontal regeneration with or without limited orthodontics for the treatment of 2- or 3-wall infrabony defects. J Periodontol. 2010 Dec;81(12):1734-42. doi: 10.1902/jop.2010.100127. Epub 2010 Jul 14.'}, {'pmid': '12019709', 'type': 'BACKGROUND', 'citation': 'Re S, Corrente G, Abundo R, Cardaropoli D. Orthodontic movement into bone defects augmented with bovine bone mineral and fibrin sealer: a reentry case report. Int J Periodontics Restorative Dent. 2002 Apr;22(2):138-45.'}, {'pmid': '41074768', 'type': 'DERIVED', 'citation': 'Martin C, Tietmann C, Wenzel S, Luengo M, Gaveglio L, Cardaropoli D, Kutschera E, Sanz-Sanchez I, Wullenweber P, Jepsen S, Jepsen K. RCT on orthodontic timing post-periodontal regeneration: root resorption and tooth movement outcomes. Eur J Orthod. 2025 Sep 17;47(5):cjaf078. doi: 10.1093/ejo/cjaf078.'}]}, 'descriptionModule': {'briefSummary': 'Pathologic tooth migration (PTM) is a common complication of advanced periodontitis and often motivation for patients to seek orthodontic therapy. An interdisciplinary approach is required to control the periodontal infection, reconstruct the defects and realign the migrated teeth. The optimal timing of active orthodontics after regenerative therapy is a topic of ongoing debate.\n\nThere are no data available from RCTs that have compared the effect of the timing of orthodontic tooth movement (early vs. late) on the outcomes of regenerative periodontal surgery in these patients.\n\nIt is the aim of the present randomized clinical multicenter trial to compare 2 different treatment protocols of a combined perio-regenerative and orthodontic therapy in advanced periodontitis patients with intrabony defects and pathologic tooth migration in order to establish whether one treatment modality is superior to the other with regard to clinical outcomes. A total of 46 patients will be enrolled and randomized into 2 treatment groups that differ by the time point of initiation of orthodontic therapy (early: 4 weeks vs. late: 6 months following regenerative periodontal surgery).\n\nPrimary outcome measure will be the change in clinical attachment level (CAL gain) at 12 months after regenerative therapy. Secondary outcomes will include changes in probing depth BOP, gingival recession, radiographic bone height and patient-centered outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced periodontitis\n* Presence of intrabony defects at a minimum of 2 and a maximum of 7 adjacent teeth (positions 15-25 or 35-45) in either the maxilla or the mandible with PPD of ≥6 mm at a minimum on one site\n* Pathologic tooth migration\n* Full mouth plaque index (PI) \\<25% at baseline (after initial non-surgical periodontal therapy)\n* Full mouth bleeding on probing (FMBP) \\<25% at baseline (i.e., following initial non-surgical periodontal therapy)\n* Committed to the study and the required follow-up visits\n\nExclusion Criteria:\n\nAny contraindications for oral surgical procedures\n\n* Uncontrolled diabetes or other uncontrolled systemic diseases\n* Disorders or treatments that compromise wound healing\n* Medical conditions requiring chronic high dose steroid therapy\n* Bone metabolic diseases\n* Radiation or other immuno-suppressive therapy\n* Infections or vascular impairment at the surgical site\n* Presence of oral lesions (such as ulceration, malignancy) or mucosal diseases\n* History of malignant disease in the oral cavity or previous radiotherapy to the head\n* Inadequate oral hygiene or unmotivated for adequate home care\n* Current smokers \\> 6Cig'}, 'identificationModule': {'nctId': 'NCT02761668', 'briefTitle': 'Timing of Orthodontic Therapy and Regenerative Periodontal Surgery in Advanced Periodontitis Patients With Pathologic Tooth Migration', 'organization': {'class': 'OTHER', 'fullName': 'University of Bonn'}, 'officialTitle': 'The Effect of Timing of Orthodontic Therapy on the Outcomes of Regenerative Periodontal Surgery in Patients With Advanced Periodontitis and Pathologic Tooth Migration. A Multi Centre Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'PARO/KFO-15-249'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ParS+Ortho 4W', 'description': 'Orthodontic alignment starts 4 weeks post surgical', 'interventionNames': ['Procedure: ParS+Ortho 4W']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ParS+Ortho 6M', 'description': 'Orthodontic alignment starts 6 months post surgical', 'interventionNames': ['Procedure: ParS+Ortho 6M']}], 'interventions': [{'name': 'ParS+Ortho 4W', 'type': 'PROCEDURE', 'description': 'Orthodontics 4 weeks post surgical', 'armGroupLabels': ['ParS+Ortho 4W']}, {'name': 'ParS+Ortho 6M', 'type': 'PROCEDURE', 'description': 'Orthodontics 6 months post surgical', 'armGroupLabels': ['ParS+Ortho 6M']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53111', 'city': 'Bonn', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Master de Periodoncia Universidad Complutense', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Søren Jepsen, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Director'}, {'name': 'Karin Jepsen, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OA'}, {'name': 'Andreas Jaeger, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Director'}, {'name': 'Conchita Martin, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Odontology, UCM'}, {'name': 'Mariano Sanz, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Odontology, UCM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bonn', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Karin Jepsen', 'investigatorAffiliation': 'University of Bonn'}}}}