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| Name | Class |
|---|---|
| Universidad Complutense de Madrid | OTHER |
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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.
There 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.
It 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).
Primary 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ParS+Ortho 4W | Experimental | Orthodontic alignment starts 4 weeks post surgical |
|
| ParS+Ortho 6M | Active Comparator | Orthodontic alignment starts 6 months post surgical |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ParS+Ortho 4W | Procedure | Orthodontics 4 weeks post surgical |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical attachment level (CAL) at test site | Clinical attachment level (CAL)measurements 12 months after surgery | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Probing depth (PD) at test site | Probing depth (PD) )measurements 12 and 24 months after surgery | 24 months |
| Mean probing depth (PD) | Mean probing depth (PD) )measurements 12 and 24 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
Any contraindications for oral surgical procedures
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| Name | Affiliation | Role |
|---|---|---|
| Søren Jepsen, Phd | Director | Study Chair |
| Karin Jepsen, Dr | OA | Principal Investigator |
| Andreas Jaeger, Phd | Director | Study Chair |
| Conchita Martin, PhD | Faculty of Odontology, UCM | Study Chair |
| Mariano Sanz, PhD | Faculty of Odontology, UCM | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poliklinik fĂ¼r Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde | Bonn | North Rhine-Westphalia | 53111 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 4532114 | Background | 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. | |
| 271655 | Background | 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. |
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| ParS+Ortho 6M |
| Procedure |
Orthodontics 6 months post surgical |
|
| 24 months |
| Bleeding on Probing (BoP) at test site | Bleeding on Probing (BoP) measurements 12 and 24 months after surgery | 24 months |
| Mean bleeding on Probing (BoP) | Mean Bleeding on Probing (BoP) measurements 12 and 24 months after surgery | 24 months |
| Plaque (PI) at test site | Plaque (PI) measurements 12 and 24 months after surgery | 24 months |
| Mean Plaque (PI) | Plaque (PI) measurements 12 months after surgery | 24 months |
| Mean clinical attachment level (CAL) | Mean clinical attachment level (CAL)12 months after surgery | 24 months |
| PROMS | Patient reported Outcomes | 24 months |
| Master de Periodoncia Universidad Complutense |
| Madrid |
| 28040 |
| Spain |
| 11203546 | Background | 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. |
| 19146051 | Background | 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. |
| 17243328 | Background | 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. |
| 25909531 | Background | 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. |
| Background | Ghezzi C, ViganĂ² 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 |
| 25867990 | Background | 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. |
| Background | 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. |
| 22479985 | Background | 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. |
| 11142670 | Background | 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. |
| 15948679 | Background | Brunsvold MA. Pathologic tooth migration. J Periodontol. 2005 Jun;76(6):859-66. doi: 10.1902/jop.2005.76.6.859. |
| Background | Cardaropoli D, Gaveglio L, Abou-Arraj RV (2014). Orthodontic movement and periodontal defects: rationale, timing, and clinical implications. Semin Orthod, 20: 177-187. |
| 21777268 | Background | 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. |
| Background | 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 |
| 20629545 | Background | 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. |
| 12019709 | Background | 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. |
| 41074768 | Derived | 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. |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D014085 | Tooth Migration |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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