Timing of Orthodontic Therapy and Regenerative Periodontal Surgery in Advanced Periodontitis Patients With Pathologic Tooth Migration

NCT02761668 | Completed

• 1 other identifier: PARO/KFO-15-249
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Periodontitis; Tooth Migration; Intrabony Periodontal Defect

Keywords

Pathological tooth migration; periodontal regenerative surgery; vertical infrabony defects; xenogeneic bone graft; orthodontic therapy

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level (CAL) at test site

  Clinical attachment level (CAL)measurements 12 months after surgery

  12 months

Secondary Outcomes (8)

• Probing depth (PD) at test site

  24 months

• Mean probing depth (PD)

  24 months

• Bleeding on Probing (BoP) at test site

  24 months

• Mean bleeding on Probing (BoP)

  24 months

• Plaque (PI) at test site

  24 months

Study Arms (2)

ParS+Ortho 4W

EXPERIMENTAL

Orthodontic alignment starts 4 weeks post surgical

Procedure: ParS+Ortho 4W

ParS+Ortho 6M

ACTIVE COMPARATOR

Orthodontic alignment starts 6 months post surgical

Procedure: ParS+Ortho 6M

Interventions

ParS+Ortho 4W PROCEDURE

Orthodontics 4 weeks post surgical

ParS+Ortho 4W

ParS+Ortho 6M PROCEDURE

Orthodontics 6 months post surgical

ParS+Ortho 6M

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced periodontitis
• 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
• Pathologic tooth migration
• Full mouth plaque index (PI) \<25% at baseline (after initial non-surgical periodontal therapy)
• Full mouth bleeding on probing (FMBP) \<25% at baseline (i.e., following initial non-surgical periodontal therapy)
• Committed to the study and the required follow-up visits

You may not qualify if:

• Any contraindications for oral surgical procedures
• Uncontrolled diabetes or other uncontrolled systemic diseases
• Disorders or treatments that compromise wound healing
• Medical conditions requiring chronic high dose steroid therapy
• Bone metabolic diseases
• Radiation or other immuno-suppressive therapy
• Infections or vascular impairment at the surgical site
• Presence of oral lesions (such as ulceration, malignancy) or mucosal diseases
• History of malignant disease in the oral cavity or previous radiotherapy to the head
• Inadequate oral hygiene or unmotivated for adequate home care
• Current smokers \> 6Cig

Sponsors & Collaborators

• University of Bonn: lead
• Universidad Complutense de Madrid: collaborator

Study Sites (2)

Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde

Bonn, North Rhine-Westphalia, 53111, Germany

Location

Master de Periodoncia Universidad Complutense

Madrid, 28040, Spain

Location

Related Publications (18)

• 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: 4532114 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.

  PMID: 271655 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.

  PMID: 11203546 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.

  PMID: 19146051 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.

  PMID: 17243328 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.

  PMID: 25909531 BACKGROUND

• 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

  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.

  PMID: 25867990 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.

  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.

  PMID: 22479985 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.

  PMID: 11142670 BACKGROUND

• Brunsvold MA. Pathologic tooth migration. J Periodontol. 2005 Jun;76(6):859-66. doi: 10.1902/jop.2005.76.6.859.

  PMID: 15948679 BACKGROUND

• Cardaropoli D, Gaveglio L, Abou-Arraj RV (2014). Orthodontic movement and periodontal defects: rationale, timing, and clinical implications. Semin Orthod, 20: 177-187.

  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.

  PMID: 21777268 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

  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.

  PMID: 20629545 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.

  PMID: 12019709 BACKGROUND

• 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.

  PMID: 41074768 DERIVED

MeSH Terms

Conditions

Periodontitis; Tooth Migration

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 30, 2016
• First Posted: May 4, 2016
• Study Start: October 1, 2016
• Primary Completion: July 22, 2020
• Study Completion: March 22, 2023
• Last Updated: March 30, 2023

Record last verified: 2023-03

Locations

DE (1); ES (1)