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

Periodontitis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761668
• Other study ID #: PARO/KFO-15-249
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: March 22, 2023

Study information

• Verified date: March 2023
• Source: University of Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 22, 2023
• Est. primary completion date: July 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Exclusion Criteria: 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

Related Conditions & MeSH terms

• Intrabony Periodontal Defect
• Periodontitis
• Tooth Migration

Intervention

Procedure:
• ParS+Ortho 4W
Orthodontics 4 weeks post surgical
• ParS+Ortho 6M
Orthodontics 6 months post surgical

Locations

Country	Name	City	State
Germany	Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde	Bonn	North Rhine-Westphalia
Spain	Master de Periodoncia Universidad Complutense	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
University of Bonn	Universidad Complutense de Madrid

Countries where clinical trial is conducted

Germany,  Spain, 

References & Publications (17)

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. — View 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. — View Citation

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

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

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. — View 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. — View 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. — View 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. — View 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. — View 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

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. — View 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. — View 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. — View 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. — View 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. — View 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

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.

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment level (CAL) at test site	Clinical attachment level (CAL)measurements 12 months after surgery	12 months
Secondary	Probing depth (PD) at test site	Probing depth (PD) )measurements 12 and 24 months after surgery	24 months
Secondary	Mean probing depth (PD)	Mean probing depth (PD) )measurements 12 and 24 months after surgery	24 months
Secondary	Bleeding on Probing (BoP) at test site	Bleeding on Probing (BoP) measurements 12 and 24 months after surgery	24 months
Secondary	Mean bleeding on Probing (BoP)	Mean Bleeding on Probing (BoP) measurements 12 and 24 months after surgery	24 months
Secondary	Plaque (PI) at test site	Plaque (PI) measurements 12 and 24 months after surgery	24 months
Secondary	Mean Plaque (PI)	Plaque (PI) measurements 12 months after surgery	24 months
Secondary	Mean clinical attachment level (CAL)	Mean clinical attachment level (CAL)12 months after surgery	24 months
Secondary	PROMS	Patient reported Outcomes	24 months