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

Not Applicable

Completed

• Conditions: Periodontitis; Intrabony Periodontal Defect; Tooth Migration
• Interventions: Procedure: ParS+Ortho 4W; Procedure: ParS+Ortho 6M

• Registration Number: NCT02761668
• Lead Sponsor: University of Bonn

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-30
• Study First Submitted QC: 2016-05-01
• Study First Posted: 2016-05-04
• Study Start: 2016-10
• Primary Completion: 2020-07-22
• Status Verified: 2023-03
• Study Completion: 2023-03-22
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ParS+Ortho 4W	ParS+Ortho 4W	Orthodontic alignment starts 4 weeks post surgical
ParS+Ortho 6M	ParS+Ortho 6M	Orthodontic alignment starts 6 months post surgical

Primary Outcome Measures

Name	Time	Method
Clinical attachment level (CAL) at test site	12 months	Clinical attachment level (CAL)measurements 12 months after surgery

Secondary Outcome Measures

Name	Time	Method
Probing depth (PD) at test site	24 months	Probing depth (PD) )measurements 12 and 24 months after surgery
Mean probing depth (PD)	24 months	Mean probing depth (PD) )measurements 12 and 24 months after surgery
Bleeding on Probing (BoP) at test site	24 months	Bleeding on Probing (BoP) measurements 12 and 24 months after surgery
Mean bleeding on Probing (BoP)	24 months	Mean Bleeding on Probing (BoP) measurements 12 and 24 months after surgery
Plaque (PI) at test site	24 months	Plaque (PI) measurements 12 and 24 months after surgery
Mean Plaque (PI)	24 months	Plaque (PI) measurements 12 months after surgery
Mean clinical attachment level (CAL)	24 months	Mean clinical attachment level (CAL)12 months after surgery
PROMS	24 months	Patient reported Outcomes

Trial Locations

Locations (2)

Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde; 🇩🇪 Bonn, North Rhine-Westphalia, Germany

Master de Periodoncia Universidad Complutense; 🇪🇸 Madrid, Spain