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

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

Interventions

PROCEDURE

ParS+Ortho 4W

Orthodontics 4 weeks post surgical

PROCEDURE

ParS+Ortho 6M

Orthodontics 6 months post surgical

Sponsors & Collaborators

• Universidad Complutense de Madrid

  collaborator OTHER

• University of Bonn

  lead OTHER

Principal Investigators

• Søren Jepsen, Phd · Director

• Karin Jepsen, Dr · OA

• Andreas Jaeger, Phd · Director

• Conchita Martin, PhD · Faculty of Odontology, UCM

• Mariano Sanz, PhD · Faculty of Odontology, UCM

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-10-31

Primary Completion

2020-07-22

Completion

2023-03-22

Countries

• Germany
• Spain

Study Locations