CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
ParS+Ortho 4W +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02761668
NCT02761668N/ACompleted

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.

University of Bonn·interventional·Posted May 4, 2016·Updated Mar 30, 2023

In Brief

A clinical study evaluating ParS+Ortho 4W and ParS+Ortho 6M for Periodontitis and 2 related conditions. Completed, enrolled 44 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Spain

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 4, 2016
Enrollment StartOct 1, 2016
Primary CompletionJul 22, 2020
Study CompletionMar 22, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.2 years ago

Interventions

ParS+Ortho 4Wprocedure

Orthodontics 4 weeks post surgical

ParS+Ortho 6Mprocedure

Orthodontics 6 months post surgical