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NCT03652454

The Evaluation Of The Efficiency Of Micro-osteoperforation

Completed NA Results posted Last updated 3 October 2022
What this trial tests

NA trial testing micro-osteoperforation in Crowding of Teeth in 28 participants. Completed in 24 June 2019.

Timeline
3 October 2017
Primary endpoint
24 June 2019
24 June 2019

Quick facts

Lead sponsorIzmir Katip Celebi University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment28
Start date3 October 2017
Primary completion24 June 2019
Estimated completion24 June 2019
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Izmir Katip Celebi University

Who can join

Adults 12 to 30, any sex, with Crowding of Teeth. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rate of Mandibular Teeth Alignment Primary · From the initiation of the treatment to the completion of alignment stage (approximately 6 months)

tooth movement rate (mm/month) was calculated. From the initiation of the treatment to the completion of alignment stage (approximately 6 months). All tooth movement rate measurements were performed in each month.

first month
GroupValue95% CI
Micro-osteoperforation4.27± 1.75
Conventional Treatment2.82± 0.87
second months
GroupValue95% CI
Micro-osteoperforation2.08± 0.91
Conventional Treatment2.31± 1.29
third months
GroupValue95% CI
Micro-osteoperforation1.94± 0.99
Conventional Treatment1.54± 0.65
fourth months
GroupValue95% CI
Micro-osteoperforation0.84± 0.95
Conventional Treatment0.89± 0.49
fifth months
GroupValue95% CI
Micro-osteoperforation0.34± 0.57
Conventional Treatment0.93± 0.7

Sponsor's own description

Prolonged orthodontic treatment increases the risc of caries, periodontal problems and root resorption. Many different techniques were developed to shorten the treatment time. The aim of this study was to evaluate the effectiveness of micro-osteoperforations (MOP) performed in the alignment stage. Twenty eight patients with mandibular arch discrepancy will be included in this research. After the patients are informed about the study they will be requested to sign the consent form.. At the beginning of the treatment routine orthodontic records (photographs, dental models and radiographs) will be taken and the gingival pocket measurements will be made. The twenty eight patients will be randomly divided in two groups. In the first group, 3 or 4 micro-osteoperforations will be made in the parts of the gingiva nearby the discrepancy by perforating the keratinized or non-keratinized mucosa and reaching the alveolar bone under local anesthesia. In the further appointments the traditional aligning procedures will be used and controls will be made every 7-9 days. In the other group 20 patients will be treated in the traditional way and controls will be made each month. Every patient will be requested to answer questions related to treatment comfort and other problems like pain within the first week after each activations. The records will be repeated after the leveling phase. Tooth movement rate will be calculated according to the measurements made on dental casts. Measurements related to cephalometrics and gingival thickness will be evaluated. The results of two groups will be compared in terms of tooth movement rate, gingival thickness, pain and patient comfort.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Orthodontic treatment for crowded teeth in children.
    Turner S, Harrison JE, Sharif FN, Owens D, et al · · 2021 · cited 17× · PMID 34970995 · DOI 10.1002/14651858.cd003453.pub2
  2. The effect of micro-osteoperforation on the rate of tooth movement during the alignment stage in patients with mandibular crowding: a randomised controlled trial.
    Faik Sahin M, Baysal A. · · 2023 · cited 1× · PMID 37167078 · DOI 10.1093/ejo/cjad017

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03652454.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing