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The Evaluation Of The Efficiency Of Micro-osteoperforation

NCT03652454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-10-03

Study results available
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Summary

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.

Conditions

  • Crowding of Teeth

Interventions

DEVICE

micro-osteoperforation

Propel device (ABD) using for regional acceleratory phenomenon

OTHER

conventional fixed appliance treatment

conventional fixed appliance treatment

Sponsors & Collaborators

  • Izmir Katip Celebi University

    lead OTHER

Principal Investigators

  • Aslı Baysal, PhD · Izmir Katip Celebi University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-03
Primary Completion
2019-06-24
Completion
2019-06-24
FDA Device
Yes

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03652454 on ClinicalTrials.gov