N/A
N=28
The Evaluation Of The Efficiency Of Micro-osteoperforation
Crowding of Teeth
Bottom Line
View on ClinicalTrials.gov: NCT03652454 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Rate of Mandibular Teeth Alignment — 4.27; 2.82; 2.08; 2.31 millimeter (mm)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- micro-osteoperforation (Device); conventional fixed appliance treatment (Other)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Izmir Katip Celebi University
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Mandibular Teeth Alignment |
4.27; 2.82; 2.08; 2.31; 1.94; 1.54 | — |
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.
Eligibility Criteria
inclusion Criteria
- Existence of all permanent teeth (except molars 2 and 3)
- Subjects aged 30 and below
- Confusion of less than 8 mm according to model analysis of the upper and lower sieves
- Gingival and periodontal indices of less than 1
- Good oral hygiene
Exclusion Criteria
- Congenitally missing tooth
- Severe skeletal malocclusion
- Systemic disease affecting tooth movement
- Active periodontal disease
- Smoking
- Radiographically detected bone loss
- Gingival pocket depth greater than 4 mm
- Previous surgical periodontal or orthodontic treatment
Data sourced from ClinicalTrials.gov (NCT03652454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.