The Evaluation Of The Efficiency Of Micro-osteoperforation
NCT ID: NCT03652454
Last Updated: 2022-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2017-10-03
2019-06-24
Brief Summary
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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.
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Detailed Description
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At the beginning of the study, routine orthodontic records and gingival measurements will be taken.All the records will be repeated after alignment stage.
Clinical periodontal parameters including plaque index, gingival index, pocket depth and bleeding were measured with Williams periodontal scaler (Hu Friedy®, Chicago, IL, USA).
Gingival thickness will be recorded with a ultrasonic device (Pirop® Ultrasonic Biometer A- Scan, Echo-Son, Krancowa, Poland) Irregularity index will be calculated for each patient using dental casts. After bracket placement; twenty eight patients will be randomly allocated to treatment and control groups (fourteen patients in each group) While micro-osteoperforations will be applied to treatment group, the control group will receive no additional treatment.
Each patient will be asked to fulfill a questionnaire to evaluate patient satisfaction and ease of operation.
The data was analyzed statistically and the level of statistical significance was determined as p ≤ .05.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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micro-osteoperforation
Propel device (ABD) Micro-osteoperforations were performed in the keratinized tissue. Micro-osteoperforations were 1.5 mm in diameter and 3-7 mm in depth.
micro-osteoperforation
Propel device (ABD) using for regional acceleratory phenomenon
conventional fixed appliance treatment
conventional fixed appliance treatment
conventional treatment
conventional fixed appliance treatment
conventional fixed appliance treatment
conventional fixed appliance treatment
Interventions
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micro-osteoperforation
Propel device (ABD) using for regional acceleratory phenomenon
conventional fixed appliance treatment
conventional fixed appliance treatment
Eligibility Criteria
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Inclusion Criteria
2. Subjects aged 30 and below
3. Confusion of less than 8 mm according to model analysis of the upper and lower sieves
4. Gingival and periodontal indices of less than 1
5. Good oral hygiene
Exclusion Criteria
2. Severe skeletal malocclusion
3. Systemic disease affecting tooth movement
4. Active periodontal disease
5. Smoking
6. Radiographically detected bone loss
7. Gingival pocket depth greater than 4 mm
8. Previous surgical periodontal or orthodontic treatment
12 Years
30 Years
ALL
Yes
Sponsors
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Izmir Katip Celebi University
OTHER
Responsible Party
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Asli Baysal
Assoc. Prof. Dr.
Principal Investigators
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Aslı Baysal, PhD
Role: STUDY_DIRECTOR
Izmir Katip Celebi University
Locations
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Izmir Katip Celebi University
İzmirli, , Turkey (Türkiye)
Countries
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References
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Faik Sahin M, Baysal A. The effect of micro-osteoperforation on the rate of tooth movement during the alignment stage in patients with mandibular crowding: a randomised controlled trial. Eur J Orthod. 2023 Sep 18;45(5):505-516. doi: 10.1093/ejo/cjad017.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016TDRSABE0026
Identifier Type: -
Identifier Source: org_study_id
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