The Evaluation Of The Efficiency Of Micro-osteoperforation

NCT ID: NCT03652454

Last Updated: 2022-10-03

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-03

Study Completion Date

2019-06-24

Brief Summary

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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.

Detailed Description

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Twenty eight patients who have crowding in mandibular arch will be included in the study.

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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Crowding of Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
single outcome assessor

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.

Group Type EXPERIMENTAL

micro-osteoperforation

Intervention Type DEVICE

Propel device (ABD) using for regional acceleratory phenomenon

conventional fixed appliance treatment

Intervention Type OTHER

conventional fixed appliance treatment

conventional treatment

conventional fixed appliance treatment

Group Type OTHER

conventional fixed appliance treatment

Intervention Type OTHER

conventional fixed appliance treatment

Interventions

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micro-osteoperforation

Propel device (ABD) using for regional acceleratory phenomenon

Intervention Type DEVICE

conventional fixed appliance treatment

conventional fixed appliance treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Existence of all permanent teeth (except molars 2 and 3)
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

1. Congenitally missing tooth
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
Minimum Eligible Age

12 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Izmir Katip Celebi University

OTHER

Sponsor Role lead

Responsible Party

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Asli Baysal

Assoc. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

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)

Site Status

Countries

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Turkey (Türkiye)

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.

Reference Type DERIVED
PMID: 37167078 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2016TDRSABE0026

Identifier Type: -

Identifier Source: org_study_id

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