The Evaluation Of The Efficiency Of Micro-osteoperforation

September 22, 2022 updated by: Asli Baysal, Izmir Katip Celebi University

Efficiency Of Micro-osteoperforation During Alignment Stage

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmirli, Turkey
        • Izmir Katip Celebi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: micro-osteoperforation
Propel device (ABD) using for regional acceleratory phenomenon
Other: conventional fixed appliance treatment
conventional fixed appliance treatment
Other: conventional treatment
conventional fixed appliance treatment
Other: conventional fixed appliance treatment
conventional fixed appliance treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Mandibular Teeth Alignment
Time Frame: 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.
From the initiation of the treatment to the completion of alignment stage (approximately 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Investigators

  • Study Director: Aslı Baysal, PhD, Izmir Katip Celebi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2017

Primary Completion (Actual)

June 24, 2019

Study Completion (Actual)

June 24, 2019

Study Registration Dates

First Submitted

October 18, 2017

First Submitted That Met QC Criteria

August 28, 2018

First Posted (Actual)

August 29, 2018

Study Record Updates

Last Update Posted (Actual)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 22, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016TDRSABE0026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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