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The Evaluation Of The Efficiency Of Micro-osteoperforation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03652454
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Information provided by (Responsible Party):
Asli Baysal, Izmir Katip Celebi University

Brief Summary:

Orthodontic treatment is a long treatment that requires the cooperation of the patient. If the duration of treatment becomes greater than expected the patient 's participation is reduced. Beside that, the prolonged orthodontic treatment increases the risc of caries, periodontal problems and resorption. There were developed many different techniques that can shorten the treatment time until nowadays. Especially periodontal surgical assisted orthodontic treatment , has gained special interest among orthodontists due to its beneficial results. For this reason, the micro-osteoperforation method's effect will be evaluated in one of the most important phases of the treatment such as the leveling phase aiming the shortening of treatment time.

Forty patients with maxillary and mandibular arch discrepancy and have not under gone orthodontic treatment before will be included in this research. After the patients will be informed about the study they will be requested to sign the consent form. As the first phase of the study the appointment for orthodontic records will be given to the patient. 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. In the beginning and at the and of the treatment long cone periapical radiographs will be taken in each patient in order to estimate the anterior lower root dimensions.

The forty 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 during the first week after each activation. In the pain scoring 'no pain- not resistable pain' information will be given a score from 0-to 10 as established by the visual analog scale method.

The records will be repeated after the leveling phase. The measurements made on dental casts will give results about tooth movement rate. Linear and angular measurements will be made in radiographs and gingival thickness will be evaluated. The results taken from the two groups will be compared in base of tooth movement rate, gingival thickness, pain and patient comfort.

Condition or disease Intervention/treatment Phase
Crowding of Teeth Device: micro-osteoperforation Other: conventional fixed appliance treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficiency Of Micro-osteoperforation During Alignment Stage
Actual Study Start Date : October 3, 2017
Estimated Primary Completion Date : October 3, 2018
Estimated Study Completion Date : December 3, 2018

Arm Intervention/treatment
Experimental: micro-osteoperforation
Propel device (ABD)
Device: micro-osteoperforation
Propel device (ABD) using for regional acceleratory phenomenon

conventional treatment
conventional fixed appliance treatment
Other: conventional fixed appliance treatment
conventional fixed appliance treatment

Primary Outcome Measures :
  1. rate of mandibular teeth alignment [ Time Frame: 12 months of mandibular teeth alignment ]
    tooth movement per month (mm/month)

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  • Mouth hygiene be good

Exclusion Criteria:

  • Congenital incomplete ablated tooth
  • Severe skeletal malocclusion
  • Systemic disease affecting tooth movement
  • No active periodontal disease
  • Smoking • Radiographic bone loss
  • Gingival pocket depth greater than 4 mm
  • Surgical periodontal or orthodontic treatment in the past have seen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03652454

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Izmır Katıp Celebı Univercity Recruiting
İzmir, Turkey, 35360
Contact: aslı baysal, prof    +905332407968      
Sponsors and Collaborators
Izmir Katip Celebi University

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Responsible Party: Asli Baysal, Assoc. Prof. Dr., Izmir Katip Celebi University Identifier: NCT03652454    
Other Study ID Numbers: 2016TDRSABE0026
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Asli Baysal, Izmir Katip Celebi University:
regional acceleratory phenomenon
orthodontic alignment