The Evaluation Of The Efficiency Of Micro-osteoperforation
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|ClinicalTrials.gov Identifier: NCT03652454|
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Propel device (ABD)
Propel device (ABD) using for regional acceleratory phenomenon
conventional fixed appliance treatment
Other: conventional fixed appliance treatment
conventional fixed appliance treatment
- rate of mandibular teeth alignment [ Time Frame: 12 months of mandibular teeth alignment ]tooth movement per month (mm/month)
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 ClinicalTrials.gov identifier (NCT number): NCT03652454
|Contact: ASLI BAYSAL, PROF||+905332407968||BAYSALASLI@HOTMAIL.COM|
|Contact: MUCAHID FAIK SAHIN, ASSISTANT||+905546883915||M.FAIKSAHIN@HOTMAIL.COM|
|Izmır Katıp Celebı Univercity||Recruiting|
|İzmir, Turkey, 35360|
|Contact: aslı baysal, prof +905332407968|