The Effect of Combination of Micro-osteoperforation and a Vibration Device on Orthodontic Tooth Movement : A Prospective Randomized Clinical trial

Determining the effect of the combination of micro-osteoperforation and a vibration device on the rate of orthodontic tooth movement.

Controlled clinical trial with parallel group, single- blinded, randomized, on 20 patients. The "Balanced Block Randomization" method is used for randomization.

Three months after extraction of the first maxillary premolars, canine retraction begins in both groups in the Orthodontic Department, School of Dentistry, Tehran University of Medical Sciences. Micro-osteoperforations are performed on the buccal and palatal surfaces, right and left sides of the maxilla, just before the canine retraction. Patients in the intervention group use a vibration device from the initial stage of retraction, 5 minutes a day. Alginate impressions are taken at the beginning of the study, immediately before retraction, and 28 days after the onset of canine retraction.The amount of orthodontic movement of canine teeth is measured on patients' dental casts using a digital caliper. Blinding of the patients and clinical researcher is not possible; but blinding of the persons responsible for data collection and outcome evaluation is possible.

Inclusion criteria : age range (18 to 45 years) , maxillary canine teeth fully erupted, need to extract both first maxillary premolars, existence of 3 mm space after initial alignment, good oral hygiene. Exclusion criteria : systemic diseases affecting bone metabolism, take any medication, periodontal disease, smoking, pregnancy.

Intervention group: receives micro-osteoperforations on both sides (right and left) of the maxilla along with using a C-shaped vibration device. Control group: receives micro-osteoperforations on both sides of the maxilla without using a vibration device.

Rate of orthodontic tooth movement

In this study, the "Balanced Block Randomization" method will be used. In this method, 4 blocks (envelopes) of equal size are prepared. In each block, sheets are randomly assigned to the control group (B) and/or the intervention group (A) using the RAND option of Excel software. The randomization process will be performed by the Methodology and Research Consultant of the study and the clinical researcher will not be aware of the type of intervention until the study begins (allocation concealment). The person performing the randomization process, places the letters A as the intervention group and the letters B as the control group on sheets inside the sealed envelopes. These envelopes will be numbered from 1 to 4 . At the beginning of the study and the arrival of patients (participants), envelope 1 to envelope 4 will be used, respectively, and when working on the patient, the envelope will be opened and the type of intervention will be determined. Randomization unit: Individual Randomization tool: Excel software

Patients (participants) blinding is not possible because one of the study interventions is vibration that is perceived by the patients. Blinding the clinical researcher is also not possible. Because the responsible persons for data collection and outcome evaluation are different from the practitioner (clinical researcher) and while collecting data and evaluating the outcome, they do not know which control and / or intervention group the patient belongs to, blinding of the persons responsible for data collection and outcome evaluation is possible.

Individual unidentifiable data of the participants including age, sex, type of malocclusion and data obtained from the study such as the effect of intervention on the rate of orthodontic tooth movement.

Access period starts 6 months after the results are published.

Faculty members of the universities of medical sciences

Using data for systematic review

Applicants can refer to the corresponding author " Dr. Sarvin Sarmadi" to get the study data. Postal address: Department of Orthodontics, School of Dentistry, Tehran University of Medical Sciences, North Karegar St., Tehran, Iran. Postal code: 1439955991 Email : sarmadis@sina.tums.ac.ir Phone : 0098 21 88015801

After receiving the request of an applicant and consulting the first and the corresponding authors of the article, the documents will be delivered to the applicant within 1 working month.