Micro-osteoperforations and Tooth Movement

Jordan University of Science and Technology

Status: Completed

Conditions: Malocclusion

Treatments: Device: Micro-osteoperforation

Study type: Interventional

Funder types: Other

Identifiers

NCT02473471

JordanUST

Details and patient eligibility

About

The purpose of this study is determine the effect the Microosteoperforation (MOPs) using the miniscrew on the rate tooth movement. Moreover, measurement of the level of the pain and pain's interference, the level of satisfaction and comfort using this protocol. Finally root resorption associate with this technique will be evaluated.

Full description

This study will be randomized, split mouth design controlled trial with a 1:1 allocation ratio. One resident (A.A), calibrated by the main supervisor (S.M), will be reliable for recruiting the subjects, undertaking the orthodontic treatment under the supervision. The eligibility of the cases will be reevaluated by main supervisor (E.M) before the start of treatment.

Split mouth design will be utilized with MOPs that will be randomly assigned to the patients' left or right sides to eliminate the possibility of uneven occlusal forces because of habitual occlusion predominantly on 1 side and also the eliminate the biological variability between subjects. The allocation sequence will be concealed from the researcher (A.A) enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes with the participant's the name and date of birth are written before the intervention. Allocation concealment seeks to prevent selection bias, protects the assignment sequence until allocation.

A Ethical approval will be granted by Jordan University of science and technology research center, and permission will be given at postgraduate dental clinics at Jordan University of science and technology, Irbid, Jordan.

We hypothesized that 50% increased in rate of tooth movement in MOP group would produce a clinically significant difference. The sample size was calculated depend on a type I error frequency of 5%. According to the power analysis and assuming a large effect size difference between groups with 50% of acceleration rate of tooth movement, the power analysis yields a total sample size estimate of 44 samples at a conventional alpha-level (p = 0.05) and desired power (1 - β err prob) of 0.90, yielding 22 samples per group (means 22 patients that represent 22 MOP group and 22 Control group). Assuming an overall attrition rate of 15%, initial recruitment should target a total of 55 samples with 18 patients per group. All calculations were performed with the computer application G-Power (Erdfelder et al., 1996)

Enrollment: 35 patients

Sex: All

Ages: 16 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female
• between 16 to 26 years old
• Class II Division 1 malocclusion or bimaxillary protrusion
• Average Lower facial height and Mandibular plane angle
• No systemic disease
• Healthy periodontal condition
• Non smoker
• Probing depth less than 4 mm in all teeth

Exclusion criteria

• Long-term use of any Medication
• Poor oral hygiene
• Low and high angle cases
• Systemic disease
• Evidence of bone loss
• Active periodontal disease
• Smoker
• Probing depth more than 4 mm in all teeth

Cephalometric analysis of the included subjects was performed at baseline including

1. Sella-Nasion to A Point Angle (SNA): Measure Description: Sella-Nasion-A point (SNA) indicates the horizontal position of the maxilla relative to the cranial base.
2. Sella-Nasion to B Point Angle (SNB): Sella-Nasion-B point (SNB) indicates the horizontal position of the mandible relative to the cranial base.
3. A point to B Point Angle (ANB): A point- Nasion-B point (ANB) indicates the skeletal relationship between the maxilla and mandible.
4. Maxillary mandibular plane angle (MM): The angle formed between the Maxillary Plane and Mandibular Plane. Maxillary Plane is the plane demonstrated by a line through the anterior and posterior nasal spines.A mandibular plane is a plane demonstrated by a line through the gonion and menton.
5. Lower anterior facial height(LAFH)
6. Upper incisor inclination: The angle between the maxillary plane and the axis of the maxillary incisors.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups

MOP side

Experimental group

Description:

Three small holes in cortical bone can be created by Miniscrews.Before application of the MOPs, Patient will be asked to wash their mouth twice by chlorhexidine for 1 minute. Local anesthesia will be given (2% lidocaine with 1:100,000 epinephrine). Microosteoperforation (MOPs) will be performed distal to canine.

Treatment:

Device: Micro-osteoperforation

control side

No Intervention group

Description:

No intervention in the other side of maxilla (control side)