Clinical trial NCT02473471: Micro-osteoperforations and Tooth Movement
Official title: Micro-osteoperforations and Tooth Movement: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Keywords: Micro-Osteoperforation (MOPs)
regional acceleratory phenomenon (RAP)
Malocculsion
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 35
Sex: ALL
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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)

Eligibility criteria: 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.

Primary outcomes:
measure: 3D Digital Model Measurements of Canine Rate of Tooth Movement
timeFrame: Baseline to 1st month
measure: 3D Digital Model Measurements of Canine Rate of Tooth Movement
timeFrame: Baseline to 2nd month
measure: 3D Digital Model Measurements of Canine Rate of Tooth Movement
timeFrame: Baseline to 3rd month
measure: Intra Oral Measurements of Canine Rate of Tooth Movement
timeFrame: Baseline to 1st month
measure: Intra Oral Measurements of Canine Rate of Tooth Movement
timeFrame: Baseline to 2nd month
measure: Intra Oral Measurements of Canine Rate of Tooth Movement
timeFrame: Baseline to 3 month
Secondary outcomes:
measure: Root Resorption
timeFrame: Baseline to 3rd month
measure: Pain Intensity
timeFrame: within 7 days after the intervention
measure: Pain Interference /Pain During Eating?
timeFrame: within 7 days after the intervention
measure: Pain Interference /Pain Interrupted Sleep
timeFrame: within 7 days after the intervention
measure: Pain Interference /Swelling of the Surgical Side
timeFrame: within 7 days after the intervention
measure: Pain Interference /Discomfort
timeFrame: within 7 days after the intervention
measure: Patient Satisfaction
timeFrame: After 7 days of MOP application
measure: Menstrual Cycle
timeFrame: within 3 months
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Amal A Alkebsi, MClinDent
role: PRINCIPAL_INVESTIGATOR
affiliation: Jordan University of Science and Technology
name: Emad Al Maaitah, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jordan University of Science and Technology
name: Hisham Alshorman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jordan University of Science and Technology
name: Elham S. Abu Alhaija, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alkebsi A, Al-Maaitah E, Al-Shorman H, Abu Alhaija E. Three-dimensional assessment of the effect of micro-osteoperforations on the rate of tooth movement during canine retraction in adults with Class II malocclusion: A randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):771-785. doi: 10.1016/j.ajodo.2017.11.026.