Micro-osteoperforations and Tooth Movement

Micro-osteoperforations and Tooth Movement: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Malocclusion
• Intervention / Treatment: Device: Micro-osteoperforation

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)

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Irbid, Jordan, 22110
    • Jordan University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MOP side; 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.	Device: Micro-osteoperforation; Three Micro-osteoperforation (MOPs) will be performed distal to canine by Mini screw. Before the application of the MOPs, Patient will be asked to wash their mouth twice by chorhexidine for 1 minute.; Other Names: Selective alveolar decortication
No Intervention: control side; No intervention in the other side of maxilla (control side)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D Digital Model Measurements of Canine Rate of Tooth Movement	The baseline 3D digital model was superimposed to 3D digital models of the 1st month to determine the anterioposterior displacement of canines.	Baseline to 1st month
3D Digital Model Measurements of Canine Rate of Tooth Movement	The baseline 3D digital model was superimposed to 3D digital models of 2nd month to determine the anterioposterior displacement of canines.	Baseline to 2nd month
3D Digital Model Measurements of Canine Rate of Tooth Movement	The baseline 3D digital model was superimposed to 3D digital models of 3rd month to determine the anterioposterior displacement of canines.	Baseline to 3rd month
Intra Oral Measurements of Canine Rate of Tooth Movement	Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.	Baseline to 1st month
Intra Oral Measurements of Canine Rate of Tooth Movement	Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.	Baseline to 2nd month
Intra Oral Measurements of Canine Rate of Tooth Movement	Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.	Baseline to 3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Root Resorption	It will be evaluated by taking periapical radiograph for canines before canine retraction and after 3 months period	Baseline to 3rd month
Pain Intensity	It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain.	within 7 days after the intervention
Pain Interference /Pain During Eating?	It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain.	within 7 days after the intervention
Pain Interference /Pain Interrupted Sleep	It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain.	within 7 days after the intervention
Pain Interference /Swelling of the Surgical Side	It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no swelling and 10 = worst swelling.	within 7 days after the intervention
Pain Interference /Discomfort	It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no discomfort and 10 = worst discomfort.	within 7 days after the intervention
Patient Satisfaction	It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = unsatisfied and 10 = most satisfaction.	After 7 days of MOP application
Menstrual Cycle	the relationship between the rate of tooth movement and Menstrual cycle	within 3 months

Collaborators and Investigators

• Sponsor: Jordan University of Science and Technology
• Investigators: Principal Investigator: Amal A Alkebsi, MClinDent, Jordan University of Science and Technology; Principal Investigator: Emad Al Maaitah, Ph.D., Jordan University of Science and Technology; Principal Investigator: Hisham Alshorman, Ph.D., Jordan University of Science and Technology; Principal Investigator: Elham S. Abu Alhaija, Ph.D, Jordan University of Science and Technology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: April 16, 2015
• First Submitted That Met QC Criteria: June 12, 2015
• First Posted (Estimate): June 16, 2015

Study Record Updates

• Last Update Posted (Actual): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 24, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Micro-Osteoperforation (MOPs); regional acceleratory phenomenon (RAP); Malocculsion
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: JordanUST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Upon request.
• IPD Sharing Time Frame: As soon as it published and it to be available anytime.
• IPD Sharing Access Criteria: Official departments of recognized universities
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No