Micro-osteoperforations and Tooth Movement

• ClinicalTrials.gov Identifier: NCT02473471
• Recruitment Status: Completed
• First Posted: June 16, 2015
• Results First Posted: November 22, 2017
• Last Update Posted: November 28, 2017
• Sponsor: Jordan University of Science and Technology
• Information provided by (Responsible Party): Amal Alkebsi, Jordan University of Science and Technology

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Malocclusion	Device: Micro-osteoperforation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Micro-osteoperforations and Tooth Movement: A Randomized Controlled Clinical Trial
• Study Start Date: April 2015
• Actual Primary Completion Date: November 2016
• Actual Study Completion Date: November 2016

Arms and Interventions

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 Name: Selective alveolar decortication
No Intervention: control side; No intervention in the other side of maxilla (control side)

Outcome Measures

Primary Outcome Measures :

1. 3D Digital Model Measurements of Canine Rate of Tooth Movement [ Time Frame: Baseline to 1st month ]
   The baseline 3D digital model was superimposed to 3D digital models of the 1st month to determine the anterioposterior displacement of canines.
2. 3D Digital Model Measurements of Canine Rate of Tooth Movement [ Time Frame: Baseline to 2nd month ]
   The baseline 3D digital model was superimposed to 3D digital models of 2nd month to determine the anterioposterior displacement of canines.
3. 3D Digital Model Measurements of Canine Rate of Tooth Movement [ Time Frame: Baseline to 3rd month ]
   The baseline 3D digital model was superimposed to 3D digital models of 3rd month to determine the anterioposterior displacement of canines.
4. Intra Oral Measurements of Canine Rate of Tooth Movement [ Time Frame: Baseline to 1st month ]
   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.
5. Intra Oral Measurements of Canine Rate of Tooth Movement [ Time Frame: Baseline to 2nd month ]
   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.
6. Intra Oral Measurements of Canine Rate of Tooth Movement [ Time Frame: Baseline to 3 month ]
   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.

Secondary Outcome Measures :

1. Root Resorption [ Time Frame: Baseline to 3rd month ]
   It will be evaluated by taking periapical radiograph for canines before canine retraction and after 3 months period
2. Pain Intensity [ Time Frame: within 7 days after the intervention ]
   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.
3. Pain Interference /Pain During Eating? [ Time Frame: within 7 days after the intervention ]
   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.
4. Pain Interference /Pain Interrupted Sleep [ Time Frame: within 7 days after the intervention ]
   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.
5. Pain Interference /Swelling of the Surgical Side [ Time Frame: within 7 days after the intervention ]
   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.
6. Pain Interference /Discomfort [ Time Frame: within 7 days after the intervention ]
   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.
7. Patient Satisfaction [ Time Frame: After 7 days of MOP application ]
   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.
8. Menstrual Cycle [ Time Frame: within 3 months ]
   the relationship between the rate of tooth movement and Menstrual cycle

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 26 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Jordan

Jordan University of Science and Technology

Irbid, Jordan, 22110

Sponsors and Collaborators

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

  Study Documents (Full-Text)

Documents provided by Amal Alkebsi, Jordan University of Science and Technology:

Study Protocol and Statistical Analysis Plan  [PDF] February 21, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Amal Alkebsi, MClindent in Orthodontics, Department of Preventive Dentistry, Faculty of Dentistry, Jordan University of Science and Technology
• ClinicalTrials.gov Identifier: NCT02473471
• Other Study ID Numbers: JordanUST
• First Posted: June 16, 2015
• Results First Posted: November 22, 2017
• Last Update Posted: November 28, 2017
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

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

Keywords provided by Amal Alkebsi, Jordan University of Science and Technology:

Micro-Osteoperforation (MOPs); regional acceleratory phenomenon (RAP); Malocculsion

Additional relevant MeSH terms:

Malocclusion; Tooth Diseases; Stomatognathic Diseases