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Micro-osteoperforations and Tooth Movement

Primary Purpose

Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Micro-osteoperforation
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring Micro-Osteoperforation (MOPs), regional acceleratory phenomenon (RAP), Malocculsion

Eligibility Criteria

16 Years - 26 Years (Child, Adult)All SexesAccepts 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.

Sites / Locations

  • Jordan University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MOP side

control side

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Root Resorption
It will be evaluated by taking periapical radiograph for canines before canine retraction and after 3 months period
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.
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.
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.
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.
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.
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.
Menstrual Cycle
the relationship between the rate of tooth movement and Menstrual cycle

Full Information

First Posted
April 16, 2015
Last Updated
November 24, 2017
Sponsor
Jordan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02473471
Brief Title
Micro-osteoperforations and Tooth Movement
Official Title
Micro-osteoperforations and Tooth Movement: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jordan University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
Micro-Osteoperforation (MOPs), regional acceleratory phenomenon (RAP), Malocculsion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MOP side
Arm Type
Experimental
Arm 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.
Arm Title
control side
Arm Type
No Intervention
Arm Description
No intervention in the other side of maxilla (control side)
Intervention Type
Device
Intervention Name(s)
Micro-osteoperforation
Other Intervention Name(s)
Selective alveolar decortication
Intervention Description
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.
Primary Outcome Measure Information:
Title
3D Digital Model Measurements of Canine Rate of Tooth Movement
Description
The baseline 3D digital model was superimposed to 3D digital models of the 1st month to determine the anterioposterior displacement of canines.
Time Frame
Baseline to 1st month
Title
3D Digital Model Measurements of Canine Rate of Tooth Movement
Description
The baseline 3D digital model was superimposed to 3D digital models of 2nd month to determine the anterioposterior displacement of canines.
Time Frame
Baseline to 2nd month
Title
3D Digital Model Measurements of Canine Rate of Tooth Movement
Description
The baseline 3D digital model was superimposed to 3D digital models of 3rd month to determine the anterioposterior displacement of canines.
Time Frame
Baseline to 3rd month
Title
Intra Oral Measurements of Canine Rate of Tooth Movement
Description
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.
Time Frame
Baseline to 1st month
Title
Intra Oral Measurements of Canine Rate of Tooth Movement
Description
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.
Time Frame
Baseline to 2nd month
Title
Intra Oral Measurements of Canine Rate of Tooth Movement
Description
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.
Time Frame
Baseline to 3 month
Secondary Outcome Measure Information:
Title
Root Resorption
Description
It will be evaluated by taking periapical radiograph for canines before canine retraction and after 3 months period
Time Frame
Baseline to 3rd month
Title
Pain Intensity
Description
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.
Time Frame
within 7 days after the intervention
Title
Pain Interference /Pain During Eating?
Description
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.
Time Frame
within 7 days after the intervention
Title
Pain Interference /Pain Interrupted Sleep
Description
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.
Time Frame
within 7 days after the intervention
Title
Pain Interference /Swelling of the Surgical Side
Description
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.
Time Frame
within 7 days after the intervention
Title
Pain Interference /Discomfort
Description
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.
Time Frame
within 7 days after the intervention
Title
Patient Satisfaction
Description
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.
Time Frame
After 7 days of MOP application
Title
Menstrual Cycle
Description
the relationship between the rate of tooth movement and Menstrual cycle
Time Frame
within 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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. Sella-Nasion to B Point Angle (SNB): Sella-Nasion-B point (SNB) indicates the horizontal position of the mandible relative to the cranial base. A point to B Point Angle (ANB): A point- Nasion-B point (ANB) indicates the skeletal relationship between the maxilla and mandible. 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. Lower anterior facial height(LAFH) Upper incisor inclination: The angle between the maxillary plane and the axis of the maxillary incisors.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal A Alkebsi, MClinDent
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emad Al Maaitah, Ph.D.
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hisham Alshorman, Ph.D.
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elham S. Abu Alhaija, Ph.D
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jordan University of Science and Technology
City
Irbid
ZIP/Postal Code
22110
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
29853235
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.
Results Reference
derived

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Micro-osteoperforations and Tooth Movement

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