Micro-osteoperforations and Tooth Movement

Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473471
• Other study ID #: JordanUST
• Status: Completed
• Phase: N/A
• First received: April 16, 2015
• Last updated: November 24, 2017
• Start date: April 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2017
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion

Intervention

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.

Locations

Country	Name	City	State
Jordan	Jordan University of Science and Technology	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Root Resorption	It will be evaluated by taking periapical radiograph for canines before canine retraction and after 3 months period	Baseline to 3rd month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Menstrual Cycle	the relationship between the rate of tooth movement and Menstrual cycle	within 3 months