Evaluation of Two Approaches of Micro-osteoperforations (MOPs) During Orthodontic Canine Retraction

Bimaxillary Protrusion Clinical Trial

Official title:

Evaluation of Two Approaches of Micro-osteoperforations During Orthodontic:A Prospective Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04868721
• Other study ID #: 535/1147
• Status: Completed
• Phase: N/A
• Start date: November 11, 2020
• Est. completion date: June 14, 2022

Study information

• Verified date: June 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this clinical prospective study will be directed to evaluate two approaches of micro-osteoperforations (MOPs) during orthodontic canine retraction.

Description:

The aim of the present clinical study was directed to evaluate the effectiveness of two approaches of micro-osteoperforations (MOPs) during orthodontic canine retraction. This study was conducted on a total sample of 36 canines of 18 patients, 15-22 years old who required therapeutic extraction of maxillary 1st premolars and canine retraction. They were selected randomly from the Outpatient Clinic, Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt. they were randamly dived into two groups:as follows: Group I: include 9 patients , MOPs were performed for one time only on one side before retraction. Group II: include 9 patients , MOPs were performed on repeated basis on one side. Both maxillary canines, in each patient, were randomly assigned to either an experimental side or the control side in a simple split-mouth design. In the experimental side, micro-osteoperforations was performed distal to the maxillary canine at equal distance between maxillary canine and 2nd premolar before starting retraction, while the canines in the contralateral control side were retracted without micro-osteoperforations. Extraction was done at the start of the treatment, and before fitting of the orthodontic appliance. Then upper dental arches were leveled and aligned using conventional sequences of wires. Three flapless micro-osteoperforations was performed by using orthodontic miniscrews distal to the maxillary canines in the experimental side before starting retraction. Each perforation was 1.6 mm in diameter and 3-4 mm depth into the bone. Canines were completely retracted on 0.016 × 0.022 ̋ stainless steel wires by using closed coil spring delivered 150 gm force. Patients were followed up every 28 days for 4 months of canine retraction. Routine orthodontic records were obtained for each patient before treatment. Additionally, a full skull CBCT images were taken before treatment and immediately after canine retraction. The rate of canine retraction was assessed clinically; in addition, cone beam CT (CBCT) scans were used to assess the amount of canine retraction root length changes. Also anchorage loss of first permanent molars were assessed. The treatment results were compared clinically and radiographically (CBCT).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 14, 2022
• Est. primary completion date: February 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 22 Years

Eligibility

Inclusion Criteria:All patients should satisfy the following criteria:-

1. Age range from 15-22 years.

2. Malocclusion cases that require maxillary first premolars extractions followed by symmetrical canine retraction.

3. All permanent teeth present, 3rd molars are excluded.

4. Good oral and general health.

5. No systemic disease/medication that could interfere with OTM.

6. No previous orthodontic treatment.

Exclusion Criteria:

1. Patient diagnosed to have an indication for non-extraction approach.

2. Poor oral hygiene or periodontally compromised patient.

3. Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.

4. Previous orthodontic treatment.

Related Conditions & MeSH terms

• Angle Class II, Division 1
• Bimaxillary Protrusion
• Dental Malocclusions
• Malocclusion
• Malocclusion, Angle Class II

Intervention

Procedure:
• micro-osteoperforations
three flapless micro-osteoperforations was performed distal to the maxillary canine before starting retraction.

Locations

Country	Name	City	State
Egypt	Al azhar university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of canine retraction	clinically, patients were evaluated immediately before canine retraction and every 28days until for months.; It was based on measuring the distance between the contact points on the distal surface of the canines and the contact points on mesial surface of the second premolars.	change from start of canine retraction until 4 months .