Osseous Evidence Behind Micro-osteoperforation in Accelerating Tooth Movement.

NCT03924726 | Completed

• 1 other identifier: FP018-2017A
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction The study aimed to investigate the effects of micro-osteoperforations (MOPs) on the changes in mandibular bone volume fraction (Bone Volume/Total Volume, BV/TV), in relation to the MOP effects on the rate of orthodontic tooth movement, using CBCT images. The other objective was to evaluate the effects of different frequency intervals (4 weeks, 8 weeks and 12 weeks) of MOPs on mandibular bone volume fraction (BV/TV), in relation to the rate of tooth movement. Methods In 24 participants, orthodontic force of 140-200 grams was applied for mandibular canine retraction. Three micro-osteoperforations (MOP's) were made according to the scheduled intervals of the three different groups (4, 8 and 12 weeks) directly at the mandibular buccal cortical bone of extracted first premolars sites. At the 12th week following MOP application, CBCT scans were performed. CT Analyser software was used to compute trabecular alveolar bone volume fraction (BV/TV).

Conditions

Orthodontics

Outcome Measures

Primary Outcomes (2)

• To investigate the effects of micro-osteoperforations (MOPs) on mandibular bone volume fraction (BV/TV).

  BV/TV ratio was assessed between control and intervention sides to assess the effects of micro-osteoperforations (MOPs) on the changes in mandibular bone volume fraction (Bone Volume/Total Volume, BV/TV ).

  9 months

• To investigate the effects of micro-osteoperforations (MOPs) on the rate of orthodontic tooth movement.

  The effect of MOPs on the rate of canine tooth movement was assessed by comparing the distance of canine retraction between control and micro-osteoperforations sides.

  3 months

Secondary Outcomes (1)

• The other objective was to evaluate the effects of different frequency intervals (4 weeks, 8 weeks and 12 weeks) of MOPs on mandibular bone volume fraction (BV/TV).

  9 months

Study Arms (3)

Control and experimental (4 weeks MOP)

OTHER

This is a split mouth study. At the experimental site in group 1, three Micro-osteoperforation (MOP) were made directly at the buccal cortical bone of extracted first premolars sites, at equidistance from the canine and second premolar under local anaesthesia. This group received four sessions of MOPs at an interval of 4 weeks.

Procedure: Micro-osteoperforation (MOP)

Control and experimental ( 8 weeks MOP)

OTHER

This is a split mouth study. This group received 2 sessions of Micro-osteoperforation (MOP) at an interval of 8 weeks.

Procedure: Micro-osteoperforation (MOP)

Control and experimental (12 weeks MOP)

OTHER

This is a split mouth study. This group received 2 sessions of Micro-osteoperforation (MOP) at an interval of 12 weeks.

Procedure: Micro-osteoperforation (MOP)

Interventions

Micro-osteoperforation (MOP) PROCEDURE

Micro-osteoperforation technique is used to accelerate orthodontic tooth movement.

Control and experimental ( 8 weeks MOP); Control and experimental (12 weeks MOP); Control and experimental (4 weeks MOP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years and above at the start of the treatment.
• Molar relationship either Class I, \< ½ unit Class II or Class III.
• Extraction of all four first premolar teeth as part of orthodontic treatment.
• Maximum anchorage required using mini-implant.
• No systemic disease.
• Good oral hygiene.
• No periodontal disease.

You may not qualify if:

• Significant vertical skeletal discrepancies.
• Systemic diseases requiring long-term antibiotic use, phenytoin, cyclosporin, anti- inflammatory drugs, bisphosphonates, systemic corticosteroids or calcium channel blockers.
• Poor oral hygiene.
• Active periodontal disease.

Sponsors & Collaborators

• University of Malaya: lead
• Ministry of Higher Education, Malaysia: collaborator

Study Sites (1)

Faculty of Dentistry, University of Malaya

Kuala Lumpur, 50603, Malaysia

Location

Study Officials

• Wey M Chek

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 23, 2019
• Study Start: May 10, 2017
• Primary Completion: November 20, 2018
• Study Completion: December 20, 2018
• Last Updated: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)