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OrthodonticsNCT03924726

Osseous Evidence Behind Micro-osteoperforation in Accelerating Tooth Movement.

A study testing Micro-osteoperforation (MOP) in people with Orthodontics, run by University of Malaya at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Orthodontics
What is being tested?
Micro-osteoperforation (MOP)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteMalaysia
Study dates
10 May 2017to 20 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Malaysia1 site
  • Faculty of Dentistry, University of Malaya

    Kuala Lumpur, 50603

Other trials in Malaysia

About this study

Official title: Osseous Evidence Behind Micro-osteoperforation Technique in Accelerating Orthodontic Tooth Movement Towards Reducing Treatment Duration.

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.

Read more

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).

Read the detailed description

This study is a single centred, single-blinded, prospective randomised split-mouth clinical trial conducted at University of Malaya. The ethical approval for the present study was obtained from the institutional Medical Ethics Committee (DF CD1608/0059P). Written informed consents were obtained from all participants prior to the study. Cone beam computed tomography (CBCT) (Kodak 9000) images was used to assess the trabecular alveolar bone volume fraction (BV/TV) at micro-osteoperforations (MOPs) sides. The rate of orthodontic tooth movement was assessed by comparing the available space between control and MOP sites in three different interval groups. Twenty-four participants were selected according to the study selection criteria. Inclusion criteria was (1) aged 18 years and above at the start of the treatment, (2) molar relationship either Class I, < ½ unit Class II or Class III, (3) extraction of all four first premolar teeth as part of orthodontic treatment, (4) maximum anchorage required using mini-implant, (5) no systemic disease, (6) good oral hygiene and (7) no periodontal disease. Participants were excluded if they had 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 for more than visits or active periodontal disease.

Sample size calculation

G*Power software (version 3.1.9.2) was used to calculate the total sample size of 24 using t tests to achieve a power of 80% and a level of significance of 5% (two sided), for detecting an effect size of 0.60 between pairs. However, 30 samples were selected to compensate for any dropouts during the study.

Demographic characteristic

Twenty-four participants were stratified in 3 study groups (4, 8 and 12 weeks) based on frequency intervention intervals. Ethnically, there were 11 Malay samples (45.8%), 10 Chinese samples (41.7%) and 3 Indian samples (12.5%). Gender and ethnic distribution was not equal within the study groups due to the limited sample size, as a result gender variance was not assessed in the present study.

Micro-osteoperforations and canine retraction

The lower dentition was bonded with preadjusted edgewise brackets (3M Unitek, 0.022" x 0.028" slot in MBT prescription), and the first and second molars banded (3M Unitek, 0.022" x 0.028" slot in MBT prescription). Mini-implants were inserted in the keratinised gingiva between the second premolars and first molars bilaterally for both indirect and direct anchorage purposes. Canine retraction was done one month after insertion of a stainless-steel working archwire (0.018 x 0.025-inch SS) (GAC PAK Stainless Steel ACCUFORM®), using power chain (3M Unitek Alastik TM elastomeric chain), with a force of 140-200 grams (measured directly using a Correx Force Tension gauge, Haag-Streit Diagnostics, Switzerland), engaged from the canines to the mini-implants. The distance of canine movement was recorded every four weeks with digital callipers accurate to 0.01 mm, for a period of 12 weeks.

Micro-osteoperforations were performed according to the scheduled intervals of the three different groups. At the experimental site, three micro-osteoperforations were made directly at the buccal cortical bone of extracted first premolars sites, at equidistance from the canine and second premolar under local anaesthesia. The MOPs were 2 mm apart in vertical direction and 3 mm depth. The first MOP were placed starting at the horizontal level of the cervical margin of the canine tooth and extending apically. Orlus Extra Thread mini-implant (1.6 mm width, 6 mm length) with a rubber stopper at a measured length (depth of micro-osteoperforation at 3 mm and soft tissue thickness was taken into consideration) was used to perform MOPs. Group1 received four sessions of MOPs, group 2 and group 3 received two sessions of MOPs. At the 12th week following MOP application, CBCT scans of the left and right mandibular quadrants (both control and intervention side) were acquired.

Radiographic evaluation of trabecular bone volume fraction

CBCT (Kodak 9000, Carestream) exposure parameters were 70KV, 8mA, 10.8s and voxel size of 76 µm. The DICOM® (Digital Imaging and Communications in Medicine) format of CBCT images were converted into BMP (Bitmap image) files using ImageJ software (Version 1.50i) before analysing the trabecular bone volume fraction (BV/TV) in CT Analyser software (version 1.11.0.0 copyright Sky Scan).

Blinding

Both the observers (orthodontic postgraduate students) were blinded to the frequency of MOP whilst analysing the bone volume fraction (BV/TV) using CT analyser software as CBCT files were labelled by random numbers.

Image Analysis

In CT Analyser, a region of interest (ROI) was identified between canine and second premolar teeth. The top slice of the ROI started from a slice apical to the cemento-enamel junction of canine. The bottom slice of the ROI was determined by subtracting 14.8mm from the Z-position of the upper slice on the axial view of CBCT image. A polygonal tool was used to mark the ROI at the top and bottom layers. Then a dynamic interpolation was applied to create an adaptive ROI. Then, the ROI was binarized using the threshold values obtained from the control side of each patient (Figure 4). The range of threshold values was determined by checking the threshold value of the cortical bone in the binary histogram. After binarization, the percentage of bone volume (BV/TV) was calculated.

Conditions
Orthodontics
Being tested
Micro-osteoperforation (MOP)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Micro-osteoperforation (MOP)Procedure or surgery

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

Study groups in NCT03924726
Study groupRoleWhat they receive
Control and experimental (4 weeks MOP)OtherThis 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.
Receives: Procedure: Micro-osteoperforation (MOP)
Control and experimental ( 8 weeks MOP)OtherThis is a split mouth study. This group received 2 sessions of Micro-osteoperforation (MOP) at an interval of 8 weeks.
Receives: Procedure: Micro-osteoperforation (MOP)
Control and experimental (12 weeks MOP)OtherThis is a split mouth study. This group received 2 sessions of Micro-osteoperforation (MOP) at an interval of 12 weeks.
Receives: Procedure: Micro-osteoperforation (MOP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 ).

    Measured: 9 months

  2. 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.

    Measured: 3 months

Secondary outcomes (1)
  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).

    Bone volume fraction (BV/TV) was assessed by comparing the available space between control and MOP sites in three different interval groups.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2019
  2. Study start10 May 2017
  3. Primary completion20 Nov 2018
  4. Study completion20 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03924726
Sponsor's protocol ID
FP018-2017A
Status last verified
Apr 2019
First submitted
12 Apr 2019
Last updated
23 Apr 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Questions about this trial

What is this clinical trial studying?

A study testing Micro-osteoperforation (MOP) in people with Orthodontics, run by University of Malaya at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To investigate the effects of micro-osteoperforations (MOPs) on mandibular bone volume fraction (BV/TV). (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.

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