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.
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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Micro-osteoperforation (MOP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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.
- First posted23 Apr 2019
- Study start10 May 2017
- Primary completion20 Nov 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthodonticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Higher Education, Malaysia
- Responsible party
- Principal investigator, Wey Mang Chek, University of Malaya
- Investigators
- Wey M Chek, Principal investigator, University of Malaya
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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osseous Evidence Behind Micro-osteoperforation Technique in Accelerating Orthodontic Tooth Movement Towards Reducing Treatment Duration.
- ClinicalTrials.gov ID
- NCT03924726
- Acronym / sponsor ID
- FP018-2017A
- Conditions
- Orthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Ministry of Higher Education, Malaysia
- Study start
- 10 May 2017 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control and experimental (4 weeks MOP) | Other | Procedure: Micro-osteoperforation (MOP)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. |
| Control and experimental ( 8 weeks MOP) | Other | Procedure: Micro-osteoperforation (MOP)This is a split mouth study. This group received 2 sessions of Micro-osteoperforation (MOP) at an interval of 8 weeks. |
| Control and experimental (12 weeks MOP) | Other | Procedure: Micro-osteoperforation (MOP)This is a split mouth study. This group received 2 sessions of Micro-osteoperforation (MOP) at an interval of 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro-osteoperforation (MOP)Micro-osteoperforation technique is used to accelerate orthodontic tooth movement. | Procedure or surgery | Control and experimental ( 8 weeks MOP), Control and experimental (12 weeks MOP), Control and experimental (4 weeks MOP) |
Primary outcome
To investigate the effects of micro-osteoperforations (MOPs) on mandibular bone volume fraction (BV/TV).
Time frame: 9 months
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 ).
To investigate the effects of micro-osteoperforations (MOPs) on the rate of orthodontic tooth movement.
Time frame: 3 months
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.
1 secondary outcome
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).
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wey M Chek principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
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.