MalocclusionMOPNCT03888560

Duration Of Lower Labial Segment Alignment With Repeated Micro-Osteoperforations:

A study testing Micro-osteoperforations in people with Malocclusion, 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.

Trial summary

The main purpose is to compare overall alignment time (OAT) in days in alleviating mandibular incisors crowding between control group and MOPs group.Furthermore, to investigate the presence of volumetric root resorption from CBCT, gingival recession and formation of black triangle post lower labial segment alignment… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Malocclusion
What is being tested?: Micro-osteoperforations
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteMalaysia
Study dates: 19 Nov 2018to 14 Apr 2021
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 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Gender : Male and Female
Age range : ≥ 18years to 45 years old
Crowding of 3mm - 7mm on lower labial segment (lower right canine to lower left canine) which does not require extractions in the lower arch
Class II div I Incisor relationship with extraction of both upper 1st premolars
Maximum anchorage control with temporary anchorage device ( TAD) , with Molar Class II (¼ to full unit) malocclusion
Average vertical facial proportions

Show all 9Show fewer

No systemic disease
Acceptable good oral hygiene
No periodontal disease

Who cannot join

Smokers
Distally angulated canines
History of trauma (crown fracture or avulsion and re-implantation) , endodontic treatment
Missing permanent mandibular anterior teeth ( Hypodontia) / Retained deciduous teeth in mandibular anterior area
Habits eg: fingernails biting , toothpick user , using hard toothbrush
Vertical skeletal discrepancies eg high angle and low angle

Show all 9Show fewer

Systemic disease especially on long term use of antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroid and calcium channel blockers
Poor oral hygiene for more than 3 visits
Current periodontal disease

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

Faculty of Dentistry , University of Malaya
Kajang, Kuala Lumpur, 50603

Other trials in Malaysia

About this study

Official title: Duration Of Lower Labial Segment Alignment With Repeated Micro-Osteoperforations: Randomised Controlled Clinical Trial

Read the detailed description

Prolonged treatment time in orthodontics is an undesirable side effect for both the patient and clinician. Usually, an average course of comprehensive orthodontic treatment with fixed appliances requires less than 2 years to complete (19.9 months). This prolonged treatment time may cause adverse effects such as root resorption, gingival recession, caries \& enamel demineralization. Micro-osteoperforations is safe, minimally invasive technique which perforations are performed through the gum tissues, penetrating the bone without the need to raise a ﬂap.Control group will not received any MOP and will receive standard orthodontic treatment.

Conditions: Malocclusion
Being tested: Micro-osteoperforations
Keywords: micro-osteperforation, orthodontic tooth movement, treatment duration
Medical subject headings: Malocclusion

What participants receive

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

Micro-osteoperforationsDevice
MOPs will be performed using SIA Excalibur Mini-Implant with dimension 1.6 mm in width and length of 6 mm, screw 3 mm depth into buccal bone of intervention sites

Study groups in NCT03888560
Study group	Role	What they receive
Micro-osteoperforations	Experimental	Lower arch, 2 MOPs vertically at interdental area bilaterally mesial to lower 6's ; mesial to lower 1st premolar; mesial to lower 2's and between the lower 1's..The start date of lower labial segment alignment (T1) was recorded after insertion of the lower 0.014'' NiTi archwire. Participants were reviewed every 6 weeks and repeated MOPs were performed for the experimental group until the completion of lower labial segment alignment (LLS), which is when the Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine. Receives: Device: Micro-osteoperforations
control	No intervention	Conventional orthodontic treatment without any aid in tooth acceleration method / device

What is being measured

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

1. To compare the duration to align the lower labial segment (33-43), between regular and irregular review groups from the conventional (control group).
Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine
Measured: 5 months
2. To compare the duration to align the lower labial segment (33-43), between regular and irregular review groups from the micro-osteoperforations group.
Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine
Measured: 5 months
3. To compare the duration to align the lower labial segment (33-43), between micro-osteoperforations and control group in the regular review group.
Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine
Measured: 5 months
4. To compare the duration to align the lower labial segment (33-43), between micro-osteoperforations and control group in the irregular review group.
Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine
Measured: 5 months

Secondary outcomes (3)

Total volume of root resorption with micro-osteoperforations group vs the control group
Total volume of root resorption in cubic millimeter (mm3) using 3D Cone Beam CT imaging scanner compare at baseline and end of LLS alignment
Measured: 5 months
Gingival recession between micro-osteoperforations and control group.
Gingival recession assessed in millimetre (mm) from cement-enamel junction (CEJ) to free gingival margin using electric digital calliper with an accuracy of 0.01mm, at baseline and end LLS alignment
Measured: 5 months
Black triangle between micro-osteoperforations and control group.
Presence of black triangle for interdental at baseline and end of LLS alignment
Measured: 5 months

Timeline

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

19 Nov 201814 Apr 2021

First posted25 Mar 2019
Study start19 Nov 2018
Primary completion14 Apr 2021
Study completion14 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for MalocclusionStudies 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
Model description: The start date of lower labial segment alignment (T1) was recorded after insertion of the lower 0.014'' NiTi archwire. Participants were reviewed every 6 weeks and repeated MOPs were performed for the MOP group until the completion of lower labial segment alignment (LLS), which is when the LII scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine. At the end of alignment stage, the date for completion of alignment was recorded (T2), from which the overall alignment time (OAT) in days, required to complete LLS alignment, were calculated. Measurements were done clinically using an electric digital caliper. At this point, perforations were stopped. Gingival recession and black triangle were then recorded and measured. Patients were referred for CBCT images to evaluate for root resorption.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03888560
Sponsor's protocol ID: DGD170005
Acronym: MOP
Status last verified: Oct 2021
First submitted: 13 Mar 2019
Last updated: 27 Oct 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Teixeira CC, Khoo E, Tran J, Chartres I, Liu Y, Thant LM, Khabensky I, Gart LP, Cisneros G, Alikhani M. Cytokine expression and accelerated tooth movement. J Dent Res. 2010 Oct;89(10):1135-41. doi: 10.1177/0022034510373764. Epub 2010 Jul 16.
PubMed 20639508
Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
PubMed 24182579
Alkebsi A, Al-Maaitah E, Al-Shorman H, Abu Alhaija E. Three-dimensional assessment of the effect of micro-osteoperforations on the rate of tooth movement during canine retraction in adults with Class II malocclusion: A randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):771-785. doi: 10.1016/j.ajodo.2017.11.026.
PubMed 29853235
Sivarajan S, Doss JG, Papageorgiou SN, Cobourne MT, Wey MC. Mini-implant supported canine retraction with micro-osteoperforation: A split-mouth randomized clinical trial. Angle Orthod. 2019 Mar;89(2):183-189. doi: 10.2319/011518-47.1. Epub 2018 Oct 29.
PubMed 30372126
Attri S, Mittal R, Batra P, Sonar S, Sharma K, Raghavan S, Rai KS. Comparison of rate of tooth movement and pain perception during accelerated tooth movement associated with conventional fixed appliances with micro-osteoperforations - a randomised controlled trial. J Orthod. 2018 Dec;45(4):225-233. doi: 10.1080/14653125.2018.1528746. Epub 2018 Oct 3.
PubMed 30281397

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malocclusion trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Duration Of Lower Labial Segment Alignment With Repeated Micro-Osteoperforations: Randomised Controlled Clinical Trial
ClinicalTrials.gov ID: NCT03888560
Acronym / sponsor ID: MOP / DGD170005
Conditions: Malocclusion
Keywords: micro-osteperforation, orthodontic tooth movement, treatment duration
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: University of MalayaUniversity, hospital or other
Study start: 19 Nov 2018 (actual)
Primary completion: 14 Apr 2021 (actual)
Study completion: 14 Apr 2021 (actual)
First posted: 25 Mar 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: The start date of lower labial segment alignment (T1) was recorded after insertion of the lower 0.014'' NiTi archwire. Participants were reviewed every 6 weeks and repeated MOPs were performed for the MOP group until the completion of lower labial segment alignment (LLS), which is when the LII scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine. At the end of alignment stage, the date for completion of alignment was recorded (T2), from which the overall alignment time (OAT) in days, required to complete LLS alignment, were calculated. Measurements were done clinically using an electric digital caliper. At this point, perforations were stopped. Gingival recession and black triangle were then recorded and measured. Patients were referred for CBCT images to evaluate for root resorption.

Arm	Type	Receives
Micro-osteoperforations	Experimental	Device: Micro-osteoperforationsLower arch, 2 MOPs vertically at interdental area bilaterally mesial to lower 6's ; mesial to lower 1st premolar; mesial to lower 2's and between the lower 1's..The start date of lower labial segment alignment (T1) was recorded after insertion of the lower 0.014'' NiTi archwire. Participants were reviewed every 6 weeks and repeated MOPs were performed for the experimental group until the completion of lower labial segment alignment (LLS), which is when the Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine.
control	No intervention	–Conventional orthodontic treatment without any aid in tooth acceleration method / device

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Gender : Male and Female
Age range : ≥ 18years to 45 years old
Crowding of 3mm - 7mm on lower labial segment (lower right canine to lower left canine) which does not require extractions in the lower arch
Class II div I Incisor relationship with extraction of both upper 1st premolars
Maximum anchorage control with temporary anchorage device ( TAD) , with Molar Class II (¼ to full unit) malocclusion

Key exclusion criteria (9 listed)

Smokers
Distally angulated canines
History of trauma (crown fracture or avulsion and re-implantation) , endodontic treatment
Missing permanent mandibular anterior teeth ( Hypodontia) / Retained deciduous teeth in mandibular anterior area
Habits eg: fingernails biting , toothpick user , using hard toothbrush

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-osteoperforationsMOPs will be performed using SIA Excalibur Mini-Implant with dimension 1.6 mm in width and length of 6 mm, screw 3 mm depth into buccal bone of intervention sites	Device	Micro-osteoperforations

Primary outcome

1. To compare the duration to align the lower labial segment (33-43), between regular and irregular review groups from the conventional (control group).
Time frame: 5 months
Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine
2. To compare the duration to align the lower labial segment (33-43), between regular and irregular review groups from the micro-osteoperforations group.
Time frame: 5 months
Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine
3. To compare the duration to align the lower labial segment (33-43), between micro-osteoperforations and control group in the regular review group.
Time frame: 5 months
Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine
4. To compare the duration to align the lower labial segment (33-43), between micro-osteoperforations and control group in the irregular review group.
Time frame: 5 months
Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine

3 secondary outcomes

Total volume of root resorption with micro-osteoperforations group vs the control group
Time frame: 5 months
Gingival recession between micro-osteoperforations and control group.
Time frame: 5 months
Black triangle between micro-osteoperforations and control group.
Time frame: 5 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 27 Oct 2021.
Background: PubMed 20639508Teixeira CC, Khoo E, Tran J, Chartres I, Liu Y, Thant LM, Khabensky I, Gart LP, Cisneros G, Alikhani M. Cytokine expression and accelerated tooth movement. J Dent Res. 2010 Oct;89(10):1135-41. doi: 10.1177/0022034510373764. Epub 2010 Jul 16.
Background: PubMed 24182579Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
Background: PubMed 29853235Alkebsi A, Al-Maaitah E, Al-Shorman H, Abu Alhaija E. Three-dimensional assessment of the effect of micro-osteoperforations on the rate of tooth movement during canine retraction in adults with Class II malocclusion: A randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):771-785. doi: 10.1016/j.ajodo.2017.11.026.
Background: PubMed 30372126Sivarajan S, Doss JG, Papageorgiou SN, Cobourne MT, Wey MC. Mini-implant supported canine retraction with micro-osteoperforation: A split-mouth randomized clinical trial. Angle Orthod. 2019 Mar;89(2):183-189. doi: 10.2319/011518-47.1. Epub 2018 Oct 29.
Background: PubMed 30281397Attri S, Mittal R, Batra P, Sonar S, Sharma K, Raghavan S, Rai KS. Comparison of rate of tooth movement and pain perception during accelerated tooth movement associated with conventional fixed appliances with micro-osteoperforations - a randomised controlled trial. J Orthod. 2018 Dec;45(4):225-233. doi: 10.1080/14653125.2018.1528746. Epub 2018 Oct 3.
Individual participant dataSharing planned: No

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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.

Nik Nuraini Nik Azmin principal investigator

University of Malaya

lorretha p ringgingon principal investigator

faculty of dentistry university of malaya

Saritha Sivarajan study director

faculty of dentistry 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-osteoperforations in people with Malocclusion, 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 9 inclusion and 9 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 27 Oct 2021. 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?

1. To compare the duration to align the lower labial segment (33-43), between regular and irregular review groups from the conventional (control group). (time frame: 5 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03888560, which also lists 5 linked publications.

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 27 Oct 2021.