MalocclusionNCT02473471

Micro-osteoperforations and Tooth Movement

A study testing Micro-osteoperforation in people with Malocclusion, run by Jordan University of Science and Technology at 1 site in Jordan.

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

The purpose of this study is determine the effect the Microosteoperforation (MOPs) using the miniscrew on the rate tooth movement. Moreover, measurement of the level of the pain and pain's interference, the level of satisfaction and comfort using this protocol. Read more about this study

Who is it for?: Ages 16 to 26 yearsHealthy volunteers can take part
Conditions the study is for: Malocclusion
What is being tested?: Micro-osteoperforation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteJordan
Study dates: Apr 2015to Nov 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 to 26 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Male and female
between 16 to 26 years old
Class II Division 1 malocclusion or bimaxillary protrusion
Average Lower facial height and Mandibular plane angle
No systemic disease
Healthy periodontal condition
Non smoker
Probing depth less than 4 mm in all teeth

Who cannot join

Long-term use of any Medication
Poor oral hygiene
Low and high angle cases
Systemic disease
Evidence of bone loss
Active periodontal disease

Show all 15Show fewer

Smoker
Probing depth more than 4 mm in all teeth
Cephalometric analysis of the included subjects was performed at baseline including
Sella-Nasion to A Point Angle (SNA): Measure Description: Sella-Nasion-A point (SNA) indicates the horizontal position of the maxilla relative to the cranial base.
Sella-Nasion to B Point Angle (SNB): Sella-Nasion-B point (SNB) indicates the horizontal position of the mandible relative to the cranial base.
A point to B Point Angle (ANB): A point- Nasion-B point (ANB) indicates the skeletal relationship between the maxilla and mandible.
Maxillary mandibular plane angle (MM): The angle formed between the Maxillary Plane and Mandibular Plane. Maxillary Plane is the plane demonstrated by a line through the anterior and posterior nasal spines.A mandibular plane is a plane demonstrated by a line through the gonion and menton.
Lower anterior facial height(LAFH)
Upper incisor inclination: The angle between the maxillary plane and the axis of the maxillary incisors.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

Jordan University of Science and Technology
Irbid, 22110

Other trials in Jordan

About this study

Official title: Micro-osteoperforations and Tooth Movement: A Randomized Controlled Clinical Trial

Read the detailed description

This study will be randomized, split mouth design controlled trial with a 1:1 allocation ratio. One resident (A.A), calibrated by the main supervisor (S.M), will be reliable for recruiting the subjects, undertaking the orthodontic treatment under the supervision. The eligibility of the cases will be reevaluated by main supervisor (E.M) before the start of treatment.

Split mouth design will be utilized with MOPs that will be randomly assigned to the patients' left or right sides to eliminate the possibility of uneven occlusal forces because of habitual occlusion predominantly on 1 side and also the eliminate the biological variability between subjects. The allocation sequence will be concealed from the researcher (A.A) enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes with the participant's the name and date of birth are written before the intervention. Allocation concealment seeks to prevent selection bias, protects the assignment sequence until allocation.

A Ethical approval will be granted by Jordan University of science and technology research center, and permission will be given at postgraduate dental clinics at Jordan University of science and technology, Irbid, Jordan.

We hypothesized that 50% increased in rate of tooth movement in MOP group would produce a clinically significant difference. The sample size was calculated depend on a type I error frequency of 5%. According to the power analysis and assuming a large effect size difference between groups with 50% of acceleration rate of tooth movement, the power analysis yields a total sample size estimate of 44 samples at a conventional alpha-level (p = 0.05) and desired power (1 - β err prob) of 0.90, yielding 22 samples per group (means 22 patients that represent 22 MOP group and 22 Control group). Assuming an overall attrition rate of 15%, initial recruitment should target a total of 55 samples with 18 patients per group. All calculations were performed with the computer application G-Power (Erdfelder et al., 1996)

Conditions: Malocclusion
Being tested: Micro-osteoperforation
Keywords: Micro-Osteoperforation (MOPs), regional acceleratory phenomenon (RAP), Malocculsion
Medical subject headings: Malocclusion

What participants receive

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

Micro-osteoperforationDevice
Also called Selective alveolar decortication
Three Micro-osteoperforation (MOPs) will be performed distal to canine by Mini screw. Before the application of the MOPs, Patient will be asked to wash their mouth twice by chorhexidine for 1 minute.

Study groups in NCT02473471
Study group	Role	What they receive
MOP side	Experimental	Three small holes in cortical bone can be created by Miniscrews.Before application of the MOPs, Patient will be asked to wash their mouth twice by chlorhexidine for 1 minute. Local anesthesia will be given (2% lidocaine with 1:100,000 epinephrine). Microosteoperforation (MOPs) will be performed distal to canine. Receives: Device: Micro-osteoperforation
control side	No intervention	No intervention in the other side of maxilla (control side)

What is being measured

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

3D Digital Model Measurements of Canine Rate of Tooth Movement
The baseline 3D digital model was superimposed to 3D digital models of the 1st month to determine the anterioposterior displacement of canines.
Measured: Baseline to 1st month
3D Digital Model Measurements of Canine Rate of Tooth Movement
The baseline 3D digital model was superimposed to 3D digital models of 2nd month to determine the anterioposterior displacement of canines.
Measured: Baseline to 2nd month
3D Digital Model Measurements of Canine Rate of Tooth Movement
The baseline 3D digital model was superimposed to 3D digital models of 3rd month to determine the anterioposterior displacement of canines.
Measured: Baseline to 3rd month
Intra Oral Measurements of Canine Rate of Tooth Movement
Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.
Measured: Baseline to 1st month
Intra Oral Measurements of Canine Rate of Tooth Movement
Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.
Measured: Baseline to 2nd month
Intra Oral Measurements of Canine Rate of Tooth Movement
Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.
Measured: Baseline to 3 month

Secondary outcomes (8)

Root Resorption
It will be evaluated by taking periapical radiograph for canines before canine retraction and after 3 months period
Measured: Baseline to 3rd month
Pain Intensity
It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain.
Measured: within 7 days after the intervention
Pain Interference /Pain During Eating?
It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain.
Measured: within 7 days after the intervention
Pain Interference /Pain Interrupted Sleep
It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain.
Measured: within 7 days after the intervention
Pain Interference /Swelling of the Surgical Side
It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no swelling and 10 = worst swelling.
Measured: within 7 days after the intervention
Pain Interference /Discomfort
It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no discomfort and 10 = worst discomfort.
Measured: within 7 days after the intervention
Patient Satisfaction
It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = unsatisfied and 10 = most satisfaction.
Measured: After 7 days of MOP application
Menstrual Cycle
the relationship between the rate of tooth movement and Menstrual cycle
Measured: within 3 months

Timeline

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

Apr 2015Nov 2016

First posted16 Jun 2015 (estimated)
Study startApr 2015
Primary completionNov 2016
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)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
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02473471
Sponsor's protocol ID: JordanUST
Status last verified: Nov 2017
First submitted: 16 Apr 2015
Last updated: 28 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Upon request.

Publications

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

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 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Micro-osteoperforations and Tooth Movement: A Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT02473471
Acronym / sponsor ID: JordanUST
Conditions: Malocclusion
Keywords: Micro-Osteoperforation (MOPs), regional acceleratory phenomenon (RAP), Malocculsion
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Jordan University of Science and TechnologyUniversity, hospital or other
Study start: Apr 2015
Primary completion: Nov 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 16 Jun 2015 (estimated)
Results: Posted 22 Nov 2017

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: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
MOP side	Experimental	Device: Micro-osteoperforationThree small holes in cortical bone can be created by Miniscrews.Before application of the MOPs, Patient will be asked to wash their mouth twice by chlorhexidine for 1 minute. Local anesthesia will be given (2% lidocaine with 1:100,000 epinephrine). Microosteoperforation (MOPs) will be performed distal to canine.
control side	No intervention	–No intervention in the other side of maxilla (control side)

Who may qualify

Ages: 16 to 26 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

Male and female
between 16 to 26 years old
Class II Division 1 malocclusion or bimaxillary protrusion
Average Lower facial height and Mandibular plane angle
No systemic disease

Key exclusion criteria (15 listed)

Long-term use of any Medication
Poor oral hygiene
Low and high angle cases
Systemic disease
Evidence of bone loss

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-osteoperforationAlso: Selective alveolar decorticationThree Micro-osteoperforation (MOPs) will be performed distal to canine by Mini screw. Before the application of the MOPs, Patient will be asked to wash their mouth twice by chorhexidine for 1 minute.	Device	MOP side

Primary outcome

3D Digital Model Measurements of Canine Rate of Tooth Movement
Time frame: Baseline to 1st month
The baseline 3D digital model was superimposed to 3D digital models of the 1st month to determine the anterioposterior displacement of canines.
3D Digital Model Measurements of Canine Rate of Tooth Movement
Time frame: Baseline to 2nd month
The baseline 3D digital model was superimposed to 3D digital models of 2nd month to determine the anterioposterior displacement of canines.
3D Digital Model Measurements of Canine Rate of Tooth Movement
Time frame: Baseline to 3rd month
The baseline 3D digital model was superimposed to 3D digital models of 3rd month to determine the anterioposterior displacement of canines.
Intra Oral Measurements of Canine Rate of Tooth Movement
Time frame: Baseline to 1st month
Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.
Intra Oral Measurements of Canine Rate of Tooth Movement
Time frame: Baseline to 2nd month
Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.
Intra Oral Measurements of Canine Rate of Tooth Movement
Time frame: Baseline to 3 month
Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.

8 secondary outcomes

Root Resorption
Time frame: Baseline to 3rd month
Pain Intensity
Time frame: within 7 days after the intervention
Pain Interference /Pain During Eating?
Time frame: within 7 days after the intervention
Pain Interference /Pain Interrupted Sleep
Time frame: within 7 days after the intervention
Pain Interference /Swelling of the Surgical Side
Time frame: within 7 days after the intervention
Pain Interference /Discomfort
Time frame: within 7 days after the intervention
Patient Satisfaction
Time frame: After 7 days of MOP application
Menstrual Cycle
Time frame: within 3 months

Results and safety

Results posted to the registry on 22 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	35	32

Primary outcome: 3D Digital Model Measurements of Canine Rate of Tooth Movement

Time frame: Baseline to 1st month. Mean (Standard Deviation). Unit: mm

Measure	MOP Side n = 29	Control Side n = 29
Value	0.65 (0.26)	0.67 (0.34)

MOP Side vs Control Side: p = 0.77, t-test, 2 sided

Population analysed: Thirty-five subjects were randomized to receive MOP to either right or left sides with 1:1 allocation ratio. Three impressions were missing at first month due to alginate distortion.

Primary outcome: 3D Digital Model Measurements of Canine Rate of Tooth Movement

Time frame: Baseline to 2nd month. Mean (Standard Deviation). Unit: mm

Measure	MOP Side n = 31	Control Side n = 31
Value	1.36 (0.49)	1.28 (0.50)

MOP Side vs Control Side: p = 0.50, t-test, 2 sided

Population analysed: Thirty-five subjects were randomized to receive MOP to either right or left sides with 1:1 allocation ratio. only one impression was lost to be taken by a clinician at two months period.

Primary outcome: 3D Digital Model Measurements of Canine Rate of Tooth Movement

Time frame: Baseline to 3rd month. Mean (Standard Deviation). Unit: mm

Measure	MOP Side n = 32	Control Side n = 32
Value	1.93 (0.74)	1.88 (0.67)

MOP Side vs Control Side: p = 0.76, t-test, 2 sided

Primary outcome: Intra Oral Measurements of Canine Rate of Tooth Movement

Time frame: Baseline to 1st month. Mean (Standard Deviation). Unit: mm

Measure	MOP Side n = 31	Control Side n = 31
Value	1.23 (0.45)	1.17 (0.42)

MOP Side vs Control Side: p = 0.56, t-test, 2 sided

Population analysed: 32 subjects were analyzed to receive MOP to either right or left sides. Only one patient was lost to follow up at the first month time point.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months after intervention. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MOP Side	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Control Side	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Limitations and caveats (from the sponsor): 1. Effect of intervention on inflammatory markers was not evaluated. 2. Short-term clinical study with only 3-months follow up period. 3. Most of the study subjects were females (75%).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: 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.
Individual participant dataSharing planned: Yes. Upon request.

Related trials for Malocclusion

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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.

Amal A Alkebsi, MClinDent principal investigator

Jordan University of Science and Technology

Emad Al Maaitah, Ph.D. principal investigator

Jordan University of Science and Technology

Hisham Alshorman, Ph.D. principal investigator

Jordan University of Science and Technology

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 in people with Malocclusion, run by Jordan University of Science and Technology at 1 site in Jordan.

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 8 inclusion and 15 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 28 Nov 2017. 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 Jordan. 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?

Yes. Results are posted in the registry (first posted 22 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

3D Digital Model Measurements of Canine Rate of Tooth Movement (time frame: Baseline to 1st month). The study lists 6 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 NCT02473471, which also lists 1 linked publication.

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 28 Nov 2017.