Tooth Position AnomaliesNCT04778241
Effects of Mini Implant Facilitated Micro-osteoperforations on the Alignment of Mandibular Anterior Crowding
A study testing Micro-osteoperforation in people with Tooth Position Anomalies, run by University of Baghdad at 1 site in Iraq.
Trial summary
The primary aim of the present study is to evaluate the the efficacy of micro-osteoperforation (MOPs) perfomed by mini-implant (MI) screw In improving alignment of mandibular anterior teeth Read more about this study
- Who is it for?
- Ages 17 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Position Anomalies
- What is being tested?
- Micro-osteoperforation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jun 2020to 15 Mar 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 17 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age range between 17-25years
- Non-extraction treatment in the mandibular arch
- Presence of full complement of dentition from first molar to first molar
- Mandibular anterior irregularity index between 4-6 mm
- Patient with healthy periodontium and no attachment loss of >2 mm
Who cannot join
- Previous orthodontic treatment
- Presence of primary or missing permanent teeth in the mandibular anterior area
- Medical problems that affect tooth movement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mini Implant Facilitated Micro-osteoperforations on the Alignment of Mandibular Anterior Crowding: A Randomized Controlled Clinical Trial
The primary aim of the present study is to evaluate the the efficacy of micro-osteoperforation (MOPs) perfomed by mini-implant (MI) screw In improving alignment of mandibular anterior teeth
Read the detailed description
Primarily the present study is designed to evaluate the efficacy of micro-osteoperation (MOPs) perfomed by mini-implant (MI) screw In improving alignment of mandibular anterior teeth. Additionally, the possibility of inducing root resorption, and patient perception of pain during the initial phase of treatment.
Subjects and Methods: Orthodontic patients aged 17-25 years old, non-extraction treatment with lower anterior crowding of 4-6 mm using Little's irregularity index. Outcome measures included the amount of crowding using Little's irregularity index (LII), apical root resorption, and pain perception. The effectiveness of alignment will be tested using t-test, while root resorption and pain perception will be tested by the Mann-Whitney U test, and Wilcoxon signed-rank test (P<0.05).
- Conditions
- Tooth Position Anomalies
- Being tested
- Micro-osteoperforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-osteoperforationProcedure or surgery
Also called MOP
Mini-implant facilitated micro-osteoperforation (MOPs) were placed in the experimental group before placing the initial leveling arch wire. MOPs were placed at three sites i.e., interproximally between mandibular canine and lateral incisor on both sides and between central incisors in the midline on labial aspect of mandible.
| Study group | Role | What they receive |
|---|---|---|
| Micro-Osteoperforation group | Experimental | All the participants bonded by the care provider with 0.022 inch MBT prescription appliance (Ortho TechanologyTM,USA). Mini-implant facilitated micro-osteoperforation (MOPs) were placed in the experimental group before placing the initial leveling arch wire. MOPs were placed at three sites i.e., interproximally between mandibular canine and lateral incisor on both sides and between central incisors in the midline on labial aspect of mandible. Receives: Procedure: Micro-osteoperforation |
| Control group | No intervention | All the participants in this group bonded by the principal investigator with 0.022-inch slot MBT prescription appliance (Ortho TechanologyTM,USA). No micro-osteoperforation was used in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alignment efficiency
3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3D program (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished.
Measured: 4 weeks
Alignment efficiency
3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3D program (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished.
Measured: 8 weeks
Alignment efficiency
3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3D program (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished.
Measured: 12 weeks
Secondary outcomes (2)
The amount of Root resorption
The amount of root resorption was measured at the start of treatment and after 12 weeks, the length of the root was recoded at these time intervals. Radiographic films were positioned using a customized sensor holder for the lower anterior teeth with a 7cm film-cone distance using long cone paralleling technique. The radiographs were made at 70kV and 8mA DC with an exposure of 0.25 seconds.
Measured: 12 weeks
Pain perception
Evaluations of pain/discomfort was made in the evening on a daily basis over the first 7 days after bonding using a 10-point visual analog scale (VAS) of 10cm length. The highest pain level experienced should be reported by each patient. The recording sheet was received by all the patients on the day of bonding, it included seven visual analog scales (one for each day) and the patients were given oral instructions on how to finish the VAS by marking the point on the line which supposed to represent the maximum pain that they felt per day, with 0 refers to "no pain" and 10 refers to "intolerable pain". Patients were reminded daily by a phone call or a text message to mark the recording sheet and to bring it on their next appointment.
Measured: first 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Jun 2020
- Primary completion1 Feb 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth Position AnomaliesStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mushriq F. Abid, University of Baghdad
- Investigators
- Mushriq Abid, MSc, PhD, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778241
- Sponsor's protocol ID
- MOP76
- Status last verified
- Apr 2021
- First submitted
- 19 Feb 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al-Attar A, Nissan L, Almuzian M, Abid M. Effect of mini-implant facilitated micro-osteoperforations on the alignment of mandibular anterior crowding: A randomised controlled clinical trial. J Orthod. 2022 Dec;49(4):379-387. doi: 10.1177/14653125221099038. Epub 2022 May 15.
PubMed 35575069
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mini Implant Facilitated Micro-osteoperforations on the Alignment of Mandibular Anterior Crowding: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04778241
- Acronym / sponsor ID
- MOP76
- Conditions
- Tooth Position Anomalies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 3 Mar 2021 (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.
The primary aim of the present study is to evaluate the the efficacy of micro-osteoperforation (MOPs) perfomed by mini-implant (MI) screw In improving alignment of mandibular anterior teeth
Detailed description
Primarily the present study is designed to evaluate the efficacy of micro-osteoperation (MOPs) perfomed by mini-implant (MI) screw In improving alignment of mandibular anterior teeth. Additionally, the possibility of inducing root resorption, and patient perception of pain during the initial phase of treatment.
Subjects and Methods: Orthodontic patients aged 17-25 years old, non-extraction treatment with lower anterior crowding of 4-6 mm using Little's irregularity index. Outcome measures included the amount of crowding using Little's irregularity index (LII), apical root resorption, and pain perception. The effectiveness of alignment will be tested using t-test, while root resorption and pain perception will be tested by the Mann-Whitney U test, and Wilcoxon signed-rank test (P<0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micro-Osteoperforation group | Experimental | Procedure: Micro-osteoperforationAll the participants bonded by the care provider with 0.022 inch MBT prescription appliance (Ortho TechanologyTM,USA). Mini-implant facilitated micro-osteoperforation (MOPs) were placed in the experimental group before placing the initial leveling arch wire. MOPs were placed at three sites i.e., interproximally between mandibular canine and lateral incisor on both sides and between central incisors in the midline on labial aspect of mandible. |
| Control group | No intervention | –All the participants in this group bonded by the principal investigator with 0.022-inch slot MBT prescription appliance (Ortho TechanologyTM,USA). No micro-osteoperforation was used in this group. |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age range between 17-25years
- Non-extraction treatment in the mandibular arch
- Presence of full complement of dentition from first molar to first molar
- Mandibular anterior irregularity index between 4-6 mm
- Patient with healthy periodontium and no attachment loss of >2 mm
Key exclusion criteria (3 listed)
- Previous orthodontic treatment
- Presence of primary or missing permanent teeth in the mandibular anterior area
- Medical problems that affect tooth movement.
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: MOPMini-implant facilitated micro-osteoperforation (MOPs) were placed in the experimental group before placing the initial leveling arch wire. MOPs were placed at three sites i.e., interproximally between mandibular canine and lateral incisor on both sides and between central incisors in the midline on labial aspect of mandible. | Procedure or surgery | Micro-Osteoperforation group |
Primary outcome
Alignment efficiency
Time frame: 4 weeks
3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3D program (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished.
Alignment efficiency
Time frame: 8 weeks
3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3D program (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished.
Alignment efficiency
Time frame: 12 weeks
3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3D program (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished.
2 secondary outcomes
The amount of Root resorption
Time frame: 12 weeks
Pain perception
Time frame: first 7 days
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 12 Apr 2021.
- Derived from this study: PubMed 35575069Al-Attar A, Nissan L, Almuzian M, Abid M. Effect of mini-implant facilitated micro-osteoperforations on the alignment of mandibular anterior crowding: A randomised controlled clinical trial. J Orthod. 2022 Dec;49(4):379-387. doi: 10.1177/14653125221099038. Epub 2022 May 15.
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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.
Mushriq Abid, MSc, PhD principal investigator
University of Baghdad
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 Tooth Position Anomalies, run by University of Baghdad at 1 site in Iraq.
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 5 inclusion and 3 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 12 Apr 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 Iraq. 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?
Alignment efficiency (time frame: 4 weeks). The study lists 3 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 NCT04778241, 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 12 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.