MicroosteoperforationsNCT06497244
Evaluation of the Effect of Micro-osteoperforation on the Rate of Bone Anchored Molar Distalization
A study testing micro osteo-perforation in people with Microosteoperforations, run by Cairo University at 1 site in Egypt.
Trial summary
The primary aim of the current study was to evaluate three dimensionally, using digital models and cone beam computed tomography imaging, the effect of micro-osteoperforations on the rate of tooth movement in the first molar distalization. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microosteoperforations
- What is being tested?
- micro osteo-perforation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2023to 30 Dec 2024
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult patients
- Skeletal Class I or mild Class II relationship
- Dental class II bilaterally (non-extraction cases)
- Full permanent dentition including 2nd maxillary molars
- Good oral hygiene
- Medically free
Who cannot join
- Systemic diseases that may interfere with the treatment
- Use of any medications that might have affected the biology of tooth movement
- unilateral Class II molar relationship
- extreme skeletal Class II relationship (ANB >7°)
- periodontal disease or alveolar bone loss
- Patients with dental anomalies in maxillary 1st molar
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university
Cairo
faculty of dentistry Cairo university, 0020223634965
About this study
Official title: Evaluation of the Effect of Micro-osteoperforation on the Rate of Bone Anchored Molar Distalization: a Split-mouth Randomized Controlled Clinical Trial
The primary aim of the current study was to evaluate three dimensionally, using digital models and cone beam computed tomography imaging, the effect of micro-osteoperforations on the rate of tooth movement in the first molar distalization.
Read the detailed description
The design of this randomized controlled clinical trial is a parallel group, two arms trial
- Preparatory phase
- Self-drilling mini-screws will be placed buccally between upper 2nd premolar and 1st molar bilaterally in the last NiTi wire insertion visit.
- After the completion of levelling and alignment phase an intra oral scan will be made for the upper arch and a rigid stainless-steel retraction arch wire 0.017" x 0.025" will be inserted.
- The patient will then be referred to the radiology center and a pre-retraction cone beam computed tomography (CBCT) image will be taken for the maxillary arch (T0).
- Experimental phase
- Subjects will receive MOPs randomly to either the left or right maxillary molar buccal alveolar regions. MOPs will be performed at the first day of the distalization treatment (T0) and will repeated every 2 months.
- Molar distalization will started immediately after performing the MOPs using sliding jig distalizer.
- The force will be applied to the mini-screw with the sliding jig mechanics on average 300 gm using Nickel-titanium closing coil springs.
- Before leaving the clinic, the patient will be asked to:
- Use chlorhexidine three times per day for 3 days after MOP applications.
- avoid using pain killers (except Panadol when needed).
- fill in a Numeric pain rating scale.
- Follow up phase
- Follow up visits will be scheduled every 4 weeks for reactivation coil spring and check TADs stability.
- An intra oral scan for the upper arch will made every visit.
- The study time will be continued for 6 months (T1, T2, T3, T4, T5, T6).
- The same technique of MOP will be repeated after 2 and 4 months of follow up (T2,T4).
- After 6 months of follow up, the final dental model will made, and the patient will be referred to the same radiology center to acquire the post-distalization CBCT.
- Conditions
- Microosteoperforations
- Being tested
- micro osteo-perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro osteo-perforationProcedure or surgery
the patient will receive miniscrew micro osteo-perforation in one side every month with molar distalization and the other side the distalization without micro osteo-perforation
| Study group | Role | What they receive |
|---|---|---|
| micro osteo-perforation side | Experimental | the patient will receive micro osteo-perforation in one side Computer generated random numbers will generated using Microsoft Office Excel sheet by a person who was not involved in the clinical trial. Because of the split mouth design, the right sides of patients will randomly be assigned to one of the two groups (MOPs or control). Then, the left sides will automatically be assigned to the alternative group. Receives: Procedure: micro osteo-perforation |
| no micro osteo-perforation side | No intervention | the other side without micro osteo-perforation |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of molar distalization
Incremental rate of molar distalization every month by intra oral scan superimposition
Measured: 6 months
total molar distalization distance by mm between T6 and T0
Total distance moved by the molar after 6 months by intra oral scan superimposition and measure the linear difference in position 1st molar between T6 and T0 by mm
Measured: 6 months
Secondary outcomes (5)
The effect of MOPs on Maxillary 1st molar tipping by degrees between T6 and T0
comparing the pre- \& post- distalization CBCT and measure the angular change in the 1st molar long axis tipping by degree between T6 and T0
Measured: 6 months
The effect of MOPs on Maxillary 1st molar rotation by degrees between T6 and T0
comparing the pre- \& post- distalization digital models and CBCT and measure the angular change in the 1st molar long axis rotation by degree between T6 and T0
Measured: 6 months
The effect of MOPs on Maxillary 1st molar vertical movement by mm between T6 and T0
comparing the pre- \& post- distalization CBCT and measure the linear change in the 1st molar vertical position by mm between T6 and T0
Measured: 6 months
The effect of MOPs on 1st molar root resorption level by mm between T6 and T0
comparing the pre- \& post- distalization CBCT and measure the amount of root resorption of 1st molar roots by mm between T6 and T0
Measured: 6 months
Detecting any Pain or discomfort caused by the micro-osteoperforations using Numeric pain rating scale
using Numeric Pain Rating Scale filled by the patient with minimum value is zero and maximum value 10 (the higher score mean worse outcome)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start10 Sep 2023
- Primary completion10 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicroosteoperforationsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Model description
- Subjects will receive MOPs randomly to either the left or right maxillary molar buccal alveolar regions. MOPs will be performed at the first day of the distalization treatment (T0) and will repeated every 2 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed essam, Cairo University
- Investigators
- Fatma Abdou, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497244
- Sponsor's protocol ID
- MOPD-CU-2022-11-15
- Status last verified
- Jul 2024
- First submitted
- 24 Jun 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Micro-osteoperforation on the Rate of Bone Anchored Molar Distalization: a Split-mouth Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06497244
- Acronym / sponsor ID
- MOPD-CU-2022-11-15
- Conditions
- Microosteoperforations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 11 Jul 2024 (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 current study was to evaluate three dimensionally, using digital models and cone beam computed tomography imaging, the effect of micro-osteoperforations on the rate of tooth movement in the first molar distalization.
Detailed description
The design of this randomized controlled clinical trial is a parallel group, two arms trial
- Preparatory phase
- Self-drilling mini-screws will be placed buccally between upper 2nd premolar and 1st molar bilaterally in the last NiTi wire insertion visit.
- After the completion of levelling and alignment phase an intra oral scan will be made for the upper arch and a rigid stainless-steel retraction arch wire 0.017" x 0.025" will be inserted.
- The patient will then be referred to the radiology center and a pre-retraction cone beam computed tomography (CBCT) image will be taken for the maxillary arch (T0).
- Experimental phase
- Subjects will receive MOPs randomly to either the left or right maxillary molar buccal alveolar regions. MOPs will be performed at the first day of the distalization treatment (T0) and will repeated every 2 months.
- Molar distalization will started immediately after performing the MOPs using sliding jig distalizer.
- The force will be applied to the mini-screw with the sliding jig mechanics on average 300 gm using Nickel-titanium closing coil springs.
- Before leaving the clinic, the patient will be asked to:
- Use chlorhexidine three times per day for 3 days after MOP applications.
- avoid using pain killers (except Panadol when needed).
- fill in a Numeric pain rating scale.
- Follow up phase
- Follow up visits will be scheduled every 4 weeks for reactivation coil spring and check TADs stability.
- An intra oral scan for the upper arch will made every visit.
- The study time will be continued for 6 months (T1, T2, T3, T4, T5, T6).
- The same technique of MOP will be repeated after 2 and 4 months of follow up (T2,T4).
- After 6 months of follow up, the final dental model will made, and the patient will be referred to the same radiology center to acquire the post-distalization CBCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will receive MOPs randomly to either the left or right maxillary molar buccal alveolar regions. MOPs will be performed at the first day of the distalization treatment (T0) and will repeated every 2 months.
| Arm | Type | Receives |
|---|---|---|
| micro osteo-perforation side | Experimental | Procedure: micro osteo-perforationthe patient will receive micro osteo-perforation in one side Computer generated random numbers will generated using Microsoft Office Excel sheet by a person who was not involved in the clinical trial. Because of the split mouth design, the right sides of patients will randomly be assigned to one of the two groups (MOPs or control). Then, the left sides will automatically be assigned to the alternative group. |
| no micro osteo-perforation side | No intervention | –the other side without micro osteo-perforation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients
- Skeletal Class I or mild Class II relationship
- Dental class II bilaterally (non-extraction cases)
- Full permanent dentition including 2nd maxillary molars
- Good oral hygiene
Key exclusion criteria (6 listed)
- Systemic diseases that may interfere with the treatment
- Use of any medications that might have affected the biology of tooth movement
- unilateral Class II molar relationship
- extreme skeletal Class II relationship (ANB >7°)
- periodontal disease or alveolar 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 osteo-perforationthe patient will receive miniscrew micro osteo-perforation in one side every month with molar distalization and the other side the distalization without micro osteo-perforation | Procedure or surgery | micro osteo-perforation side |
Primary outcome
rate of molar distalization
Time frame: 6 months
Incremental rate of molar distalization every month by intra oral scan superimposition
total molar distalization distance by mm between T6 and T0
Time frame: 6 months
Total distance moved by the molar after 6 months by intra oral scan superimposition and measure the linear difference in position 1st molar between T6 and T0 by mm
5 secondary outcomes
The effect of MOPs on Maxillary 1st molar tipping by degrees between T6 and T0
Time frame: 6 months
The effect of MOPs on Maxillary 1st molar rotation by degrees between T6 and T0
Time frame: 6 months
The effect of MOPs on Maxillary 1st molar vertical movement by mm between T6 and T0
Time frame: 6 months
The effect of MOPs on 1st molar root resorption level by mm between T6 and T0
Time frame: 6 months
Detecting any Pain or discomfort caused by the micro-osteoperforations using Numeric pain rating scale
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: No
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.
Fatma Abdou, professor study chair
Cairo University
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 osteo-perforation in people with Microosteoperforations, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Jul 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Elsayed, PhD (00201064111810, mohamedessam4@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of molar distalization (time frame: 6 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 12 Jul 2024.