Bimaxillary ProtrusionNCT04868721
Evaluation of Two Approaches of Micro-osteoperforations (MOPs) During Orthodontic Canine Retraction
A study testing micro-osteoperforations in people with Bimaxillary Protrusion and Angle Class II, Division 1, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of this clinical prospective study will be directed to evaluate two approaches of micro-osteoperforations (MOPs) during orthodontic canine retraction. Read more about this study
- Who is it for?
- Ages 15 to 22 years
- Conditions the study is for
- Bimaxillary Protrusion, Angle Class II, Division 1, Dental Malocclusions
- What is being tested?
- micro-osteoperforations
- 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
- 11 Nov 2020to 14 Jun 2022
- 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 15 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Patient diagnosed to have an indication for non-extraction approach.
- Poor oral hygiene or periodontally compromised patient.
- Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
- Previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Two Approaches of Micro-osteoperforations During Orthodontic:A Prospective Clinical Study
The aim of this clinical prospective study will be directed to evaluate two approaches of micro-osteoperforations (MOPs) during orthodontic canine retraction.
Read the detailed description
The aim of the present clinical study was directed to evaluate the effectiveness of two approaches of micro-osteoperforations (MOPs) during orthodontic canine retraction.
This study was conducted on a total sample of 36 canines of 18 patients, 15-22 years old who required therapeutic extraction of maxillary 1st premolars and canine retraction. They were selected randomly from the Outpatient Clinic, Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt.
they were randamly dived into two groups:as follows: Group I: include 9 patients , MOPs were performed for one time only on one side before retraction.
Group II: include 9 patients , MOPs were performed on repeated basis on one side.
Both maxillary canines, in each patient, were randomly assigned to either an experimental side or the control side in a simple split-mouth design. In the experimental side, micro-osteoperforations was performed distal to the maxillary canine at equal distance between maxillary canine and 2nd premolar before starting retraction, while the canines in the contralateral control side were retracted without micro-osteoperforations.
Extraction was done at the start of the treatment, and before fitting of the orthodontic appliance. Then upper dental arches were leveled and aligned using conventional sequences of wires.
Three flapless micro-osteoperforations was performed by using orthodontic miniscrews distal to the maxillary canines in the experimental side before starting retraction. Each perforation was 1.6 mm in diameter and 3-4 mm depth into the bone. Canines were completely retracted on 0.016 × 0.022 ̋ stainless steel wires by using closed coil spring delivered 150 gm force.
Patients were followed up every 28 days for 4 months of canine retraction. Routine orthodontic records were obtained for each patient before treatment.
Additionally, a full skull CBCT images were taken before treatment and immediately after canine retraction.
The rate of canine retraction was assessed clinically; in addition, cone beam CT (CBCT) scans were used to assess the amount of canine retraction root length changes. Also anchorage loss of first permanent molars were assessed.
The treatment results were compared clinically and radiographically (CBCT).
- Being tested
- micro-osteoperforations
- Keywords
- Micro-osteoperforation, Accelerated orthodontics, Tooth movement, Canine retraction
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-osteoperforationsProcedure or surgery
Also called MOPs
three flapless micro-osteoperforations was performed distal to the maxillary canine before starting retraction.
| Study group | Role | What they receive |
|---|---|---|
| control side | No intervention | Conventional side Canine retraction was commenced without micro-osteoperforations. |
| single Micro-osteoperforations side | Experimental | Three flapless micro-osteoperforations (MOPs) was performed for one time only distal to the maxillary canine before starting retraction. Receives: Procedure: micro-osteoperforations |
| Multiple Micro-osteoperforations side | Experimental | Three flapless micro-osteoperforations (MOPs) was performed on repeated basis distal to the maxillary canine evey 28 days before canine retraction. Receives: Procedure: micro-osteoperforations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of canine retraction
clinically, patients were evaluated immediately before canine retraction and every 28days until for months.
It was based on measuring the distance between the contact points on the distal surface of the canines and the contact points on mesial surface of the second premolars.
Measured: change from start of canine retraction until 4 months .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start11 Nov 2020
- Primary completion14 Feb 2022
- Study completion14 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bimaxillary ProtrusionStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassem Atef Hassan Ahmed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868721
- Sponsor's protocol ID
- 535/1147
- Status last verified
- Jun 2022
- First submitted
- 25 Apr 2021
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Approaches of Micro-osteoperforations During Orthodontic:A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04868721
- Acronym / sponsor ID
- 535/1147
- Keywords
- Micro-osteoperforation, Accelerated orthodontics, Tooth movement, Canine retraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 3 May 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 aim of this clinical prospective study will be directed to evaluate two approaches of micro-osteoperforations (MOPs) during orthodontic canine retraction.
Detailed description
The aim of the present clinical study was directed to evaluate the effectiveness of two approaches of micro-osteoperforations (MOPs) during orthodontic canine retraction.
This study was conducted on a total sample of 36 canines of 18 patients, 15-22 years old who required therapeutic extraction of maxillary 1st premolars and canine retraction. They were selected randomly from the Outpatient Clinic, Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt.
they were randamly dived into two groups:as follows: Group I: include 9 patients , MOPs were performed for one time only on one side before retraction.
Group II: include 9 patients , MOPs were performed on repeated basis on one side.
Both maxillary canines, in each patient, were randomly assigned to either an experimental side or the control side in a simple split-mouth design. In the experimental side, micro-osteoperforations was performed distal to the maxillary canine at equal distance between maxillary canine and 2nd premolar before starting retraction, while the canines in the contralateral control side were retracted without micro-osteoperforations.
Extraction was done at the start of the treatment, and before fitting of the orthodontic appliance. Then upper dental arches were leveled and aligned using conventional sequences of wires.
Three flapless micro-osteoperforations was performed by using orthodontic miniscrews distal to the maxillary canines in the experimental side before starting retraction. Each perforation was 1.6 mm in diameter and 3-4 mm depth into the bone. Canines were completely retracted on 0.016 × 0.022 ̋ stainless steel wires by using closed coil spring delivered 150 gm force.
Patients were followed up every 28 days for 4 months of canine retraction. Routine orthodontic records were obtained for each patient before treatment.
Additionally, a full skull CBCT images were taken before treatment and immediately after canine retraction.
The rate of canine retraction was assessed clinically; in addition, cone beam CT (CBCT) scans were used to assess the amount of canine retraction root length changes. Also anchorage loss of first permanent molars were assessed.
The treatment results were compared clinically and radiographically (CBCT).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control side | No intervention | –Conventional side Canine retraction was commenced without micro-osteoperforations. |
| single Micro-osteoperforations side | Experimental | Procedure: micro-osteoperforationsThree flapless micro-osteoperforations (MOPs) was performed for one time only distal to the maxillary canine before starting retraction. |
| Multiple Micro-osteoperforations side | Experimental | Procedure: micro-osteoperforationsThree flapless micro-osteoperforations (MOPs) was performed on repeated basis distal to the maxillary canine evey 28 days before canine retraction. |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Patient diagnosed to have an indication for non-extraction approach.
- Poor oral hygiene or periodontally compromised patient.
- Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
- Previous orthodontic treatment.
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-osteoperforationsAlso: MOPsthree flapless micro-osteoperforations was performed distal to the maxillary canine before starting retraction. | Procedure or surgery | Multiple Micro-osteoperforations side, single Micro-osteoperforations side |
Primary outcome
Rate of canine retraction
Time frame: change from start of canine retraction until 4 months .
clinically, patients were evaluated immediately before canine retraction and every 28days until for months. It was based on measuring the distance between the contact points on the distal surface of the canines and the contact points on mesial surface of the second premolars.
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 16 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bimaxillary Protrusion and Angle Class II, Division 1, run by Al-Azhar 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 0 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 16 Jun 2022. 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?
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?
Rate of canine retraction (time frame: change from start of canine retraction until 4 months .). 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 16 Jun 2022.