Dental MalocclusionsNCT04383600
Flapless Mops for Acceleration of Canine Retraction
A study testing Micro-osteoperforation in people with Dental Malocclusions and Angle Class II, Division 1, run by Ahmed Akram Elawady at 1 site in Egypt.
Trial summary
The aim of the present clinical study was directed to evaluate the effectiveness of micro-osteoperforations on the rate of canine retraction; in addition, the potential risk for root resorption during maxillary canine retraction. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Dental Malocclusions, Angle Class II, Division 1, Bimaxillary Protrusion
- 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
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 5 Jun 2019
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- An age ranged between 14 to 18 years.
- Class II division 1 malocclusion or Class I bimaxillary protrusion with mild or no crowding. Wherever crowding was present, it was symmetrical on both sides of the arch.
- Patients who diagnosed to require extraction of at least maxillary first premolars bilaterally as a part of their treatment plan.
- Complete permanent dentition (3rdmolars were not included).
- Good oral and general health.
- No history of periodontal problems.
- No therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances during the study period.
Who cannot join
- Blocked out or impacted maxillary canines.
- Transverse and/or vertical skeletal dysplasia or craniofacial anomalies.
- Systemic diseases or regular use of medications that could interfere with orthodontic treatment.
- Previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Micro-osteoperforations on the Rate of Maxillary Canine Retraction: A Randomized Controlled Trial
The aim of the present clinical study was directed to evaluate the effectiveness of micro-osteoperforations on the rate of canine retraction; in addition, the potential risk for root resorption during maxillary canine retraction.
Read the detailed description
The aim of the present clinical study was directed to evaluate the effectiveness of micro-osteoperforations on the rate of canine retraction; in addition, the potential risk for root resorption during maxillary canine retraction.
This study was conducted on a total sample of 24 canines of 12 patients, 8 females and 4 males, with mean age was 16.17 ± 2.29 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.
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 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 until complete 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-osteoperforation
- Keywords
- MOPs, micro-osteoperforation, acceleration, orthodontic tooth movement
- 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-osteoperforationProcedure 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 |
|---|---|---|
| Conventional side | No intervention | Canine retraction was commenced without micro-osteoperforations. |
| Mops side | Experimental | Canine retraction was commenced with micro-osteoperforations. Receives: Procedure: Micro-osteoperforation |
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 4 weeks till complete space closure (complete canine retraction).
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 complete space closure up to 6 months
Canine root length changes
The CBCT scans were taken before orthodontic treatment and after complete space closure (canine retraction) to be analyzed for assessment of Canine root length changes.
The root length was measured along the axis of the root, perpendicular to a line connecting the buccal and palatal cemento-enamel junction CEJ in sagittal view
Measured: change from start of orthodontic treatment until complete space closure up to 9 months
Secondary outcomes (1)
Anchorage loss of maxillary first permanent molars.
mesial movement of maxillary first permanent molars bilaterally was measured before orthodontic treatment and after complete space closure ( canine retraction) on CBCT scan which were taken before orthodontic treatment and after complete canine retraction The distance measured along perpendicular from distal surface of 1st permanent molar to Ptv plane
Measured: change from start of orthodontic treatment until complete space closure up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Sep 2017
- Primary completion15 May 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental MalocclusionsStudies 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
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Akram Elawady
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Akram Elawady, Al-Azhar University
- Investigators
- Ahmed El Awady, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383600
- Sponsor's protocol ID
- 100
- Status last verified
- May 2020
- First submitted
- 2 May 2020
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Micro-osteoperforations on the Rate of Maxillary Canine Retraction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04383600
- Acronym / sponsor ID
- 100
- Keywords
- MOPs, micro-osteoperforation, acceleration, orthodontic tooth movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ahmed Akram ElawadyUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 12 May 2020 (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 the present clinical study was directed to evaluate the effectiveness of micro-osteoperforations on the rate of canine retraction; in addition, the potential risk for root resorption during maxillary canine retraction.
Detailed description
The aim of the present clinical study was directed to evaluate the effectiveness of micro-osteoperforations on the rate of canine retraction; in addition, the potential risk for root resorption during maxillary canine retraction.
This study was conducted on a total sample of 24 canines of 12 patients, 8 females and 4 males, with mean age was 16.17 ± 2.29 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.
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 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 until complete 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional side | No intervention | –Canine retraction was commenced without micro-osteoperforations. |
| Mops side | Experimental | Procedure: Micro-osteoperforationCanine retraction was commenced with micro-osteoperforations. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- An age ranged between 14 to 18 years.
- Class II division 1 malocclusion or Class I bimaxillary protrusion with mild or no crowding. Wherever crowding was present, it was symmetrical on both sides of the arch.
- Patients who diagnosed to require extraction of at least maxillary first premolars bilaterally as a part of their treatment plan.
- Complete permanent dentition (3rdmolars were not included).
- Good oral and general health.
Key exclusion criteria (4 listed)
- Blocked out or impacted maxillary canines.
- Transverse and/or vertical skeletal dysplasia or craniofacial anomalies.
- Systemic diseases or regular use of medications that could interfere with orthodontic treatment.
- 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-osteoperforationAlso: Mopsthree flapless micro-osteoperforations was performed distal to the maxillary canine before starting retraction. | Procedure or surgery | Mops side |
Primary outcome
Rate of canine retraction
Time frame: change from start of canine retraction until complete space closure up to 6 months
Clinically, patients were evaluated immediately before canine retraction and every 4 weeks till complete space closure (complete canine retraction). 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.
Canine root length changes
Time frame: change from start of orthodontic treatment until complete space closure up to 9 months
The CBCT scans were taken before orthodontic treatment and after complete space closure (canine retraction) to be analyzed for assessment of Canine root length changes. The root length was measured along the axis of the root, perpendicular to a line connecting the buccal and palatal cemento-enamel junction CEJ in sagittal view
1 secondary outcome
Anchorage loss of maxillary first permanent molars.
Time frame: change from start of orthodontic treatment until complete space closure up to 9 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 12 May 2020.
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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.
Ahmed El Awady principal investigator
Al-Azhar 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-osteoperforation in people with Dental Malocclusions and Angle Class II, Division 1, run by Ahmed Akram Elawady 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 7 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 12 May 2020. 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 complete space closure up to 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 May 2020.