Teeth Mesial DriftNCT03741504
Biological Anchorage With Selective Micro-osteoperforations (MOPs) in Canine Distalization
A study testing micro-osteoperforations (MOPs) in people with Teeth Mesial Drift and Bone Injury, run by Fundación Universitaria CIEO at 2 sites in Colombia.
Trial summary
To evaluate the effect of selective micro-osteoperforations (MOPs) on the amount of distal movement of the upper canine, the mesio-distal inclination of the canine and the messiah movement of the upper first molar. Read more about this study
- Who is it for?
- Ages 14 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Teeth Mesial Drift, Bone Injury, Orthodontic Pathological Resorption of External Root
- What is being tested?
- micro-osteoperforations (MOPs)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesColombia
- Study dates
- 2 Dec 2019to 9 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 14 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Class I or Class II malocclusion, division 1 (ANB: 0º-5º) with maxillary canines completely erupted with the need for canine retraction.
- Patients in the working phase with MBT prescription, slot 0.022" who have undergone extractions of bilateral upper premolar with more than three months before the time of upper canine distalization and with open space between the canine and the second premolar greater or equal to 3 mm.
- Age range between 14-40 years.
- Probing depth less than 4 mm in the upper canine
Who cannot join
- Patients with systemic disease.
- Medicated patients (prolonged use of antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, corticosteroids, systemic steroids, and calcium channel blockers).
- Pregnancy.
- Poor oral hygiene evident in more than two visits.
- Overjet ≥ 6 mm
- SN-GoGn ≥ 38 °
Show all 10Show fewer
- Radiographic evidence of moderate to severe bone loss.
- Subjects with active periodontal disease
- Patients who smoke.
- Individuals with inadequately treated endodontic problems in the study area.
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites
UniCIEO
Bogotá, DC, 110111
Universidad de Antioquia
Bogotá, DC, 110111
About this study
Official title: Biological Anchorage With Selective Micro-osteroperforations (MOPs) in Canine Distalization
To evaluate the effect of selective micro-osteoperforations (MOPs) on the amount of distal movement of the upper canine, the mesio-distal inclination of the canine and the messiah movement of the upper first molar.
Methods: Clinical trial with Split mouth design in 35 orthodontic patients with bilateral extraction of the upper first premolar, each upper canine will be randomly assigned to the intervention (MOP) or to the control side. Participants will be followed for 3 months and the investigators will take periapical radiographs, cast models and clinical measurements before and after canine retraction. The measurements will be taken by previously calibrated operators. The results are going to be determined and compared between sides, with the corresponding statistical tests and the results are going to be analyzed.
Read the detailed description
PICO QUESTION: ¿Does the amount of distal orthodontic movement of the upper canine increase in the side with MOPs compared with the side without MOPs? Population: Orthodontic patients with bilateral extraction of the upper first premolar (Split mouth design trial) Intervention: Distal movement of the upper canine with Selective MOPs (distal to canine) in one hemi-arch Comparison: Distal movement of the upper canine without MOPs in the other hemi-arch Outcome: Canine and first molar movements
GENERAL AIM:
- To evaluate the effect of selective micro-osteoperforations (MOPs) on the amount of distal movement of the upper canine, the M-D inclination of the canine and the mesial movement of the upper first molar.
METHODS
OVERVIEW OF DESIGN Study Design: Randomized controlled clinical trial in split mouth design.
- Randomly assign upper canines in to 2 sides in a split mouth design study: one side to receive intervention (MOPs) and the other side as a control (without MOPs).
- Then follow both sides for three months
- Split mouth design method: The investigators are going to randomly assign to the patients' left or right sides, one side for the intervention and the other side for the control (to eliminate the possibility of selection bias).
- Blinding: It is not possible to blind participants and clinical staff, but the investigators are going to blind the operators who will perform the measurements and the data analysis (single-blinded).
The participants will be with orthodontic fixed appliances (MBT prescription slot 0.022 "x0.028", canine torque 0 °), with working arches 0.019 "x0.025" stainless steel and with bilateral extractions of the first upper premolars for 6 months or more. For this moment the crowding must be resolved and there must be a space of 3 or more millimeters between the canines and second premolars.
The 4 upper incisors will be consolidated with a 0.010 "stainless steel ligature below the arch to prevent opening of anterior spaces.
Observation:
- No transpalatal arch (TPA) will be used in any of the participants
- It is going to place a mini-implant in the palate for reference point before the start of the experiment PLANS FOR RECRUITMENT Patients of the Clinic University (UniCIEO) and Antioquia University POTENCIAL CONFOUNDING VARIABLES
- Age
- Sex
- Systemic diseases not reported by the participant
- Being tested
- micro-osteoperforations (MOPs)
- Medical subject headings
- Mesial Movement of Teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-osteoperforations (MOPs)Procedure or surgery
three (3) micro-osteoperforations (MOPs) in the cortical and medullar bone, distal to the upper canine. These MOPs will be at the apical, medial and gingival zone of the bone located at the distal surface of the canine in the buccal and in the palatal side. The deep of the MOPs will be at 6 mm. It is going to be done with a PROPEL
| Study group | Role | What they receive |
|---|---|---|
| No micro-osteoperforations (No MOPs) | No intervention | Canine Distalization without micro-osteoperforations Distalization of the upper canine in working phase with coil spring of 100 gr of force |
| Micro-osteoperforations (MOPs) | Experimental | Canine Distalization with micro-osteoperforations at the start of the distalization Distalization of the upper canine in working phase with coil spring of 100 gr of force Receives: Procedure: micro-osteoperforations (MOPs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of distal movement of the upper canine
Distance from a tangent to a reference point in the palate (third palatal ruga) to the distal side of the upper canine (measured in digital models)
Measured: Change from baseline at three months
Inclination of the upper canine, second premolar and first molar
The angle between the long axis of the clinical crown and the reference plane the occlusal plane.(measured in digital models)
Measured: Change from baseline at three months
Angulation of the upper canine, second premolar and first molar
The long axis of the posterior buccal surface is going to be measured relative to the occlusal plane (measured in digital models)
Measured: Change from baseline at three months
Amount of mesial movement of upper first molar
Distance from a tangent to a reference point in the palate (third palatal ruga) to the mesial side of the upper first molar (measured in digital models)
Measured: Change from baseline at three months
Secondary outcomes (4)
Periodontal status
It's going to be measured by clinical exam
Measured: Change from baseline at three months
Evaluation of the perception of pain by the patient: VAS
Pain visual analogue scale (AVS) - from 0 to 10 points, Higher values represent more pain perception by the participant
Measured: Change from baseline at three months
Number of participants with postoperative inflammation and/or infection
Inflammation, infection by clinical exam
Measured: Change from baseline at three months
Number of upper canines with external root resorption
Periapical radiograph
Measured: Change from baseline at three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start2 Dec 2019
- Primary completion9 Mar 2021
- Study completion9 Mar 2021
Why it stopped: The requiered sample were not recruited due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teeth Mesial DriftStudies 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)
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria CIEO
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Antioquia
- Responsible party
- Principal investigator, Sonia Patricia Plaza, Fundación Universitaria CIEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741504
- Sponsor's protocol ID
- 042
- Status last verified
- Mar 2021
- First submitted
- 6 Nov 2018
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data is going to be share only for statistical analysis
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Anchorage With Selective Micro-osteroperforations (MOPs) in Canine Distalization
- ClinicalTrials.gov ID
- NCT03741504
- Acronym / sponsor ID
- 042
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The requiered sample were not recruited due to COVID-19 pandemic
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Fundación Universitaria CIEOUniversity, hospital or other
- Collaborators
- Universidad de Antioquia
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 15 Nov 2018 (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.
To evaluate the effect of selective micro-osteoperforations (MOPs) on the amount of distal movement of the upper canine, the mesio-distal inclination of the canine and the messiah movement of the upper first molar.
Methods: Clinical trial with Split mouth design in 35 orthodontic patients with bilateral extraction of the upper first premolar, each upper canine will be randomly assigned to the intervention (MOP) or to the control side. Participants will be followed for 3 months and the investigators will take periapical radiographs, cast models and clinical measurements before and after canine retraction. The measurements will be taken by previously calibrated operators. The results are going to be determined and compared between sides, with the corresponding statistical tests and the results are going to be analyzed.
Detailed description
PICO QUESTION: ¿Does the amount of distal orthodontic movement of the upper canine increase in the side with MOPs compared with the side without MOPs? Population: Orthodontic patients with bilateral extraction of the upper first premolar (Split mouth design trial) Intervention: Distal movement of the upper canine with Selective MOPs (distal to canine) in one hemi-arch Comparison: Distal movement of the upper canine without MOPs in the other hemi-arch Outcome: Canine and first molar movements
GENERAL AIM:
- To evaluate the effect of selective micro-osteoperforations (MOPs) on the amount of distal movement of the upper canine, the M-D inclination of the canine and the mesial movement of the upper first molar.
METHODS
OVERVIEW OF DESIGN Study Design: Randomized controlled clinical trial in split mouth design.
- Randomly assign upper canines in to 2 sides in a split mouth design study: one side to receive intervention (MOPs) and the other side as a control (without MOPs).
- Then follow both sides for three months
- Split mouth design method: The investigators are going to randomly assign to the patients' left or right sides, one side for the intervention and the other side for the control (to eliminate the possibility of selection bias).
- Blinding: It is not possible to blind participants and clinical staff, but the investigators are going to blind the operators who will perform the measurements and the data analysis (single-blinded).
The participants will be with orthodontic fixed appliances (MBT prescription slot 0.022 "x0.028", canine torque 0 °), with working arches 0.019 "x0.025" stainless steel and with bilateral extractions of the first upper premolars for 6 months or more. For this moment the crowding must be resolved and there must be a space of 3 or more millimeters between the canines and second premolars.
The 4 upper incisors will be consolidated with a 0.010 "stainless steel ligature below the arch to prevent opening of anterior spaces.
Observation:
- No transpalatal arch (TPA) will be used in any of the participants
- It is going to place a mini-implant in the palate for reference point before the start of the experiment PLANS FOR RECRUITMENT Patients of the Clinic University (UniCIEO) and Antioquia University POTENCIAL CONFOUNDING VARIABLES
- Age
- Sex
- Systemic diseases not reported by the participant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No micro-osteoperforations (No MOPs) | No intervention | –Canine Distalization without micro-osteoperforations Distalization of the upper canine in working phase with coil spring of 100 gr of force |
| Micro-osteoperforations (MOPs) | Experimental | Procedure: micro-osteoperforations (MOPs)Canine Distalization with micro-osteoperforations at the start of the distalization Distalization of the upper canine in working phase with coil spring of 100 gr of force |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Class I or Class II malocclusion, division 1 (ANB: 0º-5º) with maxillary canines completely erupted with the need for canine retraction.
- Patients in the working phase with MBT prescription, slot 0.022" who have undergone extractions of bilateral upper premolar with more than three months before the time of upper canine distalization and with open space between the canine and the second premolar greater or equal to 3 mm.
- Age range between 14-40 years.
- Probing depth less than 4 mm in the upper canine
Key exclusion criteria (10 listed)
- Patients with systemic disease.
- Medicated patients (prolonged use of antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, corticosteroids, systemic steroids, and calcium channel blockers).
- Pregnancy.
- Poor oral hygiene evident in more than two visits.
- Overjet ≥ 6 mm
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-osteoperforations (MOPs)three (3) micro-osteoperforations (MOPs) in the cortical and medullar bone, distal to the upper canine. These MOPs will be at the apical, medial and gingival zone of the bone located at the distal surface of the canine in the buccal and in the palatal side. The deep of the MOPs will be at 6 mm. It is going to be done with a PROPEL | Procedure or surgery | Micro-osteoperforations (MOPs) |
Primary outcome
Amount of distal movement of the upper canine
Time frame: Change from baseline at three months
Distance from a tangent to a reference point in the palate (third palatal ruga) to the distal side of the upper canine (measured in digital models)
Inclination of the upper canine, second premolar and first molar
Time frame: Change from baseline at three months
The angle between the long axis of the clinical crown and the reference plane the occlusal plane.(measured in digital models)
Angulation of the upper canine, second premolar and first molar
Time frame: Change from baseline at three months
The long axis of the posterior buccal surface is going to be measured relative to the occlusal plane (measured in digital models)
Amount of mesial movement of upper first molar
Time frame: Change from baseline at three months
Distance from a tangent to a reference point in the palate (third palatal ruga) to the mesial side of the upper first molar (measured in digital models)
4 secondary outcomes
Periodontal status
Time frame: Change from baseline at three months
Evaluation of the perception of pain by the patient: VAS
Time frame: Change from baseline at three months
Number of participants with postoperative inflammation and/or infection
Time frame: Change from baseline at three months
Number of upper canines with external root resorption
Time frame: Change from baseline at three months
Results and safety
The study was stopped early (reason given: The requiered sample were not recruited due to COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Individual participant dataSharing planned: No. Individual participant data is going to be share only for statistical analysis
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micro-osteoperforations (MOPs) in people with Teeth Mesial Drift and Bone Injury, run by Fundación Universitaria CIEO at 2 sites in Colombia.
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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. 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 was stopped early (reason given: The requiered sample were not recruited due to COVID-19 pandemic). Results are not available in the source record.
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?
Amount of distal movement of the upper canine (time frame: Change from baseline at three months). The study lists 4 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 Mar 2021.