Orthodontic Tooth MovementMOPsNCT05995509
The Effect of Number of Micro-osteo-perforations on the Rate of Tooth Movement.
A study testing Micro-osteo-perforations in people with Orthodontic Tooth Movement, run by Rehman Medical Institute - RMI at 1 site in Pakistan.
Trial summary
The objective of this split mouth trial is to compare mean canine retraction with one Micro-osteo-perforation (MOP) against three MOPs among Class II division I orthodontic patients after one month of intervention. Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Tooth Movement
- What is being tested?
- Micro-osteo-perforations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Mar 2023to 1 Jun 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 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Patients with any sort of systemic disease.
- Radiographic evidence of bone loss.
- History of periodontal therapy
- Active periodontal disease.
- Patients with a history of smoking of five years or more.
- Patients with active gingivitis and Caries.
- Attrition of canine cusp.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
RMI
Peshawar
RMI, 03349590787, asmjavaid@gmail.com
RMI
About this study
Official title: The Effect of Number of Micro-osteo-perforations on the Rate of Tooth Movement: A Randomized Controlled Trial.
The objective of this split mouth trial is to compare mean canine retraction with one Micro-osteo-perforation (MOP) against three MOPs among Class II division I orthodontic patients after one month of intervention.
Read the detailed description
One of the main concerns for orthodontists and patients who seek orthodontic therapy is the prolonged treatment time. A commitment of about 18-24 months makes decision making difficult for many patients. The prolonged treatment time is also a potential factor leading to complications like white spot lesions, root resorption, gingivitis and periodontitis. Different techniques to speed up tooth movement have been used in orthodontics. Micro-osteo-perforations is one of the new ways to expedite tooth movement. Previous trials of MOP (Micro-osteo-perforations) to expedite tooth movement had certain shortcomings including the lack of details of randomization. Further studies with variation in the number and frequency of MOPs over a longer duration were recommended. It also raises a curiosity if reducing the number of MOPs would be equally effective in accelerating the canine retraction. Hence, the purpose of this split mouth trial was to investigate the effect of number of MOPs on the rate of canine retraction.
The objective of this split mouth trial is to compare mean canine retraction with one MOP against three MOPs among Class II division I orthodontic patients after one month of intervention.
STUDY DESIGN: Split-mouth parallel arm randomized control trial.
- Conditions
- Orthodontic Tooth Movement
- Being tested
- Micro-osteo-perforations
- Keywords
- Micro-osteo-perforations, orthodontic tooth movement, clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-osteo-perforationsProcedure or surgery
small perforations drilled in Alveolar bone, adjacent to site of tooth movement.
| Study group | Role | What they receive |
|---|---|---|
| 3 MOPs group | Active comparator | The subjects under a split mouth intervention on the experimental side will undergo 3 micro-osteo-perforations (creating small holes in the buccal cortical bone) to assess the rate of tooth movement. Receives: Procedure: Micro-osteo-perforations |
| 1 MOP group | Experimental | the subjects under the split mouth intervention on the control side will undergo 1 micro-osteo-perforation in comparison to the experimental side. Receives: Procedure: Micro-osteo-perforations |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of tooth movement (canine retraction)
The canine retraction will be measured from a mid-palatine line drawn on the pre treatment and post MOP dental cast. Further perpendicular lines will be drawn towards the distal surface of canine and the mesial surface of the second premolar. The Canine retraction will be measured as the difference between the two lines measured in millimetres. The clinical significance will be set at 50% or more of the rate of canine retraction of the control side.
Measured: The movement of canines on both sides will be measured after 30 days of 150g of force application on the intervention and control side.
Secondary outcomes (1)
Pain associated with MOPs
The pain or discomfort to the patient will be assessed using a Baker's visual analogue scale on the control and the experimental sides. The scale will be calibrated in millimetres from 0-10 with 0 denoting no pain and 10 denoting worst pain possible.
Measured: In the surgery after the procedure is completed and just before the patient was sent home.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start21 Mar 2023
- Primary completion31 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Tooth MovementStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rehman Medical Institute - RMI
- Sponsor type
- University, hospital or other
- Collaborators
- Gandhara University
- Responsible party
- Sponsor
- Investigators
- Imran Tajik, FCPS, Study chair, Sardar Begum Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995509
- Sponsor's protocol ID
- CPSP/REU/DSG-2017-026-2176
- Acronym
- MOPs
- Status last verified
- Aug 2023
- First submitted
- 13 May 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Number of Micro-osteo-perforations on the Rate of Tooth Movement: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05995509
- Acronym / sponsor ID
- MOPs / CPSP/REU/DSG-2017-026-2176
- Conditions
- Orthodontic Tooth Movement
- Keywords
- Micro-osteo-perforations, orthodontic tooth movement, clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rehman Medical Institute - RMIUniversity, hospital or other
- Collaborators
- Gandhara University
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 16 Aug 2023 (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 objective of this split mouth trial is to compare mean canine retraction with one Micro-osteo-perforation (MOP) against three MOPs among Class II division I orthodontic patients after one month of intervention.
Detailed description
One of the main concerns for orthodontists and patients who seek orthodontic therapy is the prolonged treatment time. A commitment of about 18-24 months makes decision making difficult for many patients. The prolonged treatment time is also a potential factor leading to complications like white spot lesions, root resorption, gingivitis and periodontitis. Different techniques to speed up tooth movement have been used in orthodontics. Micro-osteo-perforations is one of the new ways to expedite tooth movement. Previous trials of MOP (Micro-osteo-perforations) to expedite tooth movement had certain shortcomings including the lack of details of randomization. Further studies with variation in the number and frequency of MOPs over a longer duration were recommended. It also raises a curiosity if reducing the number of MOPs would be equally effective in accelerating the canine retraction. Hence, the purpose of this split mouth trial was to investigate the effect of number of MOPs on the rate of canine retraction.
The objective of this split mouth trial is to compare mean canine retraction with one MOP against three MOPs among Class II division I orthodontic patients after one month of intervention.
STUDY DESIGN: Split-mouth parallel arm randomized control trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 MOPs group | Active comparator | Procedure: Micro-osteo-perforationsThe subjects under a split mouth intervention on the experimental side will undergo 3 micro-osteo-perforations (creating small holes in the buccal cortical bone) to assess the rate of tooth movement. |
| 1 MOP group | Experimental | Procedure: Micro-osteo-perforationsthe subjects under the split mouth intervention on the control side will undergo 1 micro-osteo-perforation in comparison to the experimental side. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Patients with any sort of systemic disease.
- Radiographic evidence of bone loss.
- History of periodontal therapy
- Active periodontal disease.
- Patients with a history of smoking of five years or more.
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-perforationssmall perforations drilled in Alveolar bone, adjacent to site of tooth movement. | Procedure or surgery | 1 MOP group, 3 MOPs group |
Primary outcome
The rate of tooth movement (canine retraction)
Time frame: The movement of canines on both sides will be measured after 30 days of 150g of force application on the intervention and control side.
The canine retraction will be measured from a mid-palatine line drawn on the pre treatment and post MOP dental cast. Further perpendicular lines will be drawn towards the distal surface of canine and the mesial surface of the second premolar. The Canine retraction will be measured as the difference between the two lines measured in millimetres. The clinical significance will be set at 50% or more of the rate of canine retraction of the control side.
1 secondary outcome
Pain associated with MOPs
Time frame: In the surgery after the procedure is completed and just before the patient was sent home.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Imran Tajik, FCPS study chair
Sardar Begum Dental College
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-perforations in people with Orthodontic Tooth Movement, run by Rehman Medical Institute - RMI at 1 site in Pakistan.
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 7 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 16 Aug 2023. 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 Pakistan. 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 Javaid (03349590787, asmjavaid@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of tooth movement (canine retraction) (time frame: The movement of canines on both sides will be measured after 30 days of 150g of force application on the intervention and control side.). 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 Aug 2023.