PainMOPSNCT06432699
Rate of Canine Retraction and Pain Perception Following Micro-osteoperforation- a Split Mouth Clinical Study
A study testing micro osteoperforation in people with Pain and Rate of Canine Retraction, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
DEFINITION: A short description of clinical study , including a brief statement of clinical study's hypothesis, written in language intended for the lay public Limit: 5000 CHARACTERS Read more about this study
- Who is it for?
- Ages 14 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Rate of Canine Retraction
- What is being tested?
- micro osteoperforation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2024to 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 14 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1. Age range around 15-40 years. 2. Patients which have class I malocclusion or class II Div I malocclusion and include first premolar extraction as part of treatment plan..
- 3. No orthodontic treatment previously 4. Radiographic evidence showing no bone loss 5. History showing no periodontal disease. 6. History showing no systemic disease. 7. Probing depth less than 4 mm across the entire dentition 8. No active carious lesion or any sign of gingivitus
Who cannot join
- Presence of any craniofacial abnormality.
- Any history of bleeding disorders.
- Poor oral hygiene.
- Use of bisphosphonates, analgesics, anti-inflammatory drugs, corticosteroids for more than three months prior to treatment or during treatment.
- Active diseases such as metabolic bone disease.
- Malocclusions requiring surgical intervention.
- Smoker
- -
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University Islamabad
Islamabad, Punjab Province, 04403
About this study
Official title: Rate of Canine Retraction and Pain Perception Following Micro-osteoperforation- a Split
DEFINITION: A short description of clinical study , including a brief statement of clinical study's hypothesis, written in language intended for the lay public Limit: 5000 CHARACTERS
Read the detailed description
Definition: Extended description of the protocol ,including more technical information(as compared to the brief Summary), if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures.
Limit:32,000 characters. For Patient Registries: Also describe the applicable registry procedures and other quality factors (for examples, third party certification, on site audit). In particular , summarize any procedures implemented as part of the patient registry, including , but not limited to the following:
- Quality assurance plan that addresses data validation and registry procedures, including and plans for site monitoring and auditing
- Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
- Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources( for example, medical records, paper or electronic case reports forms, or interactive voice response systems)
- Data Dictionary that contains detailed descriptions of each variable used by the registry, including, including the source of the variable, coding information if used (for example World Health Organization Drug Dictionary, MedDRA), and normal ranges if relevant.
- STANDARD OPERATING PROCEDURE TO ADDRESS REGISTRY REGISTRY OPERATIONS AND ANALYSISACTIVITIES, SUCH AS PATIENT RECRUITMENT DATA COLLECTION,DATA MANAGEMENT., DATA ANALYSIS, reporting for adverse events, and change management.
- Sample Size Assessment to specify the number of participants or participate years necessary to demonstrate an effect.
- Plan for missing data to address situations where variable are reported a missing , unavailable non-reported, interpretable, or considered missing because of data inconsistency or out-of-range results.
- Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives , as specified in the study protocol or plan
- Conditions
- Pain, Rate of Canine Retraction
- Being tested
- micro osteoperforation
- Keywords
- MOP
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro osteoperforationOther
Also called Placebo/Controlled
one side used for mops while other side will be control in same patient
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in this arm will receive no MOP treatment |
| Experimental | Experimental | participants in this arm will receive MOPS intervention Receives: Other: micro osteoperforation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain will be measured after intervention of visual analogue scale
patient after undergoing micro-osteoperforation will be aske to measure pain and check rate of canine retraction
Measured: three months since the MOPS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start1 May 2024
- Primary completion30 Jul 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-blind, randomized parallel-arm study with two arms. Participants will be randomly assigned to either MOPS or no Mops
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shoaib Rahim, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432699
- Sponsor's protocol ID
- FF/FUMC/215-372Phy/23
- Acronym
- MOPS
- Status last verified
- Jun 2024
- First submitted
- 23 May 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1. Kundi, I., Alam, M. K., & Shaheed, S. (2020). Micro-osteo perforation effects as an intervention on canine retraction. The Saudi dental journal, 32(1), 15-20. https://doi.org/10.1016/j.sdentj.2019.05.009 2. Husain S, Sundari S. Comparison of the effectiveness of piezocision-aided canine retraction augmented with micro-osteoperforation: a randomized controlled trial. Angle Orthod. 2023 Oct 16. doi: 10.2319/052323-370.1. Epub ahead of print. PMID: 37839802. 12 3. Aboalnaga AA, Aboalnaga AA, Salah Fayed MM, El-Ashmawi NA, Soliman SA. Effect of micro-osteoperforation on the rate of canine retraction: a split- mouth randomized controlled trial. Prog Orthod. 2019 Jun;20(1) 21. doi:10.1186/s40510-019-0274-0. PMID: 31155698; PMCID: PMC6545296. 4. Bolat Gümüş, E., Kınsız, E. Effects of miniscrew-facilitated micro- osteoperforations on the rate of orthodontic tooth movement. J Orofac Orthop 84 (Suppl 2), 104-110 (2023). 5. Martina K., Kumar P., Misra V., Attri S., Yadav A., Sam R., Kumar R.. To evaluate the rate of canine retraction and pain perception following micro- osteoperforation - a split-mouth clinical study. Australasian Orthodontic Journal. 2022;38(2): 388-395
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Canine Retraction and Pain Perception Following Micro-osteoperforation- a Split
- ClinicalTrials.gov ID
- NCT06432699
- Acronym / sponsor ID
- MOPS / FF/FUMC/215-372Phy/23
- Conditions
- Pain, Rate of Canine Retraction
- Keywords
- MOP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 29 May 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.
DEFINITION: A short description of clinical study , including a brief statement of clinical study's hypothesis, written in language intended for the lay public Limit: 5000 CHARACTERS
Detailed description
Definition: Extended description of the protocol ,including more technical information(as compared to the brief Summary), if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures.
Limit:32,000 characters. For Patient Registries: Also describe the applicable registry procedures and other quality factors (for examples, third party certification, on site audit). In particular , summarize any procedures implemented as part of the patient registry, including , but not limited to the following:
- Quality assurance plan that addresses data validation and registry procedures, including and plans for site monitoring and auditing
- Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
- Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources( for example, medical records, paper or electronic case reports forms, or interactive voice response systems)
- Data Dictionary that contains detailed descriptions of each variable used by the registry, including, including the source of the variable, coding information if used (for example World Health Organization Drug Dictionary, MedDRA), and normal ranges if relevant.
- STANDARD OPERATING PROCEDURE TO ADDRESS REGISTRY REGISTRY OPERATIONS AND ANALYSISACTIVITIES, SUCH AS PATIENT RECRUITMENT DATA COLLECTION,DATA MANAGEMENT., DATA ANALYSIS, reporting for adverse events, and change management.
- Sample Size Assessment to specify the number of participants or participate years necessary to demonstrate an effect.
- Plan for missing data to address situations where variable are reported a missing , unavailable non-reported, interpretable, or considered missing because of data inconsistency or out-of-range results.
- Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives , as specified in the study protocol or plan
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-blind, randomized parallel-arm study with two arms. Participants will be randomly assigned to either MOPS or no Mops
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in this arm will receive no MOP treatment |
| Experimental | Experimental | Other: micro osteoperforationparticipants in this arm will receive MOPS intervention |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 1. Age range around 15-40 years. 2. Patients which have class I malocclusion or class II Div I malocclusion and include first premolar extraction as part of treatment plan..
- 3. No orthodontic treatment previously 4. Radiographic evidence showing no bone loss 5. History showing no periodontal disease. 6. History showing no systemic disease. 7. Probing depth less than 4 mm across the entire dentition 8. No active carious lesion or any sign of gingivitus
Key exclusion criteria (8 listed)
- Presence of any craniofacial abnormality.
- Any history of bleeding disorders.
- Poor oral hygiene.
- Use of bisphosphonates, analgesics, anti-inflammatory drugs, corticosteroids for more than three months prior to treatment or during treatment.
- Active diseases such as metabolic bone disease.
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: Placebo/Controlledone side used for mops while other side will be control in same patient | Other | Experimental |
Primary outcome
pain will be measured after intervention of visual analogue scale
Time frame: three months since the MOPS
patient after undergoing micro-osteoperforation will be aske to measure pain and check rate of canine retraction
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 27 Jan 2025.
- Background1. Kundi, I., Alam, M. K., & Shaheed, S. (2020). Micro-osteo perforation effects as an intervention on canine retraction. The Saudi dental journal, 32(1), 15-20. https://doi.org/10.1016/j.sdentj.2019.05.009 2. Husain S, Sundari S. Comparison of the effectiveness of piezocision-aided canine retraction augmented with micro-osteoperforation: a randomized controlled trial. Angle Orthod. 2023 Oct 16. doi: 10.2319/052323-370.1. Epub ahead of print. PMID: 37839802. 12 3. Aboalnaga AA, Aboalnaga AA, Salah Fayed MM, El-Ashmawi NA, Soliman SA. Effect of micro-osteoperforation on the rate of canine retraction: a split- mouth randomized controlled trial. Prog Orthod. 2019 Jun;20(1) 21. doi:10.1186/s40510-019-0274-0. PMID: 31155698; PMCID: PMC6545296. 4. Bolat Gümüş, E., Kınsız, E. Effects of miniscrew-facilitated micro- osteoperforations on the rate of orthodontic tooth movement. J Orofac Orthop 84 (Suppl 2), 104-110 (2023). 5. Martina K., Kumar P., Misra V., Attri S., Yadav A., Sam R., Kumar R.. To evaluate the rate of canine retraction and pain perception following micro- osteoperforation - a split-mouth clinical study. Australasian Orthodontic Journal. 2022;38(2): 388-395
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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 osteoperforation in people with Pain and Rate of Canine Retraction, run by Foundation University Islamabad 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 2 inclusion and 8 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 27 Jan 2025. 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?
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?
pain will be measured after intervention of visual analogue scale (time frame: three months since the MOPS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06432699, which also lists 1 linked publication.
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 27 Jan 2025.