Rate of Canine Retraction and Pain Perception Following Micro-osteoperforation- a Split Mouth Clinical Study

Pain Clinical Trial

— MOPS  

Official title:

Rate of Canine Retraction and Pain Perception Following Micro-osteoperforation- a Split

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06432699
• Other study ID #: FF/FUMC/215-372Phy/23
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Foundation University Islamabad
• Contact: Rozina Nazir, FCPS
• Phone: +92 3215376612
• Email: rozina.nazir[@]fui.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

1. Presence of any craniofacial abnormality.

2. Any history of bleeding disorders.

3. Poor oral hygiene.

4. Use of bisphosphonates, analgesics, anti-inflammatory drugs, corticosteroids for more than three months prior to treatment or during treatment.

5. Active diseases such as metabolic bone disease.

6. Malocclusions requiring surgical intervention.

7. Smoker

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Related Conditions & MeSH terms

• Pain

Intervention

Other:
• micro osteoperforation
one side used for mops while other side will be control in same patient

Locations

Country	Name	City	State
Pakistan	Foundation University Islamabad	Islamabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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 Gümüs, E., Kinsiz, 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	three months since the MOPS