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

NCT ID: NCT06432699

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-12-30

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

Participants in this arm will receive no MOP treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental

participants in this arm will receive MOPS intervention

Group Type: EXPERIMENTAL

micro osteoperforation

Intervention Type: OTHER

one side used for mops while other side will be control in same patient

Interventions

micro osteoperforation

one side used for mops while other side will be control in same patient

Intervention Type: OTHER

Other Intervention Names

Placebo/Controlled

Eligibility Criteria

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

-

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Foundation University Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Shoaib Rahim

ZAINAB BUTT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Foundation University Islamabad

Islamabad, Punjab Province, Pakistan

Countries

Pakistan

References

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

Reference Type: BACKGROUND

Other Identifiers

FF/FUMC/215-372Phy/23

Identifier Type: -

Identifier Source: org_study_id