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

Foundation University Islamabad

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Rate of Canine Retraction

Pain

Treatments

Other: micro osteoperforation

Study type

Interventional

Funder types

Other

Identifiers

NCT06432699

FF/FUMC/215-372Phy/23

Details and patient eligibility

About

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

Full 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

Enrollment

60 estimated patients

Sex

All

Ages

14 to 40 years old

Volunteers

Accepts Healthy Volunteers

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..

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

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