Clinical trial NCT05995509: The Effect of Number of Micro-osteo-perforations on the Rate of Tooth Movement.
Official title: The Effect of Number of Micro-osteo-perforations on the Rate of Tooth Movement: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthodontic Tooth Movement
Keywords: Micro-osteo-perforations
orthodontic tooth movement
clinical trial
Lead sponsor: Rehman Medical Institute - RMI
Sponsor class: OTHER
Collaborators: name: Gandhara University
First posted: 2023-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria: All male and female patients in an age range of 12-25 years requiring bilateral first premolar extraction in maxillary arch.

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Exclusion Criteria:

1. Patients with any sort of systemic disease.
2. Radiographic evidence of bone loss.
3. History of periodontal therapy
4. Active periodontal disease.
5. Patients with a history of smoking of five years or more.
6. Patients with active gingivitis and Caries.
7. Attrition of canine cusp.

Primary outcomes:
measure: The rate of tooth movement (canine retraction)
timeFrame: 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:
measure: Pain associated with MOPs
timeFrame: In the surgery after the procedure is completed and just before the patient was sent home.
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: RMI
Study officials:
affiliation: Sardar Begum Dental College
name: Imran Tajik, FCPS
role: STUDY_CHAIR
References: