The Effect of Number of Micro-osteo-perforations on the Rate of Tooth Movement.

NCT ID: NCT05995509

Last Updated: 2023-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-21

Study Completion Date

2024-06-01

Brief Summary

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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

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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.

Conditions

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Orthodontic Tooth Movement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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3 MOPs group

The subjects under a split mouth intervention on the experimental side will undergo 3 micro-osteo-perforations (creating small holes in the buccal cortical bone) to assess the rate of tooth movement.

Group Type ACTIVE_COMPARATOR

Micro-osteo-perforations

Intervention Type PROCEDURE

small perforations drilled in Alveolar bone, adjacent to site of tooth movement.

1 MOP group

the subjects under the split mouth intervention on the control side will undergo 1 micro-osteo-perforation in comparison to the experimental side.

Group Type EXPERIMENTAL

Micro-osteo-perforations

Intervention Type PROCEDURE

small perforations drilled in Alveolar bone, adjacent to site of tooth movement.

Interventions

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Micro-osteo-perforations

small perforations drilled in Alveolar bone, adjacent to site of tooth movement.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\-

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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gandhara University

OTHER

Sponsor Role collaborator

Rehman Medical Institute - RMI

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Imran Tajik, FCPS

Role: STUDY_CHAIR

Sardar Begum Dental College

Locations

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RMI

Peshawar, , Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Javaid

Role: CONTACT

03349590787

Sohrab Shaheed, FFDRCSI

Role: CONTACT

03339327608

Facility Contacts

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RMI

Role: primary

03349590787

RMI

Role: backup

Other Identifiers

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CPSP/REU/DSG-2017-026-2176

Identifier Type: -

Identifier Source: org_study_id

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