Effect of Implant Driver Facilitated Micro-osteo Perforation on the Rate of Tooth Movement.

April 15, 2022 updated by: DR MARIA HABIB, Bahria University

Effect of Implant Driver Facilitated Micro-osteo Perforations on the Rate of Tooth Movement.

we have conducted a split-mouth randomized clinical trial to study effects of implant induced micro-osteoperforations on the rate of tooth movement during canine retraction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The experimental group will receive implant driver facilitated microosteoperforation on one side of the mouth( according to split mouth design) decided by random allocation.

After 3 months of extraction of upper first premolar ( according to planned orthodontic treatment), 3 microosteoperforation will be done with implant in an implant driver distal to canine. Surgical procedure will be done in local anesthesia, no flap will be raised. Alginate impressions will be taken before the procedure and 28 days after canine retraction has started, to measure the difference between rate of canine retraction on both sides. Measurement was done by a digital vernier caliper,

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75200
        • Bahria University Medical and Dental College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Male and female

    • Age 18- 45 years
    • Class 2 div 1
    • No systemic disease
    • No radiographic evidence of bone loss
    • No history of periodontal therapy
    • No current active periodontal disease
    • No smoking
    • No gingivitis or untreated caries
    • Probing depth < 4mm in all teeth
    • Gingival index < 1mm
    • Plaque index < 1mm

Exclusion Criteria:

  • Long term use of antibiotics, phenytoin,cyclosporine, anti inflammatory drugs, systemic corticosteroids and calcium channel blockers.
  • Poor oral hygiene for more than 2 visits.
  • Extreme skeletal class 2 malocclusion, overjet > 10mm, anb> 7
  • Systemic disease
  • Evidence of bone loss
  • Past periodontal disease
  • Current periodontal disease
  • Smoking
  • Gingivitis and caries
  • Probing depth > 4mm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mop group
a group of patients with a class 2 divsion 1 dental malocclusion, overjet greater than 9 mm, extraction of upper first premolars planned, and it has been 3 months post extraction and before canine retraction is commenced.
Procedure: implant driver facilitated micro-osteoperforations

3 micro-osteoperforations(in a vertical pattern) are done on the randomly allocated experimental side , distal to canine under local anesthesia. the other side of the mouth is used as a control.

alginate impression is taken before the intervention .

Other Names:
  • micro-osteoperforations by any other means.
Active Comparator: mop group ( same)
a group of patients with a class 2 divsion 1 dental malocclusion, overjet greater than 9 mm, extraction of upper first premolars planned, and it has been 3 months post extraction and before canine retraction is commenced.
Procedure: implant driver facilitated micro-osteoperforations

3 micro-osteoperforations(in a vertical pattern) are done on the randomly allocated experimental side , distal to canine under local anesthesia. the other side of the mouth is used as a control.

alginate impression is taken before the intervention .

Other Names:
  • micro-osteoperforations by any other means.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing rate of canine retraction between intervention and non-intervention side.
Time Frame: 28 days
distance from cusp tip of canine to mesio-buccal cusp tip of molar taken by digital vernier caliper.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2018

Primary Completion (Actual)

January 15, 2022

Study Completion (Actual)

March 20, 2022

Study Registration Dates

First Submitted

April 15, 2022

First Submitted That Met QC Criteria

April 15, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 15, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ERC 05/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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