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

Sponsor
Bahria University (Other)
Overall Status
Completed
CT.gov ID
NCT05339620
Collaborator
(none)
22
Enrollment
1
Location
2
Arms
50.4
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: implant driver facilitated micro-osteoperforations
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
double blind
Primary Purpose:
Treatment
Official Title:
Effect of Implant Driver Facilitated Micro-osteo Perforations on the Rate of Tooth Movement.
Actual Study Start Date :
Jan 7, 2018
Actual Primary Completion Date :
Jan 15, 2022
Actual Study Completion Date :
Mar 20, 2022

Arms and Interventions

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.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Comparing rate of canine retraction between intervention and non-intervention side. [28 days]

      distance from cusp tip of canine to mesio-buccal cusp tip of molar taken by digital vernier caliper.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bahria University Medical and Dental College Karachi Sindh Pakistan 75200

    Sponsors and Collaborators

    • Bahria University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    DR MARIA HABIB, Assistant Professor, Bahria University
    ClinicalTrials.gov Identifier:
    NCT05339620
    Other Study ID Numbers:
    • ERC 05/2018
    First Posted:
    Apr 21, 2022
    Last Update Posted:
    Apr 21, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by DR MARIA HABIB, Assistant Professor, Bahria University
    micro-osteoperforations, tooth movement, implant driver

    Study Results

    No Results Posted as of Apr 21, 2022