NCT05339620

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

4 years

First QC Date

April 15, 2022

Last Update Submit

April 15, 2022

Conditions

Tooth Movement Techniques

Keywords

micro-osteoperforations, tooth movement, implant driver

Outcome Measures

Primary Outcomes (1)

  • Comparing rate of canine retraction between intervention and non-intervention side.

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

    28 days

Study Arms (2)

mop group

EXPERIMENTAL

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

mop group ( same)

ACTIVE COMPARATOR

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

Interventions

implant driver facilitated micro-osteoperforationsPROCEDURE

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 .

Also known as: micro-osteoperforations by any other means.
mop groupmop group ( same)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahria University Medical and Dental College

Karachi, Sindh, 75200, Pakistan

Location

Related Publications (4)

  • Cheung T, Park J, Lee D, Kim C, Olson J, Javadi S, Lawson G, McCabe J, Moon W, Ting K, Hong C. Ability of mini-implant-facilitated micro-osteoperforations to accelerate tooth movement in rats. Am J Orthod Dentofacial Orthop. 2016 Dec;150(6):958-967. doi: 10.1016/j.ajodo.2016.04.030.

    PMID: 27894545BACKGROUND

  • Ozkan TH, Arici S. The effect of different micro-osteoperforation depths on the rate of orthodontic tooth movement: A single-center, single-blind, randomized clinical trial. Korean J Orthod. 2021 May 25;51(3):157-165. doi: 10.4041/kjod.2021.51.3.157.

    PMID: 33984223BACKGROUND

  • Aboalnaga AA, Salah Fayed MM, El-Ashmawi NA, Soliman SA. Effect of micro-osteoperforation on the rate of canine retraction: a split-mouth randomized controlled trial. Prog Orthod. 2019 Jun 3;20(1):21. doi: 10.1186/s40510-019-0274-0.

    PMID: 31155698BACKGROUND

  • Bolat Gumus E, Kinsiz E. Effects of miniscrew-facilitated micro-osteoperforations on the rate of orthodontic tooth movement : A split-mouth, randomized controlled trial. J Orofac Orthop. 2023 Apr;84(Suppl 2):104-110. doi: 10.1007/s00056-021-00371-6. Epub 2022 Jan 13.

    PMID: 35024875BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 15, 2022

First Posted

April 21, 2022

Study Start

January 7, 2018

Primary Completion

January 15, 2022

Study Completion

March 20, 2022

Last Updated

April 21, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)