NCT04968327

Brief Summary

the study aimed to clinically evaluate the effect of micro-osteoperforations on the rate of tooth movement, as evaluated by its effect on the rate of canine retraction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2017

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

8 months

First QC Date

July 5, 2021

Last Update Submit

July 8, 2021

Conditions

Malocclusion

Outcome Measures

Primary Outcomes (1)

  • Rate of canine retraction

    measurements were recorded from digital dental models every 3 weeks

    12 weeks

Secondary Outcomes (1)

  • Measurment of canine tipping

    12 weeks

Study Arms (2)

Micro-osteoperforations

EXPERIMENTAL
Other: Micro-osteoperforations (MOPs)Other: Conventional canine retraction

Canine retraction

ACTIVE COMPARATOR
Other: Conventional canine retraction

Interventions

Micro-osteoperforations (MOPs)OTHER

MOPs included shallow perforations of the buccal cortical plate surrounding the tooth that requires orthodontic tooth movement, with no flap reflection was performed using a surgical bur using the special calibrated device called PROPEL

Micro-osteoperforations
Conventional canine retractionOTHER

using nickel-titanium (NiTi) closed coil-springs delivering a force of 150 grams per side

Canine retractionMicro-osteoperforations

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • healthy systemic condition with no chronic diseases
  • no previous orthodontic treatment
  • adequate oral hygiene
  • have a healthy periodontium
  • signed an informed consent

You may not qualify if:

  • have a chronic disease
  • previous orthodontic treatment
  • poor oral hygiene or periodontal conidition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: split-mouth
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer of DPH and Clinical statistician

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 20, 2021

Study Start

January 1, 2017

Primary Completion

August 18, 2017

Study Completion

August 30, 2017

Last Updated

July 20, 2021

Record last verified: 2021-07

Locations

EG(1)