NCT04868721

Brief Summary

The aim of this clinical prospective study will be directed to evaluate two approaches of micro-osteoperforations (MOPs) during orthodontic canine retraction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

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

November 11, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2022

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

1.3 years

First QC Date

April 25, 2021

Last Update Submit

June 14, 2022

Conditions

Keywords

Micro-osteoperforationAccelerated orthodonticsTooth movementCanine retraction

Outcome Measures

Primary Outcomes (1)

  • Rate of canine retraction

    clinically, patients were evaluated immediately before canine retraction and every 28days until for months. It was based on measuring the distance between the contact points on the distal surface of the canines and the contact points on mesial surface of the second premolars.

    change from start of canine retraction until 4 months .

Study Arms (3)

control side

NO INTERVENTION

Conventional side Canine retraction was commenced without micro-osteoperforations.

single Micro-osteoperforations side

EXPERIMENTAL

Three flapless micro-osteoperforations (MOPs) was performed for one time only distal to the maxillary canine before starting retraction.

Procedure: micro-osteoperforations

Multiple Micro-osteoperforations side

EXPERIMENTAL

Three flapless micro-osteoperforations (MOPs) was performed on repeated basis distal to the maxillary canine evey 28 days before canine retraction.

Procedure: micro-osteoperforations

Interventions

three flapless micro-osteoperforations was performed distal to the maxillary canine before starting retraction.

Also known as: MOPs
Multiple Micro-osteoperforations sidesingle Micro-osteoperforations side

Eligibility Criteria

Age15 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age range from 15-22 years.
  • Malocclusion cases that require maxillary first premolars extractions followed by symmetrical canine retraction.
  • All permanent teeth present, 3rd molars are excluded.
  • Good oral and general health.
  • No systemic disease/medication that could interfere with OTM.
  • No previous orthodontic treatment.

You may not qualify if:

  • Patient diagnosed to have an indication for non-extraction approach.
  • Poor oral hygiene or periodontally compromised patient.
  • Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
  • Previous orthodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al azhar university

Cairo, Egypt

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

morpholinopropane sulfonic acid

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist, Ministry of Health-Egypt

Study Record Dates

First Submitted

April 25, 2021

First Posted

May 3, 2021

Study Start

November 11, 2020

Primary Completion

February 14, 2022

Study Completion

June 14, 2022

Last Updated

June 16, 2022

Record last verified: 2022-06

Locations