NCT04383600

Brief Summary

The aim of the present clinical study was directed to evaluate the effectiveness of micro-osteoperforations on the rate of canine retraction; in addition, the potential risk for root resorption during maxillary canine retraction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

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

September 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

1.7 years

First QC Date

May 2, 2020

Last Update Submit

May 7, 2020

Conditions

Keywords

MOPsmicro-osteoperforationaccelerationorthodontic tooth movement

Outcome Measures

Primary Outcomes (2)

  • Rate of canine retraction

    Clinically, patients were evaluated immediately before canine retraction and every 4 weeks till complete space closure (complete canine retraction). 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 complete space closure up to 6 months

  • Canine root length changes

    The CBCT scans were taken before orthodontic treatment and after complete space closure (canine retraction) to be analyzed for assessment of Canine root length changes. The root length was measured along the axis of the root, perpendicular to a line connecting the buccal and palatal cemento-enamel junction CEJ in sagittal view

    change from start of orthodontic treatment until complete space closure up to 9 months

Secondary Outcomes (1)

  • Anchorage loss of maxillary first permanent molars.

    change from start of orthodontic treatment until complete space closure up to 9 months

Study Arms (2)

Conventional side

NO INTERVENTION

Canine retraction was commenced without micro-osteoperforations.

Mops side

EXPERIMENTAL

Canine retraction was commenced with micro-osteoperforations.

Procedure: Micro-osteoperforation

Interventions

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

Also known as: Mops
Mops side

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • An age ranged between 14 to 18 years.
  • Class II division 1 malocclusion or Class I bimaxillary protrusion with mild or no crowding. Wherever crowding was present, it was symmetrical on both sides of the arch.
  • Patients who diagnosed to require extraction of at least maxillary first premolars bilaterally as a part of their treatment plan.
  • Complete permanent dentition (3rdmolars were not included).
  • Good oral and general health.
  • No history of periodontal problems.
  • No therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances during the study period.

You may not qualify if:

  • Blocked out or impacted maxillary canines.
  • Transverse and/or vertical skeletal dysplasia or craniofacial anomalies.
  • Systemic diseases or regular use of medications that could interfere with orthodontic treatment.
  • 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 Officials

  • Ahmed El Awady

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2020

First Posted

May 12, 2020

Study Start

September 1, 2017

Primary Completion

May 15, 2019

Study Completion

June 5, 2019

Last Updated

May 12, 2020

Record last verified: 2020-05

Locations