NCT03906084

Brief Summary

The aim of the present study was to compare, a standard efficient technique in accelerating OTM as surgical corticotomy as a gold standard versus surgical corticotomy combined with LLLT in an attempt for further acceleration of OTM.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

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

April 1, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

3.1 years

First QC Date

April 3, 2019

Last Update Submit

April 5, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of canine retraction

    Rate of canine retraction using a digital caliper, units of mm, readings extracted from digital models reading each month.

    4 months

Secondary Outcomes (1)

  • Root resorption

    after 4 months from start of clinical trial

Study Arms (2)

Corticotomy facilitated orthodontics.

ACTIVE COMPARATOR

Corticotomy is carried out under local anesthesia in right side.

Procedure: Corticotomy and low laser therapy

Corticotomy and low level laser therapy

EXPERIMENTAL

Corticotomy is carried out under local anesthesia followed by low-intensity laser therapy that is started on the selected experimental side on the same day as placement of the coil spring

Procedure: Corticotomy facilitated Orthodontics

Interventions

Corticotomy is carried out under local anesthesia followed by low-intensity laser therapy that is started on the selected experimental side on the same day as placement of the coil spring

Corticotomy facilitated orthodontics.

Corticotomy is carried out under local anesthesia in right side.

Corticotomy and low level laser therapy

Eligibility Criteria

Age17 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Post pubertal patients with age more than 17 years.
  • Class I or Class II (Angles' classification) malocclusion cases requiring 1st premolar extraction with moderate anchorage.

You may not qualify if:

  • Patients having missing permanent canine teeth in maxillary arch.
  • History of trauma or root canal treatment in maxillary canines.
  • History of previous orthodontic treatment.
  • History of hormonal disorder or syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
Masking Details
Single Blind Endpoint Classification: Efficacy Study
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer, Orthodontics department, Faculty of Dentistry-MSA University

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 8, 2019

Study Start

April 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

April 8, 2019

Record last verified: 2019-04