NCT04381442

Brief Summary

The aim of this study was to determine whether orthodontically moved maxillary canines exposed to two different protocols and dosage of LLLT exhibited differences in amount and rate of orthodontic tooth movement.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

1.7 years

First QC Date

May 6, 2020

Last Update Submit

May 6, 2020

Conditions

Keywords

Low Level Laser TherapyOrthodontic Tooth movementCanine RetractionTwo Protocols and Energy Doses

Outcome Measures

Primary Outcomes (1)

  • Evaluation the rate of maxillary canine retraction

    Evaluation and comparison of amount and monthly rate of distal movement of maxillary canine, in both groups, that were determined by direct intraoral measurements and indirect measurements of 3D scanned study models

    6 Months

Secondary Outcomes (1)

  • Evaluation of anchorage loss

    6 Months

Study Arms (2)

Buccal &palatal low level laser therapy

EXPERIMENTAL

In group I,low level laser therapy was delivered at 10 points; 5 from buccal and 5 from palatal aspects with a total dose of 8 Joule (J) per session that distributed as follows; 2 cervical, 1 middle, 2 apical. Maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous mode with 635 nm, 100 mW, 25 J/cm2, 8 seconds/ point, 0.8 J/point.Maxillary canines were distalized by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil spring.Laser regimen was applied on days 0, 3, 7, and 14 in the 1st month, and thereafter on every 15th day until 6-month observation period of canine retraction phase.

Radiation: Low Level Laser Therapy

Buccal low level laser therapy

ACTIVE COMPARATOR

In group II, low level laser therapy was delivered at 5 points; from buccal palatal aspects only with a total dose of 4 Joule (J) per session that distributed as follows; 2 cervical, 1 middle, 2 apical. Maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous mode with 635 nm, 100 mW, 25 J/cm2, 8 seconds/ point, 0.8 J/point.Maxillary canines were distalized by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil spring.Laser regimen was applied on days 0, 3, 7, and 14 in the 1st month, and thereafter on every 15th day until 6-month observation period of canine retraction phase.

Radiation: Low Level Laser Therapy

Interventions

Also known as: Photobiomodulation
Buccal &palatal low level laser therapyBuccal low level laser therapy

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Complete permanent dentition (3rd molars excluded).
  • The age was ranged from 15 -25 years.
  • Malocclusion that required extraction of at least maxillary first premolars, followed by canine retraction.
  • Good oral hygiene and periodontal health.

You may not qualify if:

  • Patients who diagnosed to have an indication for non-extraction approach.
  • Serious systemic diseases and/or long term medications that could interfere with OTM.
  • Previous orthodontic treatment.
  • Poor oral hygiene or periodontally compromised patients.
  • Craniofacial anomalies or history of parafunctional habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Malocclusion

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Abdullah M Al-Haj, MSc student

    Al-Azhar University

    PRINCIPAL INVESTIGATOR
  • Farouk A Hussein, Ass.Prof

    Al-Azhar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Buccal \&palatal LLLT Group, Buccal \&palatal LLLT Group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate MSc. Student, Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt, Dentist, Ministry of Health, Yemen.

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 8, 2020

Study Start

October 15, 2016

Primary Completion

June 10, 2018

Study Completion

February 24, 2019

Last Updated

May 8, 2020

Record last verified: 2020-05