NCT04316403

Brief Summary

Erbium lasers have been suggested to accomplish corticotomy without flap reflection due to their attractive advantages. The current trial aimed to evaluate the efficacy of laser-assisted flapless corticotomy in accelerating orthodontic tooth movement. The secondary aim was to evaluate the patients' responses to laser application. It was postulated that canine retraction after laser-assisted flapless corticotomy would be accomplished within a shorter period compared with the conventional canine retraction method, with no significant degree of pain and discomfort.

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 Feb 2015

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

2.3 years

First QC Date

March 18, 2020

Last Update Submit

March 21, 2020

Conditions

Keywords

Tooth movementAcceleration of tooth movementEr:YAG laser-assisted corticotomy

Outcome Measures

Primary Outcomes (1)

  • Change in the canine retraction rate

    The distance between the first molar labial hook and the canine bracket hook was recorded using Digital Boely gauge and then this distance was divided by the time that passed between two assessment points.

    10 minutes after laser application, one, two, four, 8 and 12 weeks after laser application

Secondary Outcomes (1)

  • Change in the levels of pain and discomfort

    at the 1st day following laser application (10 minutes) and at the 3rd, 5th and 7th days following laser application

Study Arms (2)

Laser-assisted corticotomy

EXPERIMENTAL

Er:YAG laser beam was used to perform several perforations to the alveolar bone around the canine in one side of the mouth hoping that would accelerate canine retraction

Procedure: Er:YAG laser

Traditional treatment

NO INTERVENTION

Canines in this group were retracted by the conventional manner.

Interventions

Er:YAG laserPROCEDURE

This application was made before the onset of canine retraction in one side of the mouth

Laser-assisted corticotomy

Eligibility Criteria

Age16 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Class II division 1 patients requiring orthodontic treatment with fixed appliances and a need for upper first-premolar extraction using a two-step retraction technique.
  • Permanent dentition with an age range from 16 to 24 years.
  • Healthy with no systemic conditions.
  • Adequate oral hygiene and healthy periodontal tissues
  • no previous orthodontic treatment
  • Absence of canine endodontic treatment.

You may not qualify if:

  • Bimaxillary dentoalveolar severe protrusion.
  • Previous orthodontic treatment.
  • Subject with psychological abnormalities.
  • Subject with systemic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthodontic Department, University of Hama Dental School

Hama, 12JO76WH, Syria

Location

Related Publications (7)

  • Fisher MA, Wenger RM, Hans MG. Pretreatment characteristics associated with orthodontic treatment duration. Am J Orthod Dentofacial Orthop. 2010 Feb;137(2):178-86. doi: 10.1016/j.ajodo.2008.09.028.

    PMID: 20152672BACKGROUND
  • Segal GR, Schiffman PH, Tuncay OC. Meta analysis of the treatment-related factors of external apical root resorption. Orthod Craniofac Res. 2004 May;7(2):71-8. doi: 10.1111/j.1601-6343.2004.00286.x.

    PMID: 15180086BACKGROUND
  • Uribe F, Padala S, Allareddy V, Nanda R. Patients', parents', and orthodontists' perceptions of the need for and costs of additional procedures to reduce treatment time. Am J Orthod Dentofacial Orthop. 2014 Apr;145(4 Suppl):S65-73. doi: 10.1016/j.ajodo.2013.12.015.

    PMID: 24680026BACKGROUND
  • Hassan SE, Hajeer MY, Alali OH, Kaddah AS. The Effect of Using Self-ligating Brackets on Maxillary Canine Retraction: A Split-mouth Design Randomized Controlled Trial. J Contemp Dent Pract. 2016 Jun 1;17(6):496-503. doi: 10.5005/jp-journals-10024-1879.

    PMID: 27484605BACKGROUND
  • AlSayed Hasan MMA, Sultan K, Hamadah O. Low-level laser therapy effectiveness in accelerating orthodontic tooth movement: A randomized controlled clinical trial. Angle Orthod. 2017 Jul;87(4):499-504. doi: 10.2319/062716-503.1. Epub 2016 Nov 21.

    PMID: 27869476BACKGROUND
  • Hashimoto H. Effect of micro-pulsed electricity on experimental tooth movement. Nihon Kyosei Shika Gakkai Zasshi. 1990 Aug;49(4):352-61.

    PMID: 2133892BACKGROUND
  • Jaber ST, Al-Sabbagh R, Hajeer MY. Evaluation of the efficacy of laser-assisted flapless corticotomy in accelerating canine retraction: a split-mouth randomized controlled clinical trial. Oral Maxillofac Surg. 2022 Mar;26(1):81-89. doi: 10.1007/s10006-021-00963-x. Epub 2021 Apr 20.

MeSH Terms

Conditions

Malocclusion, Angle Class IIOverbite

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Samer T Jaber, DDS MSc

    PhD student, Orthodontics Department, University of Damascus Dental School

    PRINCIPAL INVESTIGATOR
  • Rabab Al-sabbagh, DDS MSc PhD

    Professor of Orthodontics, University of Hama, Hama, Syria

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2020

First Posted

March 20, 2020

Study Start

February 15, 2015

Primary Completion

June 15, 2017

Study Completion

September 15, 2017

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations