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Clinical Trials/NCT04376164
NCT04376164CompletedNot Applicable

Outcome of Low-level Laser Therapy Regarding Orthodontic Leveling and Alignment of Mandibular Anterior Segment: A Controlled Clinical Appraisal

Tharwat osman Mohi Eldeen Elshehawy1 site in 1 country26 target enrollmentStarted: January 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
26
Locations
1
Primary Endpoint
Evaluation of the alignment rate of the mandibular anterior segment with and without low level laser therapy

Study Overview

Brief Summary

to evaluate the outcome of LLLT regarding leveling and alignment of the mandibular anterior segment.

Detailed Description

Thirty patients, 18 females and 12 males, were included who had Class I malocclusion with moderate mandibular crowding and an average age was 19.23 ± 3.1years.They were randomly divided into two parallel groups; a control group without laser intervention and a laser group which received LLLT. All patients followed a non-extraction approach using one category of fixed appliance and matching conventional NiTi archwire sequence during 3 months observation period. In laser group, mandibular anterior teeth were irradiated by gallium aluminum arsenide semiconductor laser with 635 nm wavelength, 6.5J/cm2energy density, for 10 seconds at 10 points (0.2 J/point) on facial and lingual aspects. This protocol was started immediately after first wire insertion and then at days 3,7,14 of the first month and repeated for additional 2 months. In both groups, relief of mandibular crowding was assessed by Little's irregularity index (LII) after 4 weeks (T1), after 8 weeks (T2), and after 12 weeks (T3) intervals. Changes in LII scores were evaluated through scanned 3D models via software. In addition, the monthly rate of OTM was calculated and compared. The level of significance was set at p ≤ 0.05.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
16 Years to 25 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Selection of participants was based on the following criteria:
  • •The age range was from 15 to 25 years.
  • •All permanent teeth erupted (3rd molar not included).
  • •Angle class I occlusion with normal facial proportions.
  • •Moderate crowding in the lower dental arch assessed by Little's irregularity index that requires treatment with fixed appliance using non-extraction approach.
  • •Good oral and general health.
  • •No previous or current periodontal disease.
  • •No systemic disease or regular medication that could interfere and\or affects orthodontic teeth movement.
  • •No evidence of craniofacial anomalies, such as cleft lip and palate or previous history of trauma, bruxism or parafunction.
  • •No previous orthodontic treatment.

Exclusion Criteria

  • •The patients were excluded from the study if they have:
  • •Severe crowding that requires an extraction approach.
  • •Blocked-out teeth that didn't allow for placement of the bracket at the initial bonding appointment.
  • •Poor oral hygiene or periodontally compromised teeth.
  • •Relevant medical history that interferes with orthodontic treatment.
  • •Craniofacial anomalies or previous history of trauma, bruxism or parafunction.
  • •Previous orthodontic treatment.
  • •The deep bite which interferes with orthodontic brackets placement.

Arms & Interventions

control group

No Intervention

was treated without laser intervention

laser group

Experimental

received low level laser therapy

Intervention: low level laser therapy (Radiation)

Outcomes

Primary Outcomes

Evaluation of the alignment rate of the mandibular anterior segment with and without low level laser therapy

Time Frame: 6 Months

Effect of the LLLT on alignment of the mandibular anterior teeth through evaluation of changes in Little's Irregularity Index (LII) scores (mm) throughout 12 weeks observation period of the study

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Tharwat osman Mohi Eldeen Elshehawy
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Tharwat osman Mohi Eldeen Elshehawy

Dentist, Ministry of Health, MSc student, Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt.

Al-Azhar University

Study Sites (1)

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