Laser in Orthodontic Leveling and Alignment

NCT04376164 | Completed

• 1 other identifier: 101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Malocclusion

Keywords

Low-level laser therapy; Orthodontic Tooth Movement; Leveling and Alignment; Little Irregularity Index.

Outcome Measures

Primary Outcomes (1)

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

  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

  6 Months

Study Arms (2)

control group

NO INTERVENTION

was treated without laser intervention

laser group

EXPERIMENTAL

received low level laser therapy

Radiation: low level laser therapy

Interventions

low level laser therapy RADIATION

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

Also known as: photobiomodulation

laser group

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tharwat osman Mohi Eldeen Elshehawy: lead

Study Sites (1)

Al-Azhar university

Cairo, 11751, Egypt

Location

MeSH Terms

Conditions

Malocclusion

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• tharwat O elshehay, MSc student

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

Model Details: control group laser group

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 6, 2020
• Study Start: January 1, 2018
• Primary Completion: June 10, 2018
• Study Completion: July 15, 2018
• Last Updated: May 6, 2020

Record last verified: 2020-05

Locations

EG (1)