Two Low-level Laser Irradiation Protocols on the Rate of Canine Retraction

NCT04926389 | Unknown

• 1 other identifier: Canine retraction 2020
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Several methods aiming at the acceleration of orthodontic tooth movement have been proposed, including low-level laser therapy (LLLT), which showed promising results. However, the frequency of patient recall has been one of its major drawbacks.

Conditions

Malocclusion

Outcome Measures

Primary Outcomes (2)

• Change in rate of canine retraction

  Several landmarks will be identified on the dental cast, including the mid-palatal raphe, the most medial points on the third right and left rugae, and the cusp tips of the right and left maxillary canines. Perpendicular lines will be drawn from the medial points of the right and left third rugae, and the cusp tips of the right and left maxillary canines to the mid-palatal raphe. The antero-posterior measurements will be carried out between the canine lines and the third rugae lines bilaterally, to assess the rate of canine retraction.

  at baseline and every 3 weeks for 3 months

• change in IL-1β level in the Ginigval Crevicular Fluid

  Samples from the GCF will be collected at baseline (before the first canine retraction), in addition to days 7, 14, and 21. GCF samples will be collected from the distal crevices of the canines, in Groups A and B, on both the experimental and control sides. Measurement of IL-1β level in the GCF will be performed using an ELISA kit.

  at baseline, 7th, 17th and 21st day

Secondary Outcomes (2)

• change canine root resorption:

  at baseline and 3 months

• Change molar anchorage loss

  at baseline and every 3 weeks for 3 months

Study Arms (2)

low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks

EXPERIMENTAL

Other: low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks

low-level laser therapy applied every 3 weeks

ACTIVE COMPARATOR

Other: low-level laser therapy applied every 3 weeks

Interventions

low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks OTHER

one side of the maxillary arch will randomly receive LLLT on days 0, 3, 7, 14, and every 2 weeks thereafter and the contralateral side will serve as the controls.

low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks

low-level laser therapy applied every 3 weeks OTHER

one side will also be randomly chosen to receive LLLT every 3 weeks and the contralateral side will serve as the controls.

low-level laser therapy applied every 3 weeks

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Malocclusion requires at least the extraction of maxillary first premolars, followed by canine retraction into the extraction site.
• Normal shape and structure of the maxillary canines, with no history of root canal treatment.
• Patients with good oral hygiene, and a healthy periodontal condition.

You may not qualify if:

• Patients who underwent previous orthodontic treatment.
• Patients currently receiving drug therapy that may affect orthodontic tooth movement, e.g. hormonal therapy and corticosteroids.
• Patients with chronic diseases that may affect the rate of tooth movement.
• Pregnancy and lactation

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

Related Publications (1)

• Eid FY, El-Kenany WA, Mowafy MI, El-Kalza AR. The influence of two photobiomodulation protocols on orthodontically induced inflammatory root resorption (a randomized controlled clinical trial). BMC Oral Health. 2022 Jun 5;22(1):221. doi: 10.1186/s12903-022-02251-w.

  PMID: 35659655 DERIVED

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 15, 2021
• Study Start: January 1, 2020
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: June 15, 2021

Record last verified: 2021-06

Locations

EG (1)