Effect of Low-Level Laser Therapy on Stability During Retention Phase.

NCT05723094 | Unknown FDA Device

• 1 other identifier: USM/JEPeM/22060411
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The biggest problem in the orthodontic process is the pain and the long duration of treatment, which is also generally divided into 2 phases, namely the orthodontic tooth movement (OTM) and the retention phase. In recent decades, low-level-laser therapy has gained attention because it is non-invasive, inexpensive, relieves pain and has no significant adverse effects. Low-level-laser therapy (LLLT) has been proved to effectively induce and accelerate the remodeling process of alveolar bone by increasing the number of osteoblasts and osteoclasts. Therefore, LLLT is widely used in OTM to accelerate tooth displacement, but there are few studies and limited evidence on the stability whether it can strengthen and shorten the retention stage to avoid relapse. Thus, the purpose of this study is to investigate the stability after orthodontic treatment by observing the substantial influence of low-level-laser as during retention phase. Research Question(s) 1\. Does the low-level laser treatment can enhance stability and shorten retention time after orthodontic treatment or not will be demonstrated through 3 aspects：

1. 1.The Incisor Irregularities Index between laser and control group after application of LLLT at debond (0), 6 and 12 months of retention
2. 2.The interarch dimension: intercanine width, intermolar width, interpremolar width, arch length between laser and control group after application of LLLT at debond (0), 6 and 12 months of retention
3. 3.The overjet and overbite between laser and control group after application of LLLT at debond (0), 6 and 12 months of retention
4. 4.To compare the Incisor Irregularities Index between laser and control group after application of LLLT at debond (0), 6 and 12 months of retention
5. 5.To compare the interarch dimension: intercanine width, intermolar width, interpremolar width, arch length between laser and control group after application of LLLT at debond (0), 6 and 12 months of retention To compare the overjet and overbite between laser and control group after application of LLLT at debond (0), 6 and 12 months of retention

Conditions

Orthodontic Retainers; Laser Therapy

Outcome Measures

Primary Outcomes (3)

• Incisor Irregularities Index

  To compare the changes in the Incisor Irregularities Index between the laser and control group after the application of LLLT at debond (0), 6, and 12 months of retention.

  12 months

• The interarch dimension: intercanine width, intermolar width, interpremolar width, arch length

  To compare the changes in the interarch dimension: intercanine width, intermolar width, interpremolar width, arch length between laser and control group after application of LLLT at debond (0), 6 and 12 months of retention

  12 months

• Overjet and overbite

  To compare the changes in the overjet and overbite between laser and control group after application of LLLT at debond (0), 6 and 12 months of retention

  12 months

Study Arms (2)

Retention Laser Group (LG)

EXPERIMENTAL

Before the orthodontic retention phase, the Ga-Al-As diode laser(Ilase, USA) was applied to the experimental group.

Radiation: Ga-Al-As diode laser (Ilase, USA)

Retention Control Group (CG)

PLACEBO COMPARATOR

Before the orthodontic retention phase, those who did not apply the Ga-Al-As diode laser (Ilase, USA) were the control group.

Other: placebo

Interventions

Ga-Al-As diode laser (Ilase, USA) RADIATION

The laser parameter used in previous study： Laser type：Ga-Al-As Wavelength：940 nm Emission type：Continuous Irradiation dosage/per tooth：75J/cm2 Application technique：Direct contact with the mucosa Exposure time per point：6 second Laser classification：3B Laser application time：Once in a month (4-week intervals) for the maxilla and mandibular incisors and canines Output：100Mw Diameter of the optical fiber：0.04 cm2

Retention Laser Group (LG)

placebo OTHER

Before the orthodontic retention phase, those who did not apply the Ga-Al-As diode laser (Ilase, USA) were the control group.

Retention Control Group (CG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient treated with laser and non-laser application during orthodontic treatment as in previous study
• The patient presents with mild to moderate crowding malocclusion with extraction of all 1st premolars and using conventional brackets
• The treatment of fixed appliances involving both arches
• \. Patients wearing vacuum formed retainers.
• \. Patients are compliance towards retainer wear with no history of retainer lost
• \. All permanent teeth erupted except for third molars.

You may not qualify if:

• Age less than 18 years old
• Active caries and Periodontal disease
• Use any long-term use of analgesics or drugs that affect the function of the central nervous system.
• \. Non-compliance patients in term of wearing retainers
• Withdrawal criteria:
• Any patient who would like to withdraw from the experiment can do without their treatment being compromised.
• Patients who do not comply with the retainer requirements during the retention phase will be considered an automatic withdrawal from the research and their data will not be accepted.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Wang Yanpei

Kubang Kerian, Kelantan, 16150, Malaysia

RECRUITING

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Study Officials

• Norma Binti Ab Rahman, MASTER

  SCHOOL OF DENTAL SCIENCES

  STUDY DIRECTOR

Central Study Contacts

WANG YANPEI, MSc.

CONTACT

+601127069413; wangyanpei@student.usm.my

Mohamad Arif Bin Awang Nawi, Ph.D.

CONTACT

+60199322962; mohamadarif@usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2023
• First Posted: February 10, 2023
• Study Start: December 18, 2022
• Primary Completion: October 31, 2023
• Study Completion: November 30, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)