Effects of PBM on Fixed-appliance Orthodontic Patients

NCT06199674 | Recruiting

• 1 other identifier: PBMRR-HKU-143
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effects of photobiomodulation therapy (PBM) on the dental and periodontal health of patients undergoing fixed-appliance orthodontic treatment, including orthodontically induced root resorption, orthodontic pain, space closing rate, and dental microbiome profile in dental plaques.

Conditions

Orthodontics; Root Resorption

Keywords

photobiomodulation; fixed-appliance orthodontic treatment; root resorption; orthodontic pain; tooth movement

Outcome Measures

Primary Outcomes (1)

• Orthodontic-induced inflammatory root resorption (OIIRR)

  Record OIIRR by calculating the volume of craters on the root surfaces of the extracted tooth using a standard micro-CT machine after 3 months following intrusions by cantilever auxiliary arch.

  baseline, 3 months after intrusive force loading

Secondary Outcomes (3)

• Orthodontic pain

  baseline, immediately after fixed appliance placement and immediately after adjustment every month during the first year of regular orthodontic treatment

• Space closure by en masse retraction

  every month from the start of space closure to the end of closure, taking into account the very slow closure of space, assessed up to 12 months

• Microbiome profile in dental plaques

  baseline, every 3 months from the start of regular orthodontic treatment to the end of treatment process

Study Arms (2)

PBM group

EXPERIMENTAL

wear PBM device daily during the fixed-appliance orthodontic treatment

Device: photobiomodulation therapy; Other: orthodontic fixed-appliance

Control group

SHAM COMPARATOR

wear sham device daily during the fixed-appliance orthodontic treatment

Other: orthodontic fixed-appliance

Interventions

photobiomodulation therapy DEVICE

Patients in the PBM group will be delivered a portable PBM device (PBM Healing Ortho) at the beginning of orthodontic treatment and will be instructed to use it daily at home for 8 minutes (4 min per arch) after tooth brushing.

PBM group

orthodontic fixed-appliance OTHER

All eligible patients will receive orthodontic treatment with a pre-adjusted fixed appliance (0.022'' × 0.028'' slot system, MBT, 3M Unitek) provided by the same practitioner. At the start of treatment, a cantilever auxiliary arch bent with a 0.017'' × 0.025'' Stainless Steel wire (3M Unitek) will be used to apply a 100 g intrusion force to the premolars that will be extracted in 3 months. All other teeth will undergo regular orthodontic treatment with a standard archwire protocol (0.014'' NiTi, 0.016'' NiTi, 0.018'' NiTi, 0.017'' × 0.025'' NiTi, 0.019'' × 0.025'' NiTi, and 0.019'' × 0.025'' SS, 0.019'' × 0.025'' TMA) for alignment, leveling, space closure, detailing, and finishing. For en masse retraction, a 150 g force will be applied by coil springs, allowing bracket slots to slide along the 0.019'' × 0.025'' SS.

Control group; PBM group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 18 and 35 years old with permanent dentition
• Patients who undertake orthodontic treatment using fixed appliances
• Patients who require extraction of premolars in either their upper or lower dental arch
• Patients who have fair oral hygiene habits
• Patients who are systemically healthy

You may not qualify if:

• Patients with generalized dental caries and severe chronic periodontitis in stages III and IV
• Patients with congenital or severe craniofacial anomalies which necessitate orthognathic surgery
• Patients with physical or mental impairment, and those who smoke or undertake systemic medications
• Patients with current root resorption at any of the teeth
• Patients with endodontic treatment and/or large restorations on premolars to be extracted

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Root Resorption

Interventions

Low-Level Light Therapy; Orthodontic Appliances, Fixed

Condition Hierarchy (Ancestors)

Tooth Resorption; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Zhiyi Shan

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyi Shan

CONTACT

852-28590451; shanzhiy@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: January 10, 2024
• Study Start: January 20, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

HK (1)