Clinical trial NCT06199674: Effects of PBM on Fixed-appliance Orthodontic Patients
Official title: Effects of Photobiomodulation Therapy (PBM) on Dental and Periodontal Health of Patients Undergoing Fixed-appliance Orthodontic Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthodontics
Root Resorption
Keywords: photobiomodulation
fixed-appliance orthodontic treatment
root resorption
orthodontic pain
tooth movement
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Photobiomodulation therapy (PBM) is a non-invasive, adjunctive medical treatment that has promising effects on various dental and oral conditions, including controlling inflammation, promoting wound healing, and relieving pain. While animal studies have explored PBM therapy in orthodontics for accelerating tooth movement, preventing root resorption, alleviating pain, and controlling periodontal inflammation, clinical studies with high-quality evidence remain limited. Therefore, a randomized controlled trial (RCT) will be conducted to investigate the effects of a portable PBM device on the dental and periodontal health of patients undergoing fixed-appliance orthodontic treatment. This two-arm RCT will be conducted with a triple-blinded and parallel study design in a 1:1 ratio. Fifty orthodontic patients will be recruited at the Prince Philip Dental Hospital following the eligibility criteria from Jan. 2024 to Jan. 2026 (24 months) and evenly distributed to the two arms. Randomization and allocation will be conducted by a statistician who will not participate in the intervention and outcome assessment process using computer software. Participants in the PBM group will be required to wear a PBM device, while those in the control group will receive a sham device with an identical appearance to the PBM device but without light irradiation. All participants must wear their assigned device daily for 8 minutes (4 minutes for the upper and lower dental arches each) after brushing their teeth during the process of fixed-appliance orthodontic treatment. The allocation sequences will be concealed in a batch of opaque envelopes. Patients and the outcome assessor will be blinded to the allocation sequence. This protocol is proposed in compliance with the Declaration of Helsinki and the ICH-Good Clinical Practice (GCP) Guideline. The study will be conducted and reported according to the Consolidated Standards of Reporting Trials (CONSORT) guideline. Written consent will be obtained from all subjects.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Orthodontic-induced inflammatory root resorption (OIIRR)
timeFrame: baseline, 3 months after intrusive force loading
Secondary outcomes:
measure: Orthodontic pain
timeFrame: baseline, immediately after fixed appliance placement and immediately after adjustment every month during the first year of regular orthodontic treatment
measure: Space closure by en masse retraction
timeFrame: 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
measure: Microbiome profile in dental plaques
timeFrame: baseline, every 3 months from the start of regular orthodontic treatment to the end of treatment process
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Zhiyi Shan
role: PRINCIPAL_INVESTIGATOR
References: