Effects of Photobiomodulation Therapy (PBM) on Dental and Periodontal Health of Patients Undergoing Fixed-appliance Orthodontic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Orthodontic-induced inflammatory root resorption (OIIRR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PBM group
wear PBM device daily during the fixed-appliance orthodontic treatment
干预措施: orthodontic fixed-appliance (Other)
PBM group
wear PBM device daily during the fixed-appliance orthodontic treatment
干预措施: photobiomodulation therapy (Device)
Control group
wear sham device daily during the fixed-appliance orthodontic treatment
干预措施: orthodontic fixed-appliance (Other)
结局指标
主要结局
Orthodontic-induced inflammatory root resorption (OIIRR)
时间窗: baseline, 3 months after intrusive force loading
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.
次要结局
- Microbiome profile in dental plaques(baseline, every 3 months from the start of regular orthodontic treatment to the end of treatment process)
- 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)
研究者
Zhiyi Shan
Clinical Assistant Professor
The University of Hong Kong