Micro-osteoperforation Versus Photobiomodulation Therapy for Accelerating Maxillary Canine Retraction: A Three-Arm Parallel Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
研究概览
简要总结
Orthodontic treatment often requires moving the upper canine teeth (the pointed teeth) into the spaces left after removing premolar teeth. This process is usually slow and can take many months, making the total treatment time longer.This study will compare two techniques that may speed up this tooth movement:
Micro-osteoperforation (MOP): A minimally invasive procedure in which a small device is used to create tiny holes in the jawbone near the canine tooth under local anesthesia. These micro-perforations stimulate the bone to remodel faster, which allows the tooth to move more quickly.
Photobiomodulation therapy (PBMT) / Low-Level Laser Therapy (LLLT): A painless, non-invasive technique that uses a low-power laser light applied to the gum tissue near the canine tooth. The laser energy stimulates cells in the bone and supporting tissues to accelerate tooth movement without any cutting or drilling.
This trial will randomly assign eligible patients into one of three groups: MOP, LLLT, or a control group receiving standard orthodontic treatment only. Each group will contain 25 participants (75 total). The main goal is to measure and compare how fast the upper canine tooth moves in each group over the first month and until the space is fully closed. The study will also measure the effect of age and sex on the results. The findings will help orthodontists choose the best, fastest, and most comfortable method for each patient to shorten overall treatment time
详细描述
Background:
Maxillary canine retraction following first premolar extraction represents the most time-consuming phase of fixed orthodontic therapy, often requiring five to eight months under conventional mechanics. Prolonged treatment duration is associated with increased risks of root resorption, periodontal deterioration, white spot lesions, and reduced patient compliance. Several adjunctive techniques have been proposed to accelerate orthodontic tooth movement (OTM), of which micro-osteoperforation (MOP) and photobiomodulation therapy (PBMT) have demonstrated the most consistent clinical evidence. However, no randomized controlled trial has directly compared these two modalities against each other and against a conventional control under standardized conditions.
Rationale for study design:
A three-arm parallel-group randomized controlled clinical trial (RCT) design was selected in preference to a split-mouth design. Although split-mouth designs offer statistical efficiency, the comparison of MOP and PBMT in a split-mouth model is methodologically inappropriate due to: (1) the risk of contralateral biological cross-contamination from the Regional Acceleratory Phenomenon (RAP) induced by MOP; (2) the potential for sub-therapeutic photon scatter from LLLT irradiation reaching contralateral tissues; and (3) the ethical concern of exposing individual patients to two mechanistically distinct and invasive/non-invasive interventions simultaneously. A parallel-arm design with a true control group eliminates these confounders and allows independent evaluation of each intervention's efficacy.
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The participant cannot be blinded - they know whether they received drilling (MOP) or laser (LLLT) The operator cannot be blinded - they perform the procedure The outcomes assessor (who measures canine movement on study models) can and must be blinded - this is your main protection against measurement bias
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 40 years at the time of enrollment
- •Systemically healthy with no chronic medical conditions affecting bone metabolism or wound healing
- •Requiring bilateral maxillary first premolar extraction as part of a comprehensive fixed orthodontic treatment plan
- •Class I or mild Class II malocclusion requiring maximum anchorage canine retraction
- •Fully erupted maxillary permanent dentition with no missing teeth other than planned extraction teeth
- •Good oral hygiene (Plaque Index ≤ 1) and healthy periodontal status (probing depth ≤ 3 mm, no bleeding on probing)
- •No previous orthodontic treatment
- •Willing to attend all scheduled appointments and comply with study protocol
- •Able to provide written informed consent
排除标准
- •Systemic diseases affecting bone metabolism including osteoporosis, osteopenia, diabetes mellitus, thyroid disorders, or autoimmune conditions
- •Current use of medications affecting bone remodeling including corticosteroids, bisphosphonates, non-steroidal anti-inflammatory drugs (NSAIDs), or vitamin D supplements
- •Current or recent smokers (within the past 6 months)
- •Pregnant or breastfeeding women
- •History of head and neck radiation therapy
- •Periodontal disease or active dental infection at the time of enrollment
- •Skeletal Class III malocclusion or severe Class II requiring surgical intervention
- •Previous orthodontic treatment or orthognathic surgery
- •Craniofacial syndromes or cleft lip and palate
- •Photosensitivity disorders or use of photosensitizing medications (relevant to LLLT group)
- •Coagulation disorders or anticoagulant therapy (relevant to MOP group)
- •Uncooperative patients or those unable to maintain adequate oral hygiene throughout treatment
- •Parafunctional habits such as severe bruxism or tongue thrusting'