Evaluation of the Effects of Photobiomodulation on Orthodontic Movement of Molar Verticalization With Mini-implant: a Randomized Double-blind Protocol Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Radiographic measurements
研究概览
简要总结
The objective of this study will be to evaluate the effect of photobiomodulation on the acceleration of the orthodontic movement of molar verticalization and its effect on pain and inflammation of the periodontal tissues.
Thirty-four healthy patients aged 30-60 years, who need to recover the prosthetic space for oral rehabilitation after loss of the posterior inferior dental elements and inclination of the adjacent element, will be randomly divided into 2 groups: G1 (control group) - verticalization by mini-implant + PBM (photobiomodulation) simulation (placebo); G2 (experimental group) - verticalization by mini-implant + PBM. The movements will occur with the aid of mini-implants and elastomeric chains ligatures. The PBM will occur with diode laser application, 660 nm (nanometers), 100mW (milliwatts), receiving 1J(joule) per point, 10s (seconds), 10 points (5 per buccal and 5 per lingual) and radiant exposure of 25 J / cm². The crevicular gingival fluid (FGC) will be collected to analyzed Interleukins IL1β, IL-6, IL-8, IL-10(Interleukins) and TNF-α (tumor necrosis factor) by ELISA (enzyme-linked immunosorbent assay). Radiographic shots will be taken each month to ascertain the amount (in degrees) of verticalization. To evaluate the pain, the Visual Analogue Scale will be used in all the consultations, and to evaluate the quality of life, the OHIP-14 (oral health impact profile) questionnaire will be applied. Analgesics will be given and the number of drugs will be counted. If the data are normal, they will be submitted to the Student's t-test. The data will be presented as means ± SD(standard deviation) and the value of p will be defined as <0.05.
详细描述
Loss of a dental element can generate several repercussions in the stomatognathic system. According to the latest survey by the Ministry of Health, in 2010, Brazilian adults had, on average, 7 missing teeth. This loss may lead to movement of the adjacent teeth and the antagonist, which would make prosthetic rehabilitation harder to do. Anchoring systems, such as mini-implants, have been increasingly used as a treatment option because they act with heavy but controlled forces and without side effects. Recent studies have shown that photobiomodulation (PBM) can accelerate orthodontic movement in the molar intrusion. The objective of this study will be to evaluate the effect of photobiomodulation on the acceleration of the orthodontic movement of molar verticalization and its effect on pain and inflammation of the periodontal tissues.
Thirty-four healthy patients aged 30-60 years, who need to recover the prosthetic space for oral rehabilitation after loss of the posterior inferior dental elements and inclination of the adjacent element, will be randomly divided into 2 groups: G1 (control group) - verticalization by mini-implant + PBM simulation (placebo); G2 (experimental group) - verticalization by mini-implant + PBM. The movements will occur with the aid of mini-implants and elastomeric chains ligatures. The PBM will occur with diode laser application, 660 nm, 100mW, receiving 1J per point, 10s, 10 points (5 per buccal and 5 per lingual) and radiant exposure of 25 J / cm². The orthodontic forces of verticalization (corresponding to any exchange of elastomeric ligation) will be applied every 30 days and the PBM will be applied immediately, 3 and 7 days of each month, for a period of 3 months. The crevicular gingival fluid (FGC) will be collected on the 1st, 3rd and 7th days after the first activation, and then on the 3rd day of the following two months. Interleukins IL1β, IL-6, IL-8, IL-10 and TNF-α will be analyzed by ELISA. Radiographic shots will be taken each month to ascertain the amount (in degrees) of verticalization. To evaluate the pain, the Visual Analogue Scale will be used in all the consultations, and to evaluate the quality of life, the OHIP-14 questionnaire will be applied. Analgesics will be given and the number of drugs will be counted. If the data are normal, they will be submitted to the Student's t-test. The data will be presented as means ± SD and the value of p will be defined as <0.05.
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
- Double (Participant, Investigator)
盲法说明
Only one external research collaborator, with dental training, who will be responsible for the treatments (which will open the envelopes of randomization), will know which photobiomodulation treatment will be assigned to each patient. The identification of each group will be revealed by this collaborator to all involved only after statistical analysis of the data. Therefore, the researcher responsible for data collection, and the statistician will be blinded to the treatments assigned to the groups. The patient will also be blind to the type of treatment performed since the mini-implant placement treatment will be identical in both groups and the laser treatment for photobiomodulation will be simulated in the control group.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who agree and sign the informed consent
- •healthy (ASA I - negative medical history),
- •systolic blood pressure less than 140mmHg and diastolic blood pressure less than 90mmHg,
- •heart rate with 70 ± 20 beats / minute
- •requiring oral rehabilitation after loss of some posterior lower dental element (1st molar),
- •with favorable periodontal condition to the installation of mini-implants. Any questions during the research period should be informed to the researcher so that the researcher can take the appropriate measures (the latter should provide some form of personal contact).
排除标准
- •Patients who are latex allergic,
- •pregnant or breastfeeding,
- •diabetics,
- •patients undergoing head and neck radiotherapy,
- •coagulation disorders requiring antibiotic prophylaxis for placement of mini-implants, with absolute indication for use of local anesthetics with vasoconstrictors,
- •with decompensated systemic disease,
- •with systemic or local infection (periodontitis or periodontal abscess),
- •who have used anti-inflammatory drugs in the last 3 months before orthodontic treatment.
- •Patients who may have any complications during the research period, such as allergic reactions to any of the materials used, allergic reaction to paracetamol®,
结局指标
主要结局
Radiographic measurements
时间窗: through study completion on average of one year
Radiographic measurements to assess movement rate through tooth angulation versus time at baseline, 30, 60 and 90 days after treatment, Movement rate - With the aid of a ruler (Morelli, Sorocaba, SP, Brazil) and a protractor (transparent Waleu 10290001®), radiographic measurements will be taken at baseline, 30, 60 and 90 days to ascertain the amount (in degrees) of verticalization, using as reference the line of the occlusal plane and the long axis of the inclined tooth (García, 2017). These measurements will be recorded in degrees in each patient's chart for further analysis.
次要结局
- Assess the amount of painkillers ingested(through study completion on average of one year)
- Oral health-related quality of life (HRQoL): OHIP-14(through study completion on average of one year)
- Pain during movement: Visual Analog Scale (VAS)(through study completion on average of one year)
研究者
Anna Carolina Ratto Tempestini Horliana
PhD, clinical professor
University of Nove de Julho