Photobiomodulation on Molar Verticalization With Mini-implant
キーワード
概要
説明
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.
日付
| 最終確認済み: | 12/31/2019 |
| 最初に提出された: | 07/23/2019 |
| 提出された推定登録数: | 07/25/2019 |
| 最初の投稿: | 07/28/2019 |
| 最終更新が送信されました: | 01/13/2020 |
| 最終更新日: | 01/17/2020 |
| 実際の研究開始日: | 01/31/2020 |
| 一次完了予定日: | 07/29/2020 |
| 研究完了予定日: | 10/14/2020 |
状態または病気
介入/治療
Procedure: Placement of the mini-implant and verticalization
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Placebo Comparator: Control (placebo) Patients in Control will receive the photobiomodulation placebo,application, but with the laser off. Procedures will be performed immediately after the application of forces (placement of elastic bandages) on the tooth, as described: Simulations will be performed with the same laser.This will require 10 seconds of application simulation per point. As 10 points will be simulated, it will take 100 seconds for this simulation.5 points lingual and 5 points at vestibular | |
| Experimental: Experimental: Experimental: Molar verticalization + PBM (n = 17 + 3) - patients will receive laser treatment (photobiomodulation) in order to modulate orthodontic movement and act on inflammation and pain. The procedures will be performed immediately after the application of forces (placement of elastic bandages) on the tooth, as described:The irradiations will be performed with the red diode laser ( = 660 nm) with 100 milliwatts output power The power of the device will be 100miliWatts and the wavelength used will be 808 nanometers (± 10nm). The optical fiber diameter of the device is 600 micrometer, therefore a spot (area) of 0.002826 centimeter2. The energy delivered per point will be 1Joule. This will require 10 seconds of application per point. As 10 points will be irradiated, the total application time will be 100 seconds and the total energy delivered will be 10Joule. The energy density will be 25 Joule / cm2 and the power density will be 35.38 Watt / cm2 |
適格基準
| 研究の対象となる年齢 | 30 Years に 30 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - 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). Exclusion Criteria: - Patients who are latex allergic, - pregnant or breastfeeding, - smokers, - 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®, |
結果
主な結果の測定
1. Radiographic measurements [through study completion on average of one year]
二次的な結果の測定
1. Pain during movement: Visual Analog Scale (VAS) [through study completion on average of one year]
2. Evaluation of cytokines [through study completion on average of one year]
3. Assess the amount of painkillers ingested [through study completion on average of one year]
4. Oral health-related quality of life (HRQoL): OHIP-14 [through study completion on average of one year]
