Photobiomodulation Before or After In-office Tooth Whitening for Sensitivity Reduction: a Blinded, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Tooth sensitivity
研究概览
简要总结
The objective is to evaluate the effect of photobiomodulation (PBM) applied before or after in-office tooth whitening in reducing tooth sensitivity (TS) and color change. Sixty-six patients aged between 18 and 28 years old, of both sexes, with good oral and general health will be selected for the study. A randomization process will be carried out to allocate participants into the three different groups: FBM-Before, FBM-After and Placebo. All groups will undergo in-office whitening treatment with 35% hydrogen peroxide (Whitness HP, FGM, Joinville, SC, Brazil). Three whitening sessions will be carried out, considering a seven-day interval between sessions. TS will be measured using a visual analogue scale (VAS) and a five-point numerical rating scale (NRS), while shade change will be assessed using a spectrophotometer: before the bleaching treatment (T0), after the first (T1), second (T2). ) and third (T3) weeks of treatment and 30 days (T4) after the end of the bleaching treatment.
详细描述
Ethical Considerations This research project will adhere to the recommendations of CONSORT (Consolidated Standards of Reporting Trials) (Turner et al., 2012). Participants will be fully informed about the risks, methods, and objectives of this study, and their participation will require the signing of a free and informed consent form (ICF), in accordance with the Declaration of Helsinki (World Medical Association, 2013).
All collected data will be used exclusively for scientific purposes, and the identity of the participants will remain confidential. Participation in the study may be withdrawn at any time, and confidentiality will be assured even in the event of treatment discontinuation.
Sample Size Calculation The sample size for this study was determined using GPower 3.1 (Heinrich-Heine-Universität Düsseldorf, Germany). The calculation was based on a prior study by Moosavi et al. (2016), which employed a methodology similar to that proposed in this investigation. The sample size was calculated with a statistical power of 80%, an alpha error of 5%, and a predicted dropout rate of 20%. The resulting sample size for this study is 22 patients per group.
Study Design The clinical study will be a randomized, parallel, double-blind, placebo-controlled trial. Randomization will be performed to allocate participants into three different groups: PBM-Before, PBM-After, and Placebo.
All groups will undergo in-office whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM, Joinville, SC, Brazil). Three whitening sessions will be performed, with a seven-day interval between sessions.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers of both sexes, in good oral and general health.
- •The upper right canine should be classified as color A2 or darker, according to the Vita Classical scale (VITA Zahnfabrik, Bad Sackingen, Germany).
排除标准
- •Active caries or periodontal disease
- •Visible cracks in upper or lower anterior teeth
- •Evident malocclusion, restorations and prosthetics in anterior teeth
- •Gastroesophageal disorders
- •Severe internal discoloration of the tooth (tetracycline, fluorosis or pulped teeth)
- •Exposure dentin in anterior and/or posterior teeth
- •Parafunctional habits
- •Tooth sensitivity, previous bleaching treatment or orthodontic treatment
- •Pregnant or breastfeeding women
研究组 & 干预措施
Placebo
Only in-office tooth whitening will be performed. Patients will not undergo additional treatments, however, a simulation of the application of FBM will be performed before and after each CD session. The low-power laser (Therapy EC, DMC, São Carlos, SP, Brazil) will be positioned perpendicularly, in contact, over the cervical and apical region of each tooth included in the whitening treatment. During the simulation, the equipment will not be activated, that is, irradiation will not be carried out.
干预措施: Photobiomodulation with low power laser (Other)
FBM-Before
Low power laser will be used immediately before CD. The energy supplied to each tooth will be 4J, using infrared light (IF) at 808 nm (± 10 nm) at two perpendicular points (located in the apical and cervical region) on the buccal surface of the incisors, canines and premolars. The laser will be operated in continuous mode and an energy of 2J will be applied to each point. The protocol that will be used to treat tooth sensitivity was recommended by the equipment manufacturer. Immediately after each whitening treatment session, a FBM simulation will be performed, in the same way as described for the Placebo group.
干预措施: Photobiomodulation with low power laser (Other)
FBM-After
The low-power laser will be used immediately after tooth whitening. The FBM protocol will occur in the same way as described for the FBM-Before group. The FBM simulation will occur before the CD session begins and will occur in the same way as described for the Placebo group.
干预措施: Photobiomodulation with low power laser (Other)
结局指标
主要结局
Tooth sensitivity
时间窗: 21 days
To assess pain sensitivity, patients will be instructed to fill out a form to record tooth sensitivity, based on individual pain perception. This form will be delivered at each whitening session, and will be returned to the researcher at the next appointment, that is, always one week after each whitening session.
次要结局
- Color change(51 days)
研究者
Cecy Martins Silva
Dra
Universidade Federal do Para