Evaluation of Tooth Sensitivity After Scaling and Root Planing Treated With Photobiomodulation: a Randomized Controlled Double-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Pain (VAS) in baseline
研究概览
简要总结
One hundred twenty patients with dentin sensibility after non-surgical scaling and root planning (SRP) will be randomly included in 2 groups: Experimental Group: SRP+ Photobiomodulation (PBM) (660nm, 100W, area 0,5cm2, 200w/cm2, 30 seconds, 3 J, 6J/cm2. The study's primary outcome will be the assessment of dentinal sensitivity after 7 days of RAR measured with the visual analog scale (VAS). The cutoff of VAS is 3. The impact of oral health on the participant's quality of life will also be assessed with the OHIP-14 questionnaire. Analgesics (paracetamol) will be prescribed as needed, and the amount of medication will be calculated. These outcomes will be evaluated after 7 days and 1 month of application
详细描述
Objective
To evaluate tooth sensitivity after photobiomodulation in sensitive scaling and root planning treated teeth. Study design: Randomized, controlled, double-blind split-mouth clinical trial. Methods: One hundred twenty patients with dentin sensibility after non-surgical scaling and root planning (SRP) will be randomly included in 2 groups: Experimental Group: SRP+ Photobiomodulation (PBM). The dosimetric parameters for the treatment included a wavelength of 660 nm applied in continuous mode with a radiant power of 100 mW (0.1 W). The irradiance ranged from 35.385 mW/cm² to 35 W/cm², with a beam area of 0.002826 cm². Each point received an exposure time of 30 seconds, resulting in a radiant exposure of 1.061 J/cm² and a total radiant energy of 3 J. The procedure involved six irradiated points per tooth, distributed across the vestibular surface (apical, middle, and cervical regions) and the palatal surface. The application technique was performed in contact, maintaining a 90-degree angle to the surface. The treatment consisted of a single session.The primary outcome of the study will be the assessment of dentinal sensitivity after 7 days of RAR measured with the visual analog scale (VAS). The cutoff of VAS is 3. Also, it will be assessed the impact of oral health on the participant's quality of life, with the OHIP-14 questionnaire. The use of analgesics (paracetamol) will be prescribed as needed and the amount of medication will be calculated. These outcomes will be evaluated after 7 days and 1 month of application. If the data are normal, they will be submitted to the ANOVA test - one way. Data will be presented as means ± SD and the p-value will be set to < 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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Immediately after periodontal treatment, the researcher responsible for applying the FBM will remove and open 1 envelope and perform the indicated procedure (FBM or simulation). Only this researcher will know the intervention applied to each patient. All other investigators will be blinded to the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 18 or older,
- •diagnosed with periodontitis and experiencing dentin hypersensitivity greater than three on the VAS scale caused by a UNC-15 periodontal probe.
- •both male and female patients were included,
- •without comorbidities.
排除标准
- •Patients taking medications that affect gingival metabolism (e.g., cyclosporine, phenytoin, nifedipine), inflammation (e.g., corticosteroids, anti-inflammatories), or pain (analgesics/NSAIDs),
- •history of photosensitivity
- •allergies to any medications used in the study.
- •patients who experienced any complications during the study,
- •allergic reactions to materials used or to paracetamol®
- •Those who took any medication not provided in the study were also excluded.
研究组 & 干预措施
Intervention group
Intervention Group - RAR + FBM (n=56): The researcher responsible for FBM will remove the randomization envelope and apply Laser Therapy XP. All dosimetric parameters, details of sessions, and the number of FBM applications are presented in the project.
干预措施: Photobiomodulation (Device)
Control Group
Control Group - RAR + FBM simulation (n=56): Simulation of the use of FBM will be carried out identically to the Experimental group. The person responsible for applying the FBM will simulate irradiation by positioning the devices in the same locations described for the FBM group, however, the laser pointer will be turned off and the sound of the device will be recorded to mimic the use of the equipment and the participant will not identify the group to be used. who belongs. In this trial, we have no criteria for discontinuing or modifying allocated interventions because no harm is expected with this intervention. The study flowchart presents the details of the project
干预措施: simulation of Photobiomodulation (Device)
结局指标
主要结局
Pain (VAS) in baseline
时间窗: baseline
It will be evaluated through the application of the Visual Analog Scale (VAS) in which we will have a ruler with a length of 10 cm, without markings. One of the extremes is marked "0", and the other "100" which means respectively "no pain" and "unbearable pain". This ruler will be the same for all participants (a plasticized ruler where the patient marks with a permanent pen the amount of pain felt at that moment and this amount is measured in millimeters and the value noted in the patient's chart). Instructions on marking will always be given to the patient by the same operator. Each patient will be instructed to mark with a vertical line the point that best corresponds to the intensity of pain at the time of assessment . Without the presence of the patient, the operator will always measure with the same ruler, recording this data on the cards. This analysis will occur on all queries.
Pain (VAS) in 7 days
时间窗: 7 days after treatment
It will be evaluated through the application of the Visual Analog Scale (VAS) in which we will have a ruler with a length of 10 cm, without markings. One of the extremes is marked "0", and the other "100" which means respectively "no pain" and "unbearable pain". This ruler will be the same for all participants (a plasticized ruler where the patient marks with a permanent pen the amount of pain felt at that moment and this amount is measured in millimeters and the value noted in the patient's chart). Instructions on marking will always be given to the patient by the same operator. Each patient will be instructed to mark with a vertical line the point that best corresponds to the intensity of pain at the time of assessment . Without the presence of the patient, the operator will always measure with the same ruler, recording this data on the cards. This analysis will occur on all queries.
Pain (VAS) in 30 days
时间窗: 30 days after treatment
It will be evaluated through the application of the Visual Analog Scale (VAS) in which we will have a ruler with a length of 10 cm, without markings. One of the extremes is marked "0", and the other "100" which means respectively "no pain" and "unbearable pain". This ruler will be the same for all participants (a plasticized ruler where the patient marks with a permanent pen the amount of pain felt at that moment and this amount is measured in millimeters and the value noted in the patient's chart). Instructions on marking will always be given to the patient by the same operator. Each patient will be instructed to mark with a vertical line the point that best corresponds to the intensity of pain at the time of assessment . Without the presence of the patient, the operator will always measure with the same ruler, recording this data on the cards. This analysis will occur on all queries.
次要结局
- Rescue medication at 30 days(30 days after treatment)
- Rescue medication at baseline(baseline)
- Rescue medication at 7 days(7 days after treatment)
研究者
Anna Carolina Ratto Tempestini Horliana
Clinical Professor
University of Nove de Julho