Evaluation of diode laser application on both buccal and lingual surfaces in single and multiple sessions in managing dentinal hypersensitivity: A 12-month randomized controlled clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- To evaluate the effect of Diode laser application on both buccal and lingual
研究概览
简要总结
Aim: This study will be performed to evaluate the effect of Diode laser application on both buccal and lingual surfaces of teeth, in single or multiple sessions, in management of dentin hypersensitivity, over a period of 12 months. Methods: Evaporative (air blast) and tactile stimuli will be used to evaluate cervical dentin hypersensitivity, using a visual analogue scale (0 to 10 cm) in all patients. A total of 116 hypersensitive teeth will be randomly divided into 4 groups: Group 1: Diode laser application in a single session on the buccal surface only. Group 2: Diode laser application in 3 sessions (every 48 hours) on buccal surface only. Group 3: Diode laser application in a single session on both buccal and lingual/palatal surfaces. Group 4: Diode laser application in 3 sessions on both buccal and lingual surfaces of hypersensitive teeth. Results and follow up: After completion of treatment for each respective group, DH will be evaluated immediately after treatment and at follow ups (1 week, 1, 3, 6, and 12 months) using evaporative and tactile tests. The subject response will be quantified by using a visual analog scale in which the patient places a mark on a 10 cm line labeled from “no sensitivity (0) to maximum sensitivity” (10). The obtained data will be analysed using F tests - ANOVA: Fixed effects, omnibus, one-way in SPSS Version 22 at a significance level of P < .05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient giving informed consent for the study.
- •1 Patients aged 18 years or more 2 Patients diagnosed with dentinal hypersensitivity using tactile and evaporative stimuli, only on buccal surfaces of teeth 3 Patients who were able to understand visual analogue pain scale (VAS) • Patients who reported minimum score of 3 on VAS score after tactile and evaporative stimulus • Good oral hygiene • Patients in good general health (ASA classification 1 or 2).
排除标准
- •Patient not willing to give consent.
- •1 Patients undergoing orthodontic treatment.
- •2 Pregnant or lactating women.
- •3 Patients with systemic conditions affecting dentinal hypersensitivity.
- •4 Patients who have undergone recent treatment for dentinal hypersensitivity within 6 months.
- •• Patients with teeth showing evidence of irreversible pulpitis or necrosis • Patients with carious lesions, defective restorations, facets of attrition, premature contact, cracked enamel, active periodontal disease, use of daily doses of medications.
结局指标
主要结局
To evaluate the effect of Diode laser application on both buccal and lingual
时间窗: 1 week, 1, 3, 6, and 12 months
surfaces of teeth in single or multiple sessions in management of DH.
时间窗: 1 week, 1, 3, 6, and 12 months
次要结局
- 1) To evaluate the effect of Diode laser application on only buccal surfaces of teeth in(single or multiple sessions in management of DH.)
研究者
Saanya
JCD Dental College, Sirsa