Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Change in dentin hypersensitivity to mechanical stimulation from baseline to post-fluoride varnish application
研究概览
简要总结
This randomized controlled clinical trial aims to determine whether different fluoride varnish formulations reduce dentin hypersensitivity (DH) in young adults diagnosed with DH. The primary purpose of this study is to evaluate the clinical effectiveness of two commercially available fluoride varnishes.
The main questions this study aims to answer are:
- Does Clinpro Clear® (aqueous base, 9,500 ppm NaF) lead to a greater reduction in dentin hypersensitivity compared with Duraphat® (rosin/resin base, 22,600 ppm NaF)?
- Do these varnish formulations improve oral health-related quality of life and patient satisfaction?
Researchers will compare a single application of Duraphat® with a single application of Clinpro Clear® to assess differences in hypersensitivity reduction, quality-of-life outcomes, and patient satisfaction.
Participants will:
- Receive one application of either Duraphat® or Clinpro Clear® under standardized clinical conditions.
- Complete baseline and post-treatment evaluations, including:
- Dentin hypersensitivity intensity using a visual analogue scale (VAS)
- Air-blast response using the Schiff scale
- Oral health-related quality of life using the OHIP-14
- Patient satisfaction using the CSAT survey
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 40 years
- •Absence of systemic diseases with oral manifestations or requiring medications with antisialagogue effects
- •Fully dentate (excluding third molars or teeth extracted for orthodontic reasons)
- •Absence of periodontal disease, or periodontal condition in a stable state
- •Presence of at least one cervical lesion with a Schiff sensitivity score ≥ 1
- •No previous treatment or restorative procedures on the target lesions (including no topical fluoride application within the last 6 months)
排除标准
- •Patients requiring long-term use of NSAIDs or other analgesic/anti-inflammatory medications
- •Patients with allergy to milk proteins
- •Patients with allergy to organic resins or pine-derived substances
- •Pregnant or breastfeeding individuals
- •Patients with fixed orthodontic appliances in place
研究组 & 干预措施
Resin/rosin-based varnish, 22,600 ppm NaF (Duraphat® Fluoride Varnish)
Application procedure:
- The tooth surface will be cleaned and saliva gently removed.
- The appropriate amount of varnish will be dispensed onto an application tray.
- The varnish will be applied with a cotton applicator, probe, or brush, forming a thin film.
- The patient will remain seated with lip retractors in place for 15 minutes.
- Patients will be instructed not to brush their teeth or chew hard foods for at least 4 hours post-application.
干预措施: Resin/rosin-based varnish, 22,600 ppm NaF (Device)
Aqueous fluoride varnish, 9,500 ppm NaF (Clinpro Clear® Fluoride Varnish)
Application procedure:
- The tooth surface will be cleaned and dried; a lip retractor will be used.
- The varnish will be expressed fully into the dispensing chamber of the unit-dose package.
- Using the applicator brush, the varnish will be applied to fully cover the hypersensitive area.
- Patients will be instructed not to touch the teeth with the tongue or attempt to remove the varnish.
- After application, patients will remain with lip retractors in place for 15 minutes.
干预措施: Aqueous fluoride varnish, 9,500 ppm NaF (Device)
结局指标
主要结局
Change in dentin hypersensitivity to mechanical stimulation from baseline to post-fluoride varnish application
时间窗: Baseline; 7 and 28 days after the intervention.
Visual Analogue Scale (VAS) With the tooth isolated and dry, a curved dental probe will be gently passed in a mesiodistal direction across the lesion area. Pain perception will be assessed using a VAS, on which the patient indicates the perceived pain intensity, ranging from no pain (0) to the worst pain imaginable (100). The score, measured on a 0-100 mm scale, will be recorded for each lesion.
Change in dentin hypersensitivity to air stimulation from baseline to post-fluoride varnish application
时间窗: Baseline; 7 and 28 days after the intervention.
Air blast test (Schiff test) An air stimulus will be applied for 4 seconds from a distance of 3-4 mm using a triple syringe with standardized air pressure (40-60 psi) at room temperature. In cases of cervical lesions on adjacent teeth, neighboring lesions will be isolated with cotton to ensure tooth-specific responses. Pain response will be assessed using the Schiff sensitivity scale: * Score 0: No response to the air stimulus. * Score 1: A response is perceived, but the subject does not request discontinuation of the stimulus and does not move away. * Score 2: A response is perceived and the subject requests discontinuation of the stimulus or involuntarily moves away. * Score 3: An intense pain response occurs, with immediate request to stop the stimulus or marked withdrawal from it.
次要结局
- Change in oral health-related quality of life from baseline to post-fluoride varnish application(Baseline; 28 days after intervention)
- Patient satisfaction following fluoride varnish application(7 days after intervention.)
- Change in oral health-related quality of life from baseline to post-fluoride varnish application(Baseline; 28 days after intervention)
- Patient satisfaction following fluoride varnish application(7 days after intervention.)
研究者
Michael Wendler Ernst
Associate Professor
University of Concepcion, Chile