Comparison of Fluoride Varnish With Two Different Desensitizers in Reducing Dentinal Hypersensitivity
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction of hypersensitivity
研究概览
简要总结
This is a single center, randomized control. Sixty eligible subjects will be recruited into 3 study treatment groups (n=20 per group) through computerized randomization. Subjects in group 1 will be treated with 8% arginine containing paste(Colgate® Sensitive Pro-Relief™), group 2 with 5% topical fluoride varnish (Acclean) and group 3 with self-adhesive resin (Seal and protect, Dentsply). The subjects in the study will be evaluated for tactile and air-blast hypersensitivity criteria at baseline, two and four weeks.
详细描述
The aim of the present study is to evaluate the efficacy of three common professionally applied desensitizing agents in the reduction of dentine hypersensitivity over a period of 4 weeks. Patients presenting to the dental clinic with Dentine hypersensitivity and fulfilling the inclusion criteria will be included in the study after taking informed consent. Participants will be divided into three groups. Sixty eligible subjects will be recruited into 3 study treatment groups (n=20 per group) through computerized randomization. Subjects in group 1 will be treated with 8% arginine containing paste(Colgate® Sensitive Pro-Relief™), group 2 with 5% topical fluoride varnish (Acclean) and group 3 with self-adhesive resin (Seal and protect, Dentsply). the subjects in the study will be evaluated for tactile and air-blast hypersensitivity criteria at baseline, two and at four weeks by another dentist who would be a blind assessor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 with age 18 and above with dentine hypersensitivity will be selected.
- •At least two hypersensitive teeth which will be sensitive to air blast (Schiff air sensitivity scores of 2 or 3) and positive tactile sensitivity assessed clinically with explorer
- •Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
排除标准
- •• Patients who would have undergone any periodontal procedure or gotten any professionally applied desensitizers in the last three months.
- •Patients having generalized sensitivity in all teeth
- •Chronic use of anti-inflammatory and analgesic medications
- •Pregnant or lactating females;
- •Any denture bridgework; active cervical caries or deep abrasion requiring Class V fillings;
- •Fractured, crowned or root filled teeth and teeth with large restorations
- •Carious teeth or cracked teeth assessed on the basis of clinical judgment
研究组 & 干预措施
Fluoride Varnish Group
5% fluoride varnish (Acclean) applied topically
干预措施: 5% fluoride varnish (Drug)
Arginine paste Group
8% arginine containing paste (Colgate® Sensitive Pro-Relief™) applied topically
干预措施: 8% arginine containing paste (Drug)
Adhesive Resin Group
Self-adhesive resin (Seal and Protect, Dentsply) applied topically
干预措施: Self-adhesive resin (Drug)
结局指标
主要结局
Reduction of hypersensitivity
时间窗: Reduction of hypersensitivity will be assessed at 2 weeks and 4 weeks
• Investigators are comparing the effectiveness of three professionally applied desensitizing agents, 8% arginine containing paste (Colgate® Sensitive Pro-Relief™), 5% fluoride varnish (Acclean) and self-adhesive resin (Seal and Protect, Dentsply) in reducing the dentine hypersensitivity immediately after application and at 2 and 4 weeks follow-up.The measurements of sensitivity will be determined by patient's response to air blast stimuli. Subjective responses will be recorded using Schiff Cold Air Sensitivity Scale which is scored as follows: 0 Subject does not respond to air stimulus, 1. Subject responds to air stimulus but does not request discontinuation of stimulus 2. Subject responds to air stimulus and requests discontinuation or moves from stimulus 3. Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus
次要结局
未报告次要终点
研究者
Muhammad Hasan Hameed
Resident investigator
Aga Khan University