Longevity Of Desensitizing Efficacy Of Dentifrices Containing Fluoro Calcium Phosphosilicate And Calcium Sodium Phosphosilicate: A 6 Months Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Decrease in sensitivity levels from baseline
研究概览
简要总结
The study duration will be 6 months (26 weeks), in which sensitivity scores will be measured at baseline, at 21 days (3 weeks), at 3 months (13 weeks) and 6 months (26 weeks).
Each participant will be given respective dentifrice along with a soft-bristled toothbrush and will be instructed to apply dentifrice in an amount equal to about half the length of the bristle head and will also be instructed to brush for 2 min and no more than a total of 2 times/day. Participants will be directed to refrain from any other dentifrice or mouth rinse during the study. Participants will be recalled at 21 days, 3 months, and 6 months to record the VAS scores for subjective, tactile and thermal sensitivity. Sensitivity will be measured using a 10 cm VAS score, with the score of 0 being a no-pain response and a score of 10 being extreme pain or discomfort. The data will be subjected to statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with VAS score of more than or equal to 4 to subjective, tactile and thermal sensitivity in at least two teeth at the qualifying visit were considered eligible for the study.
- •Patients with complaint of sensitivity to stimuli like cold, sweet, sour.
- •Teeth with enamel loss and cementum loss.
排除标准
- •Patients with age below 30 years and above 65 years.
- •Subjects with a history of allergy to any of the drugs or chemicals used in the study.
- •Patients with lingering pain.
- •Presence of any large or defective restorations, cracked enamel or caries on the hypersensitive tooth.
- •Dental pathology causing pain similar to dentin hypersensitivity.
- •Patients who are using analgesic, steroid therapy and anti-inflammatory medication.
- •Patients who had undergone periodontal surgery within last three months.
结局指标
主要结局
Decrease in sensitivity levels from baseline
时间窗: Decrease in sensitivity levels at baseline, at 3 weeks, at 13 weeks, at 26 weeks
次要结局
- maintenance of decreased sensitivity levels(after 21 days, at 3 months, at 6 months)
研究者
Dr Sahithi Pamidimukkala
GITAM Dental College and Hospital Gandhinagar Campus, Rushikonda, Visakhapatnam, Andhra Pradesh 530045