Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish Versus Casein Phosphopeptide Amorphous Calcium Phosphate Containing Fluoride Varnish: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Visual Analog Scale VAS
研究概览
简要总结
The aim of this study is to evaluate the Desensitizing efficacy of polymeric nano calcium fluoride containing varnish and its implementation into clinical practice.
详细描述
Increasing the demand to find a desensitizing agent that should be biocompatible, easy to apply, painless, not changing the dental color, fast onset, and maintain a long-term effect gives a highlight to the patented formula of the polymeric nano calcium fluoride which newly introduced into the practice .
OliNano SEAL is an innovative "varnish-like" protector based on a patented silicone polymer with a true nano technology that provides an exceptional adhesion to enamel and dentin without prior etching for approximately 12 months (other available products max. 2-3 months).
It consists of four components Silicone polymer provides excellent adhesion to enamel and dentine, with transparent formula. NANO-fluoroapatite flows into enamel micro cracks & seals it, penetrating into the dentinal tubules closing them eventually. As for the NANO-calcium fluoride it behaves as a fluoride reservoir, provides gradual and long-term fluoride release. The fourth component Amine fluoride (Olaflur) provides immediate fluoride ion release and accelerates natural remineralization.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with good oral hygiene.
- •The age range of 18-65 years.
- •Patients from both gender.
- •Patients suffering from pain due to dentin hypersensitivity.
- •hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bicuspids, and first molars with exposed cervical dentine).
- •non carious cervical lesions: abrasion,erosion, abfraction, and recession with cervical dentin exposure
排除标准
- •Patient with bad oral hygiene.
- •Patients with constant use of analgesic, antihistaminic, anticonvulsive, sedative, tranquilizing, or anti-inflammatory medications 72 hours before treatment and pain assessment.
- •patients having received any desensitizing treatment during the last 3 months.
- •Patients with allergy of any materials will be used in the study . teeth with pulpitis.
- •teeth with periodontal disease installed.
- •teeth exhibiting mobility (grade 2 or 3).
- •carious lesions, fractured teeth, defective restorations or prosthesis.
- •Patients with orthodontics appliance.
结局指标
主要结局
Visual Analog Scale VAS
时间窗: six months
from 0-10 Pain absent: 0 Low pain:(1-3) Moderate pain: (4-6) Intense pain: (7-9) Extremely intense pain: 10.
Schiff air score
时间窗: six months
from 0-3 0: Tooth/subject did not respond to the air stimulus. 1. Tooth/subject responded to the air stimulus but did not request discontinuation of the stimulus. 2. Tooth/subject responded to the air stimulus and requested discontinuation or moved from the stimulus. 3. Tooth/subject responded to the air stimulus, considered the stimulus to be painful, and requested discontinuation.
次要结局
- Dentinal tubule occlusion(six months)
研究者
Samar Saad
principle investigator
Cairo University