Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish
- Conditions
- Dentin Hypersensitivity
- Interventions
- Combination Product: polymeric nano calcium fluoride containing varnish NANO SEAL
- Registration Number
- NCT04614727
- Lead Sponsor
- Samar Saad
- Brief Summary
The aim of this study is to evaluate the Desensitizing efficacy of polymeric nano calcium fluoride containing varnish and its implementation into clinical practice.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description polymeric nano calcium fluoride containing varnish, NANO SEAL. polymeric nano calcium fluoride containing varnish NANO SEAL - Casein Phosphopeptide Amorphous Calcium Phosphate Containing Fluoride Varnish,MI varnish polymeric nano calcium fluoride containing varnish NANO SEAL CPP-ACP with 5%NaF
- Primary Outcome Measures
Name Time Method Visual Analog Scale VAS 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 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.
- Secondary Outcome Measures
Name Time Method Dentinal tubule occlusion six months Fully open, partially occluded and fully occluded dentinal tubules. (Percentage %)