Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish

Study Overview
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Brief Summary
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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
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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.

Official Title
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Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish Versus Casein Phosphopeptide Amorphous Calcium Phosphate Containing Fluoride Varnish: Randomized Clinical Trial

Conditions
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Dentin Hypersensitivity

Intervention / Treatment
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* Combination Product: polymeric nano calcium fluoride containing varnish NANO SEAL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: polymeric nano calcium fluoride containing varnish, NANO SEAL.<br> | Combination Product: polymeric nano calcium fluoride containing varnish NANO SEAL<br>* 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.<br>|
| Other: Casein Phosphopeptide Amorphous Calcium Phosphate Containing Fluoride Varnish,MI varnish<br>CPP-ACP with 5%NaF | Combination Product: polymeric nano calcium fluoride containing varnish NANO SEAL<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale VAS | from 0-10 Pain absent: 0 Low pain:(1-3) Moderate pain: (4-6) Intense pain: (7-9) Extremely intense pain: 10. | six months | 
| Schiff air score | from 0-3 0: Tooth/subject did not respond to the air stimulus. Tooth/subject responded to the air stimulus but did not request discontinuation of the stimulus. Tooth/subject responded to the air stimulus and requested discontinuation or moved from the stimulus. Tooth/subject responded to the air stimulus, considered the stimulus to be painful, and requested discontinuation. | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dentinal tubule occlusion | Fully open, partially occluded and fully occluded dentinal tubules. (Percentage %) | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dentin sensitivity ,nano calcium fluoride, nano fluorapatite,Casein Phosphopeptide Amorphous Calcium Phosphate.