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Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04614727
Enrollment
50
Registered
2020-11-04
Start date
2021-02-10
Completion date
2021-06-10
Last updated
2021-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentin Hypersensitivity

Keywords

Dentin sensitivity ,nano calcium fluoride, nano fluorapatite,Casein Phosphopeptide Amorphous Calcium Phosphate.

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.

Interventions

COMBINATION_PRODUCTpolymeric nano calcium fluoride containing varnish NANO SEAL

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.

Sponsors

Samar Saad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale VASsix monthsfrom 0-10 Pain absent: 0 Low pain:(1-3) Moderate pain: (4-6) Intense pain: (7-9) Extremely intense pain: 10.
Schiff air scoresix monthsfrom 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

MeasureTime frameDescription
Dentinal tubule occlusionsix monthsFully open, partially occluded and fully occluded dentinal tubules. (Percentage %)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026