Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish

Dentin Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04614727
• Other study ID #: Polymeric Nano Calcium Fluorid
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: June 10, 2021

Study information

• Verified date: January 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 10, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity

Intervention

Combination Product:
• polymeric 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samar Saad

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Dentinal tubule occlusion	Fully open, partially occluded and fully occluded dentinal tubules. (Percentage %)	six months