Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish

NCT ID: NCT04614727

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-10
• Study Completion Date: 2021-06-10

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.

Conditions

Dentin Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

polymeric nano calcium fluoride containing varnish, NANO SEAL.

Group Type: EXPERIMENTAL

polymeric nano calcium fluoride containing varnish NANO SEAL

Intervention Type: COMBINATION_PRODUCT

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.

Casein Phosphopeptide Amorphous Calcium Phosphate Containing Fluoride Varnish,MI varnish

CPP-ACP with 5%NaF

Group Type: OTHER

polymeric nano calcium fluoride containing varnish NANO SEAL

Intervention Type: COMBINATION_PRODUCT

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

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Samar Saad

OTHER

Sponsor Role: lead

Responsible Party

Samar Saad

principle investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

Polymeric Nano Calcium Fluorid

Identifier Type: -

Identifier Source: org_study_id