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Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish

S

Samar Saad

Status

Unknown

Conditions

Dentin Hypersensitivity

Treatments

Combination Product: polymeric nano calcium fluoride containing varnish NANO SEAL

Study type

Interventional

Funder types

Other

Identifiers

NCT04614727
Polymeric Nano Calcium Fluorid

Details and patient eligibility

About

The aim of this study is to evaluate the Desensitizing efficacy of polymeric nano calcium fluoride containing varnish and its implementation into clinical practice.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

50 participants in 2 patient groups

polymeric nano calcium fluoride containing varnish, NANO SEAL.
Experimental group
Treatment:
Combination Product: polymeric nano calcium fluoride containing varnish NANO SEAL
Casein Phosphopeptide Amorphous Calcium Phosphate Containing Fluoride Varnish,MI varnish
Other group
Description:
CPP-ACP with 5%NaF
Treatment:
Combination Product: polymeric nano calcium fluoride containing varnish NANO SEAL

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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