Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish

January 25, 2021 updated by: Samar Saad

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale VAS
Time Frame: six months
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
Time Frame: six months

from 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.
six months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samar Saad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 10, 2021

Primary Completion (Anticipated)

May 10, 2021

Study Completion (Anticipated)

June 10, 2021

Study Registration Dates

First Submitted

October 23, 2020

First Submitted That Met QC Criteria

October 28, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Polymeric Nano Calcium Fluorid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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