NCT04614727

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 10, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

October 23, 2020

Last Update Submit

January 25, 2021

Conditions

Dentin Hypersensitivity

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • 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

  • Schiff air score

    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 Outcomes (1)

  • Dentinal tubule occlusion

    six months

Study Arms (2)

polymeric nano calcium fluoride containing varnish, NANO SEAL.

EXPERIMENTAL
Combination Product: polymeric nano calcium fluoride containing varnish NANO SEAL

Casein Phosphopeptide Amorphous Calcium Phosphate Containing Fluoride Varnish,MI varnish

OTHER

CPP-ACP with 5%NaF

Combination Product: polymeric nano calcium fluoride containing varnish NANO SEAL

Interventions

polymeric nano calcium fluoride containing varnish NANO SEALCOMBINATION_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 varnishpolymeric nano calcium fluoride containing varnish, NANO SEAL.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

October 23, 2020

First Posted

November 4, 2020

Study Start

February 10, 2021

Primary Completion

May 10, 2021

Study Completion

June 10, 2021

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share