Back to resultsDesensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish
Primary Purpose
Dentin Hypersensitivity
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
polymeric nano calcium fluoride containing varnish NANO SEAL
Sponsored by
About this trial
This is an interventional treatment trial for Dentin Hypersensitivity focused on measuring Dentin sensitivity ,nano calcium fluoride, nano fluorapatite,Casein Phosphopeptide Amorphous Calcium Phosphate.
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
polymeric nano calcium fluoride containing varnish, NANO SEAL.
Casein Phosphopeptide Amorphous Calcium Phosphate Containing Fluoride Varnish,MI varnish
Arm Description
CPP-ACP with 5%NaF
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Dentinal tubule occlusion
Fully open, partially occluded and fully occluded dentinal tubules. (Percentage %)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04614727
Brief Title
Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish
Official Title
Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish Versus Casein Phosphopeptide Amorphous Calcium Phosphate Containing Fluoride Varnish: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2021 (Anticipated)
Primary Completion Date
May 10, 2021 (Anticipated)
Study Completion Date
June 10, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Samar Saad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity
Keywords
Dentin sensitivity ,nano calcium fluoride, nano fluorapatite,Casein Phosphopeptide Amorphous Calcium Phosphate.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
polymeric nano calcium fluoride containing varnish, NANO SEAL.
Arm Type
Experimental
Arm Title
Casein Phosphopeptide Amorphous Calcium Phosphate Containing Fluoride Varnish,MI varnish
Arm Type
Other
Arm Description
CPP-ACP with 5%NaF
Intervention Type
Combination Product
Intervention Name(s)
polymeric nano calcium fluoride containing varnish NANO SEAL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale VAS
Description
from 0-10 Pain absent: 0 Low pain:(1-3) Moderate pain: (4-6) Intense pain: (7-9) Extremely intense pain: 10.
Time Frame
six months
Title
Schiff air score
Description
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.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Dentinal tubule occlusion
Description
Fully open, partially occluded and fully occluded dentinal tubules. (Percentage %)
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish
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