Dentin HypersensitivityNCT04614727
Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish
A study testing polymeric nano calcium fluoride containing varnish NANO SEAL in people with Dentin Hypersensitivity, run by Samar Saad.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- polymeric nano calcium fluoride containing varnish NANO SEAL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2021to 10 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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
- Being tested
- polymeric nano calcium fluoride containing varnish NANO SEAL
- Keywords
- Dentin sensitivity ,nano calcium fluoride, nano fluorapatite,Casein Phosphopeptide Amorphous Calcium Phosphate.
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| polymeric nano calcium fluoride containing varnish, NANO SEAL. | Experimental | Not described Receives: 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 Receives: Combination Product: polymeric nano calcium fluoride containing varnish NANO SEAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months
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.
Measured: six months
Secondary outcomes (1)
Dentinal tubule occlusion
Fully open, partially occluded and fully occluded dentinal tubules. (Percentage %)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start10 Feb 2021 (estimated)
- Primary completion10 May 2021 (estimated)
- Study completion10 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samar Saad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samar Saad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614727
- Sponsor's protocol ID
- Polymeric Nano Calcium Fluorid
- Status last verified
- Jan 2021
- First submitted
- 23 Oct 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish Versus Casein Phosphopeptide Amorphous Calcium Phosphate Containing Fluoride Varnish: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04614727
- Acronym / sponsor ID
- Polymeric Nano Calcium Fluorid
- Conditions
- Dentin Hypersensitivity
- Keywords
- Dentin sensitivity ,nano calcium fluoride, nano fluorapatite,Casein Phosphopeptide Amorphous Calcium Phosphate.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Samar SaadUniversity, hospital or other
- Study start
- 10 Feb 2021 (estimated)
- Primary completion
- 10 May 2021 (estimated)
- Study completion
- 10 Jun 2021 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Combination Product: polymeric nano calcium fluoride containing varnish NANO SEALCPP-ACP with 5%NaF |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polymeric nano calcium fluoride containing varnish NANO SEALIt 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. | Combination product | Casein Phosphopeptide Amorphous Calcium Phosphate Containing Fluoride Varnish,MI varnish, polymeric nano calcium fluoride containing varnish, NANO SEAL. |
Primary outcome
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.
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.
1 secondary outcome
Dentinal tubule occlusion
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing polymeric nano calcium fluoride containing varnish NANO SEAL in people with Dentin Hypersensitivity, run by Samar Saad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale VAS (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.