Dentin HypersensitivityNCT04731766
Effect of Using Different Varnishes on Dentin Hypersensitivity; Na Fluoride and Nano-silver Fluoride
A study testing Citrine 5 % sodium fluoride and concocted nano-silver fluoride in people with Dentin Hypersensitivity, run by Nayera Hassanien Mohamed.
Trial summary
2 different varnishes will be used to test their effectiveness in controlling teeth hypersensitivity in adult patient. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Citrine 5 % sodium fluoride and concocted nano-silver fluoride
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Jan 2022
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients consulting in one of the Qasr Einy, faculty of dentistry outpatient clinics.
- Males or females.
- Patient's age range 25-50 years.
- Patients complaining of hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bi-cuspids, and first molars with exposed cervical dentine) with teeth scoring Bpain (VAS score: greater than or equal to 3) during application of stimulus (airblast and tactile sensitivity test).
- Tooth with exposed root surface, complaining from hypersensitivity (VAS score; greater than or equal to 3).
- Patients accept the 2-months follow-up period.
- Provide informed consent.
Who cannot join
- • Patients participating in another dental study that may alter the results of this study.
- A medical condition that could hinder the accuracy of pain reporting (e.g., pain disorders).
- Any chronic medical condition that requires the regular use of anti-inflammatory pain medications.
- Patients used or applied a desensitizing varnish within the last four weeks.
- Patients with dental problems; chipped teeth, defective restorations, fractured Un-displaced cuspids or deep dental caries.
- Lack of patient's approval and compliance.
About this study
Official title: Effectiveness of Using Nano-Silver Fluoride Varnish Versus Sodium Fluoride Varnish in Management of Cervical Dentin Hypersensitivity in Adult Patients: A Randomized Clinical Trial.
2 different varnishes will be used to test their effectiveness in controlling teeth hypersensitivity in adult patient.
Read the detailed description
In-vivo part:
Each varnish will be applied separately on different teeth according to the manufacturer's instructions and the VAS will be measured according to a specific timeline: T0 (baseline, before application of varnish), T1 (1 week after application), T2 (4 weeks after application) and T3 (4 weeks after application).
In-situ part:
Dentin specimen will be prepared from extracted teeth from the orthodontic department in our college, sterilized and prepared.
it will be bonded to an orthodontic wire and bonded to upper first molar. Dentinal occlusion will be measured using scanning electron microscope following the same timeline.
- Conditions
- Dentin Hypersensitivity
- Being tested
- Citrine 5 % sodium fluoride, concocted nano-silver fluoride
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citrine 5 % sodium fluorideBehavioural
Citrine varnish is a 5% sodium fluoride varnish, It was developed to prolong the contact between the tooth surface and fluoride to increase the resistance against caries attack and manage tooth hypersensitivity; the active ingredient of fluoride varnish is mostly 5% sodium fluoride.
concocted nano-silver fluorideBehavioural
Nano-silver fluoride (NSF) is a solution which has been introduced as an experimental formulation in which it's stability for three years has been proved by Santos et al. The laboratory synthesis of concocted NSF was carried out in a nano-technology center; Several trials were done until we have reached a successful end product.
| Study group | Role | What they receive |
|---|---|---|
| Citrine 5% Sodium Fluoride | Active comparator | It was developed to prolong the contact between the tooth surface and fluoride to increase the resistance against caries attack and manage tooth hypersensitivity; the active ingredient of fluoride varnish is mostly 5% sodium fluoride. Receives: Behavioral: Citrine 5 % sodium fluoride |
| concocuted Nano-silver fluoride | Experimental | Nano-silver fluoride (NSF) is a laboratory synthesized solution Receives: Behavioral: concocted nano-silver fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in dentin Hypersensitivity
Visual Analogue Scale (VAS) will be used; 0 is no pain and 10 is severe pain. Pictures are added to the same, as well as colors to guide the patient during selection of pain severity.
Measured: 1 week, 4 weeks & 8 weeks
Secondary outcomes (1)
change in dentinal Tubule Occlusion
the dentinal tubule occlusion of citrine 5% sodium fluoride and the dentinal tubule occlusion of nano-silver fluoride for treatment of dentin hypersensitivity and compare them together
Measured: 1 week, 4 weeks * 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nayera Hassanien Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nayera Hassanien Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731766
- Sponsor's protocol ID
- 205
- Status last verified
- Jan 2021
- First submitted
- 6 Oct 2020
- Last updated
- 1 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Using Nano-Silver Fluoride Varnish Versus Sodium Fluoride Varnish in Management of Cervical Dentin Hypersensitivity in Adult Patients: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04731766
- Acronym / sponsor ID
- 205
- Conditions
- Dentin Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Nayera Hassanien MohamedUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 1 Feb 2021 (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.
2 different varnishes will be used to test their effectiveness in controlling teeth hypersensitivity in adult patient.
Detailed description
In-vivo part:
Each varnish will be applied separately on different teeth according to the manufacturer's instructions and the VAS will be measured according to a specific timeline: T0 (baseline, before application of varnish), T1 (1 week after application), T2 (4 weeks after application) and T3 (4 weeks after application).
In-situ part:
Dentin specimen will be prepared from extracted teeth from the orthodontic department in our college, sterilized and prepared.
it will be bonded to an orthodontic wire and bonded to upper first molar. Dentinal occlusion will be measured using scanning electron microscope following the same timeline.
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 |
|---|---|---|
| Citrine 5% Sodium Fluoride | Active comparator | Behavioral: Citrine 5 % sodium fluorideIt was developed to prolong the contact between the tooth surface and fluoride to increase the resistance against caries attack and manage tooth hypersensitivity; the active ingredient of fluoride varnish is mostly 5% sodium fluoride. |
| concocuted Nano-silver fluoride | Experimental | Behavioral: concocted nano-silver fluorideNano-silver fluoride (NSF) is a laboratory synthesized solution |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients consulting in one of the Qasr Einy, faculty of dentistry outpatient clinics.
- Males or females.
- Patient's age range 25-50 years.
- Patients complaining of hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bi-cuspids, and first molars with exposed cervical dentine) with teeth scoring Bpain (VAS score: greater than or equal to 3) during application of stimulus (airblast and tactile sensitivity test).
- Tooth with exposed root surface, complaining from hypersensitivity (VAS score; greater than or equal to 3).
Key exclusion criteria (6 listed)
- • Patients participating in another dental study that may alter the results of this study.
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 |
|---|---|---|
| Citrine 5 % sodium fluorideCitrine varnish is a 5% sodium fluoride varnish, It was developed to prolong the contact between the tooth surface and fluoride to increase the resistance against caries attack and manage tooth hypersensitivity; the active ingredient of fluoride varnish is mostly 5% sodium fluoride. | Behavioural | Citrine 5% Sodium Fluoride |
| concocted nano-silver fluorideNano-silver fluoride (NSF) is a solution which has been introduced as an experimental formulation in which it's stability for three years has been proved by Santos et al. The laboratory synthesis of concocted NSF was carried out in a nano-technology center; Several trials were done until we have reached a successful end product. | Behavioural | concocuted Nano-silver fluoride |
Primary outcome
change in dentin Hypersensitivity
Time frame: 1 week, 4 weeks & 8 weeks
Visual Analogue Scale (VAS) will be used; 0 is no pain and 10 is severe pain. Pictures are added to the same, as well as colors to guide the patient during selection of pain severity.
1 secondary outcome
change in dentinal Tubule Occlusion
Time frame: 1 week, 4 weeks * 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: No
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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 Citrine 5 % sodium fluoride and concocted nano-silver fluoride in people with Dentin Hypersensitivity, run by Nayera Hassanien Mohamed.
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 7 inclusion and 6 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 1 Feb 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?
change in dentin Hypersensitivity (time frame: 1 week, 4 weeks & 8 weeks). 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 1 Feb 2021.