Dentin HypersensitivityS-PRGNCT06276777
The Effect of Using Desensitizers Containing S-PRG In Treatment Of Dentin Hypersensitivity Over 6 Months: A Randomized Clinical Trial
A study testing Tooth varnish (PRG Barrier Coat from Shofu) and Tooth varnish (Clinpro white varnish 3M) in people with Dentin Hypersensitivity, run by Eman Omar Elfarouk at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the effect of desensitizer containing S-PRG have similar effect as sodium fluoride with functionalized tri-calcium phosphate containing desensitizer in relieving dentinal hypersensitivity in adult patients for six months follow-up. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Tooth varnish (PRG Barrier Coat from Shofu) and Tooth varnish (Clinpro white varnish 3M)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 Dec 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good oral hygiene.
- Cooperative patients who show interest to participate in the study and welling to sign the informed consent.
- Healthy patients with no history of previous systematic diseases that can affect their oral health.
- Normal and healthy gingival tissue.
- Teeth that have no cavitation or restorations.
- Patients with at least 20 natural permanent teeth and at least two teeth with a VAS score from 4 to 10.
- Anterior teeth.
Who cannot join
- Allergic to the ingredients used in the study.
- Gastrointestinal disorders (They have repeated vomiting attacks).
- Medically compromised (They cannot tolerate the procedures).
- Taking desensitizing treatment in the last 6 months (It affects the outcome).
- Taking anti-inflammatory drugs (It affects the hypersensitivity perception).
- Pregnant females (They complain from nausea and repeated vomiting attacks)
- Smokers (Smoking will affect the oral hygiene and periodontal health).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry Cairo University
Cairo, 11331
Eman Omar, bachelor, 01156677558, eman.omar@dentistry.cu.edu.eg
About this study
Official title: The Effect of Using Desensitizers Containing S-PRG Versus Sodium Fluoride With Functionalized Tri-Calcium Phosphate In Treatment Of Dentin Hypersensitivity In Adult Patients Over 6 Months: A Randomized Clinical Trial
The goal of this clinical trial is to compare the effect of desensitizer containing S-PRG have similar effect as sodium fluoride with functionalized tri-calcium phosphate containing desensitizer in relieving dentinal hypersensitivity in adult patients for six months follow-up. patients will be asked to report pain degree on the visual analogue scale (VAS) along the follow up periods on both groups.
- Conditions
- Dentin Hypersensitivity
- Being tested
- Tooth varnish (PRG Barrier Coat from Shofu), Tooth varnish (Clinpro white varnish 3M)
- Keywords
- S-PRG
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth varnish (PRG Barrier Coat from Shofu)Procedure or surgery
Treatment of cervical dentin hypersensitivity with tooth desensitizers.
Tooth varnish (Clinpro white varnish 3M)Procedure or surgery
Treatment of cervical dentin hypersensitivity with tooth desensitizers.
| Study group | Role | What they receive |
|---|---|---|
| Varnish contains S-PRG (PRG Barrier Coat from Shofu) | Experimental | Treatment of dentin hypersensitivity by application of tooth varnish containing S-PRG. Receives: Procedure: Tooth varnish (PRG Barrier Coat from Shofu) |
| Varnish contains sodium fluoride and functionalized tri-calcium phosphate(Clinpro white varnish 3M) | Active comparator | Treatment of dentin hypersensitivity by application of tooth varnish containing sodium fluoride with functionalized tri-calcium phosphate. Receives: Procedure: Tooth varnish (Clinpro white varnish 3M) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentin hypersensitivity reduction
The participants will point out the degree of sensitivity on the VAS scale (0-10) chart.
Measured: assessment will be done immediately after the treatment then after 1 week, 4 weeks, 3 months and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eman Omar Elfarouk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eman Omar Elfarouk, Cairo University
- Investigators
- Eman Omar, bachelor, Principal investigator, Cairo University faculty of oral and dental medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276777
- Sponsor's protocol ID
- SPRG Dentin Hypersensitivity
- Acronym
- S-PRG
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Desensitizers Containing S-PRG Versus Sodium Fluoride With Functionalized Tri-Calcium Phosphate In Treatment Of Dentin Hypersensitivity In Adult Patients Over 6 Months: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06276777
- Acronym / sponsor ID
- S-PRG / SPRG Dentin Hypersensitivity
- Conditions
- Dentin Hypersensitivity
- Keywords
- S-PRG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Eman Omar ElfaroukUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 26 Feb 2024 (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 goal of this clinical trial is to compare the effect of desensitizer containing S-PRG have similar effect as sodium fluoride with functionalized tri-calcium phosphate containing desensitizer in relieving dentinal hypersensitivity in adult patients for six months follow-up. patients will be asked to report pain degree on the visual analogue scale (VAS) along the follow up periods on both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varnish contains S-PRG (PRG Barrier Coat from Shofu) | Experimental | Procedure: Tooth varnish (PRG Barrier Coat from Shofu)Treatment of dentin hypersensitivity by application of tooth varnish containing S-PRG. |
| Varnish contains sodium fluoride and functionalized tri-calcium phosphate(Clinpro white varnish 3M) | Active comparator | Procedure: Tooth varnish (Clinpro white varnish 3M)Treatment of dentin hypersensitivity by application of tooth varnish containing sodium fluoride with functionalized tri-calcium phosphate. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Good oral hygiene.
- Cooperative patients who show interest to participate in the study and welling to sign the informed consent.
- Healthy patients with no history of previous systematic diseases that can affect their oral health.
- Normal and healthy gingival tissue.
- Teeth that have no cavitation or restorations.
Key exclusion criteria (7 listed)
- Allergic to the ingredients used in the study.
- Gastrointestinal disorders (They have repeated vomiting attacks).
- Medically compromised (They cannot tolerate the procedures).
- Taking desensitizing treatment in the last 6 months (It affects the outcome).
- Taking anti-inflammatory drugs (It affects the hypersensitivity perception).
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 |
|---|---|---|
| Tooth varnish (PRG Barrier Coat from Shofu)Treatment of cervical dentin hypersensitivity with tooth desensitizers. | Procedure or surgery | Varnish contains S-PRG (PRG Barrier Coat from Shofu) |
| Tooth varnish (Clinpro white varnish 3M)Treatment of cervical dentin hypersensitivity with tooth desensitizers. | Procedure or surgery | Varnish contains sodium fluoride and functionalized tri-calcium phosphate(Clinpro white varnish 3M) |
Primary outcome
Dentin hypersensitivity reduction
Time frame: assessment will be done immediately after the treatment then after 1 week, 4 weeks, 3 months and 6 months.
The participants will point out the degree of sensitivity on the VAS scale (0-10) chart.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- 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.
Eman Omar, bachelor principal investigator
Cairo University faculty of oral and dental medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth varnish (PRG Barrier Coat from Shofu) and Tooth varnish (Clinpro white varnish 3M) in people with Dentin Hypersensitivity, run by Eman Omar Elfarouk at 1 site in Egypt.
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 7 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 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Eman Omar El-farouk, masters (01156677558, eman.omar@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentin hypersensitivity reduction (time frame: assessment will be done immediately after the treatment then after 1 week, 4 weeks, 3 months and 6 months.). 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 Feb 2024.