Dentin HypersensitivityPhase 1NCT06493500
Efficacy of Formulated Eggshell Derived Nano-hydroxyapatite Containing Toothpaste With and Without Addition of Fluoride vs. Conventional Desensitizing Fluoride Containing Toothpaste in Management of Dentin Hypersensitivity
A Phase 1 study testing Eggshell derived Nano-hydroxyapatite (n-HAp) with a Fluoride containing toothpaste and Eggshell derived Nano-hydroxyapatite (n-HAp) without a Fluoride containing toothpaste in people with Dentin Hypersensitivity and Fluoride, run by Cairo University.
Trial summary
compare the effectiveness of Eggshell derived nano-Hydroxyapatite with and without fluoride and conventional fluoride containing tooth paste versus conventional desensitizing fluoride containing tooth paste on dentinal tubule occlusion and dentin mineral deposition. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity, Fluoride, Nano-hydroxy Apatite
- What is being tested?
- Eggshell derived Nano-hydroxyapatite (n-HAp) with a Fluoride containing toothpaste and Eggshell derived Nano-hydroxyapatite (n-HAp) without a Fluoride containing toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Mar 2025
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult Patients Aged 18-60
- Males or females.
- Good oral hygiene
- Absence of abnormal occlusion habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).
- Teeth with hypersensitivity, VAS ≥5
- Co-operative patients who show interest to participate in the study.
Who cannot join
- Patients with known allergic or adverse reaction to the tested materials.
- Systematic disease that may affect participation.
- Xerostomic patients.
- Patients with bad oral hygiene
- Patients with orthodontic appliances, or bridge work that might interfere with evaluation
- Patients who did any periodontal surgeries within the previous 6 months.
- Patients with physical disabilities
About this study
Official title: Efficacy of Nano-hydroxyapatite Containing Tooth Paste on Dentin Hypersensitivity of Adult Patient
compare the effectiveness of Eggshell derived nano-Hydroxyapatite with and without fluoride and conventional fluoride containing tooth paste versus conventional desensitizing fluoride containing tooth paste on dentinal tubule occlusion and dentin mineral deposition.
Read the detailed description
Recently advanced nanotechnology has taken a wide leap in improving the various measures in the treatment of hypersensitivity by its nanoparticles. Nanoparticles can easily penetrate into dentin tubules, which could act as mineralizing agents that block fluid movement within the dentin tubules when combined with various agents.
Hydroxyapatite (HAp) is the major inorganic component of natural teeth and bone. Nano-sized particles of hydroxyapatite are similar to the apatite crystals of tooth enamel in morphology and crystal structure and has been studied as a biomimetic material for the reconstruction of tooth enamel suffering from mineral loss because of its unique potential for remineralization. Nano-hydroxyapatite (n-HAp) was considered a promising active ingredient used for the treatment of DH due to high biocompatibility and bioactivity. In toothpastes, HAp was included in the form of nanocrystals because they dissolve easier in this form. Crystals of n-HAp included in dental products have a dimension of 50-1000 nm, which enables them to act like fillers. These products can penetrate and block the exposed dentinal tubules which are responsible for DH
- Conditions
- Dentin Hypersensitivity, Fluoride, Nano-hydroxy Apatite
- Being tested
- Eggshell derived Nano-hydroxyapatite (n-HAp) with a Fluoride containing toothpaste, Eggshell derived Nano-hydroxyapatite (n-HAp) without a Fluoride containing toothpaste
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eggshell derived Nano-hydroxyapatite (n-HAp) with a Fluoride containing toothpasteDrug
Also called (n-HAp) toothpaste
patients would be instructed to treat their teeth for 5 min twice a day with the provided toothpaste.
Eggshell derived Nano-hydroxyapatite (n-HAp) without a Fluoride containing toothpasteDrug
Also called nano-hydroxyapatite with flouride
patients would be instructed to treat their teeth for 5 min twice a day with the provided toothpaste.
| Study group | Role | What they receive |
|---|---|---|
| Eggshell derived Nano-hydroxyapatite (n-HAp) with Fluoride containing toothpaste | Experimental | patients would be instructed to treat their teeth for 5 min twice a day with the provided toothpaste. Receives: Drug: Eggshell derived Nano-hydroxyapatite (n-HAp) with a Fluoride containing toothpaste |
| Eggshell derived Nano-hydroxyapatite (n-HAp) without Fluoride containing toothpaste | Experimental | patients would be instructed totreat their teeth for 5 min twice a day with the provided toothpaste. Receives: Drug: Eggshell derived Nano-hydroxyapatite (n-HAp) without a Fluoride containing toothpaste |
| Commercially available Fluoride containing toothpaste (Sensodyne Rapid Relief) | Active comparator | patients would be instructed totreat their teeth for 5 min twice a day with the provided toothpaste. Receives: Drug: Eggshell derived Nano-hydroxyapatite (n-HAp) with a Fluoride containing toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity due to Dentin Hypersensitivity by Visual Analogue Scale (VAS)
VAS is used to "quantify" the pain severity in millimeter (mm) in response to such query as "Draw a line on the scale that shows how much pain you have at this time " with "no pain" on the far left end of scale at 0 mm and "pain as bad as it can be" on the far right at 100 mm.
Measured: T (Time): T0= Baseline (before treatment). T1= 7 days. T2= 3 months. T3= 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shahenda gamal tawfik hamdy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493500
- Sponsor's protocol ID
- cebc-cu-2024-06-30
- Status last verified
- Jul 2024
- First submitted
- 30 Jun 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nano-hydroxyapatite Containing Tooth Paste on Dentin Hypersensitivity of Adult Patient
- ClinicalTrials.gov ID
- NCT06493500
- Acronym / sponsor ID
- cebc-cu-2024-06-30
- Conditions
- Dentin Hypersensitivity, Fluoride, Nano-hydroxy Apatite
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 10 Jul 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.
compare the effectiveness of Eggshell derived nano-Hydroxyapatite with and without fluoride and conventional fluoride containing tooth paste versus conventional desensitizing fluoride containing tooth paste on dentinal tubule occlusion and dentin mineral deposition.
Detailed description
Recently advanced nanotechnology has taken a wide leap in improving the various measures in the treatment of hypersensitivity by its nanoparticles. Nanoparticles can easily penetrate into dentin tubules, which could act as mineralizing agents that block fluid movement within the dentin tubules when combined with various agents.
Hydroxyapatite (HAp) is the major inorganic component of natural teeth and bone. Nano-sized particles of hydroxyapatite are similar to the apatite crystals of tooth enamel in morphology and crystal structure and has been studied as a biomimetic material for the reconstruction of tooth enamel suffering from mineral loss because of its unique potential for remineralization. Nano-hydroxyapatite (n-HAp) was considered a promising active ingredient used for the treatment of DH due to high biocompatibility and bioactivity. In toothpastes, HAp was included in the form of nanocrystals because they dissolve easier in this form. Crystals of n-HAp included in dental products have a dimension of 50-1000 nm, which enables them to act like fillers. These products can penetrate and block the exposed dentinal tubules which are responsible for DH
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eggshell derived Nano-hydroxyapatite (n-HAp) with Fluoride containing toothpaste | Experimental | Drug: Eggshell derived Nano-hydroxyapatite (n-HAp) with a Fluoride containing toothpastepatients would be instructed to treat their teeth for 5 min twice a day with the provided toothpaste. |
| Eggshell derived Nano-hydroxyapatite (n-HAp) without Fluoride containing toothpaste | Experimental | Drug: Eggshell derived Nano-hydroxyapatite (n-HAp) without a Fluoride containing toothpastepatients would be instructed totreat their teeth for 5 min twice a day with the provided toothpaste. |
| Commercially available Fluoride containing toothpaste (Sensodyne Rapid Relief) | Active comparator | Drug: Eggshell derived Nano-hydroxyapatite (n-HAp) with a Fluoride containing toothpastepatients would be instructed totreat their teeth for 5 min twice a day with the provided toothpaste. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult Patients Aged 18-60
- Males or females.
- Good oral hygiene
- Absence of abnormal occlusion habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).
- Teeth with hypersensitivity, VAS ≥5
Key exclusion criteria (7 listed)
- Patients with known allergic or adverse reaction to the tested materials.
- Systematic disease that may affect participation.
- Xerostomic patients.
- Patients with bad oral hygiene
- Patients with orthodontic appliances, or bridge work that might interfere with evaluation
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 |
|---|---|---|
| Eggshell derived Nano-hydroxyapatite (n-HAp) with a Fluoride containing toothpasteAlso: (n-HAp) toothpastepatients would be instructed to treat their teeth for 5 min twice a day with the provided toothpaste. | Drug | Commercially available Fluoride containing toothpaste (Sensodyne Rapid Relief), Eggshell derived Nano-hydroxyapatite (n-HAp) with Fluoride containing toothpaste |
| Eggshell derived Nano-hydroxyapatite (n-HAp) without a Fluoride containing toothpasteAlso: nano-hydroxyapatite with flouridepatients would be instructed to treat their teeth for 5 min twice a day with the provided toothpaste. | Drug | Eggshell derived Nano-hydroxyapatite (n-HAp) without Fluoride containing toothpaste |
Primary outcome
Pain intensity due to Dentin Hypersensitivity by Visual Analogue Scale (VAS)
Time frame: T (Time): T0= Baseline (before treatment). T1= 7 days. T2= 3 months. T3= 6 months
VAS is used to "quantify" the pain severity in millimeter (mm) in response to such query as "Draw a line on the scale that shows how much pain you have at this time " with "no pain" on the far left end of scale at 0 mm and "pain as bad as it can be" on the far right at 100 mm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
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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 Phase 1 study testing Eggshell derived Nano-hydroxyapatite (n-HAp) with a Fluoride containing toothpaste and Eggshell derived Nano-hydroxyapatite (n-HAp) without a Fluoride containing toothpaste in people with Dentin Hypersensitivity and Fluoride, run by Cairo University.
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 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 10 Jul 2024. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain intensity due to Dentin Hypersensitivity by Visual Analogue Scale (VAS) (time frame: T (Time): T0= Baseline (before treatment). T1= 7 days. T2= 3 months. T3= 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 10 Jul 2024.