Dentin HypersensitivityPhase 1NCT06025084
The Effect of the Egg Shell Nanoparticles Combined With Titanium Dioxide Nanoparticles
A Phase 1 study testing Egg Shell nanoparticles in people with Dentin Hypersensitivity, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Dentin hypersensitivity is one of the most commonly occurring clinical dental conditions which is characterized by short and sharp pain which arises from exposed dentin in response to external stimuli, which typically are thermal, evaporative, tactile, osmotic or chemical. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Egg Shell nanoparticles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 30 Mar 2023
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1- For patients;
- Age between 20 and 55 years
- Patients in good systemic health with clinically elicitable dentin hypersensitivity
- Absence of contraindications to the proposed therapies as allergy. 2 - For teeth;
- Absence of local pathologies (e.g., caries and fractures)
- Visual analog scale (VAS) score ≥3
Who cannot join
- -- For patients;
- Use of any desensitizing toothpaste for previous 3 or 4 months.
- Taking analgesics/anti-inflammatory drugs at the time of the study, pregnancy, and smoking.
- 2 -For teeth ;
- Teeth with abrasion and attrition.
- Carious lesions on the selected or neighboring teeth, defective restorations
- Any professional desensitizing therapy on the selected teeth during the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Egg Shell Nanoparticles Combined With Titanium Dioxide Nanoparticles on The Permeability of Dentinal Tubules After Exposure to Wear Challenges and Their Clinical Efficacy in The Treatment of Dentin Hypersensitivity
Dentin hypersensitivity is one of the most commonly occurring clinical dental conditions which is characterized by short and sharp pain which arises from exposed dentin in response to external stimuli, which typically are thermal, evaporative, tactile, osmotic or chemical.
Hypersensitive dentin is mostly found in buccal tooth areas, in which enamel is missing because of abrasion, attrition, or erosion. The most generally accepted theory regarding the mechanism of dentin hypersensitivity is the hydrodynamic theory. It proposes that a pain-provoking stimulus increases the flow of the dentinal tubular fluid and consequently, stimulates the nerves around the odontoblasts, leading to dentin hypersensitivity.
Read the detailed description
Dentin desensitizing products, containing agents such as fluoride, strontium salts, oxalate, glutaraldehyde and bioactive glass, are employed to treat dentin hypersensitivity.
Based on the hydrodynamic theory, there are two main strategies for the treatment of dentin hypersensitivity as: (1) occluding the dentinal tubules to reduce the fluid flow, and (2) decreasing the excitability of the intradental nerve.
Although these products and agents were reported to be effective, short durability and poor effectiveness were often exhibited. The therapeutic effects of these desensitizing products were short lived on account of daily tooth brushing or drinking of acidic beverages and the occlusion effects were sometimes incomplete. Owing to these drawbacks, the use of nanomaterials as dentin occluding material has been predicted to be the future of treating DH.
Amorphous Calcium Phosphate (ACP) has the potential to remineralize the structure of tooth. ACP is a soluble calcium phosphate compound that discharges calcium and phosphate ions to change to apatite and remineralize the tooth structure when it comes in contact with saliva. Forming on the enamel and within the dental tubules, ACP provides a reservoir of phosphate and calcium ions in the saliva Casein phospho-peptide (CPP) is a milk-derived protein that joins to the tooth's biofilm and is applied to stabilize ACP. In recent years, remineralization products used CPP as a vehicle to deliver and preserve a super saturation state of ACP near the surface of tooth. A previous study showed that the application of (CPP-ACP) containing agents as GC tooth mousse and MI paste plus can reduce dentin permeability by occluding dentin tubules. It revealed that these materials can be effective for treatment of dentin hypersensitivity.
Recently, there has been a renewed interest in developing materials with a bioactive potential that could block the exposed dentinal tubules and subsequently reduce the fluid flow within the tubules. Eggshells (EBs) have been investigated in recent years for their remineralization capabilities. EB has rich bioavailable calcium content in the form of carbonates and oxides. It contains 94% calcium carbonate, 1% calcium phosphate, 1% magnesium carbonate, and 4% organic matter. In addition, eggshell provides a cost-effective, renewable, and sustainable source of material for EnHAp. A previous study revealed that eggshell powder is predicted to be the future of tooth remineralization and highly effective in occluding dentinal tubules and reducing dentin hypersensitivity.
Titanium dioxide is one of the few materials that classified as bioactive meaning that it enhances bone growth and stable bone bonding with dental implants via precipitation of hydroxyapatite on its surface
- Conditions
- Dentin Hypersensitivity
- Being tested
- Egg Shell nanoparticles
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg Shell nanoparticlesDrug
Also called Titanium dioxide nanoparticles
Evaluate the effects of egg shell nanoparticles combined with Titanium dioxide nanoparticles in the treatment of dentin hypersensitivity at different time intervals.
| Study group | Role | What they receive |
|---|---|---|
| first group (A1) | Active comparator | About 24 patients hypersensitive teeth. So the hypersensitive teeth will be treated with egg shell nanoparticles Receives: Drug: Egg Shell nanoparticles |
| second group (A2) | Active comparator | About 24 patients hypersensitive teeth. treated with the combination therapy of eggshell and TiO2. Receives: Drug: Egg Shell nanoparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of dentin hypersensitivity
The pain response will be assessed using the numerical Visual Analogue Scale (VAS, range 0-10), with 0 indicating 'no pain' and 10 indicating 'intolerably severe pain.
Measured: from baseline to 2 months after the treatment day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Dec 2022
- Primary completion15 Mar 2023
- Study completion30 Mar 2023
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fatma Hussein, Lecturer, Principal investigator, Al-Azhar Faculty of Dentistary for girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025084
- Sponsor's protocol ID
- Fadia Ali El-Sayed Shosha
- Status last verified
- Aug 2023
- First submitted
- 29 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Egg Shell Nanoparticles Combined With Titanium Dioxide Nanoparticles on The Permeability of Dentinal Tubules After Exposure to Wear Challenges and Their Clinical Efficacy in The Treatment of Dentin Hypersensitivity
- ClinicalTrials.gov ID
- NCT06025084
- Acronym / sponsor ID
- Fadia Ali El-Sayed Shosha
- Conditions
- Dentin Hypersensitivity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 6 Sep 2023 (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.
Dentin hypersensitivity is one of the most commonly occurring clinical dental conditions which is characterized by short and sharp pain which arises from exposed dentin in response to external stimuli, which typically are thermal, evaporative, tactile, osmotic or chemical.
Hypersensitive dentin is mostly found in buccal tooth areas, in which enamel is missing because of abrasion, attrition, or erosion. The most generally accepted theory regarding the mechanism of dentin hypersensitivity is the hydrodynamic theory. It proposes that a pain-provoking stimulus increases the flow of the dentinal tubular fluid and consequently, stimulates the nerves around the odontoblasts, leading to dentin hypersensitivity.
Detailed description
Dentin desensitizing products, containing agents such as fluoride, strontium salts, oxalate, glutaraldehyde and bioactive glass, are employed to treat dentin hypersensitivity.
Based on the hydrodynamic theory, there are two main strategies for the treatment of dentin hypersensitivity as: (1) occluding the dentinal tubules to reduce the fluid flow, and (2) decreasing the excitability of the intradental nerve.
Although these products and agents were reported to be effective, short durability and poor effectiveness were often exhibited. The therapeutic effects of these desensitizing products were short lived on account of daily tooth brushing or drinking of acidic beverages and the occlusion effects were sometimes incomplete. Owing to these drawbacks, the use of nanomaterials as dentin occluding material has been predicted to be the future of treating DH.
Amorphous Calcium Phosphate (ACP) has the potential to remineralize the structure of tooth. ACP is a soluble calcium phosphate compound that discharges calcium and phosphate ions to change to apatite and remineralize the tooth structure when it comes in contact with saliva. Forming on the enamel and within the dental tubules, ACP provides a reservoir of phosphate and calcium ions in the saliva Casein phospho-peptide (CPP) is a milk-derived protein that joins to the tooth's biofilm and is applied to stabilize ACP. In recent years, remineralization products used CPP as a vehicle to deliver and preserve a super saturation state of ACP near the surface of tooth. A previous study showed that the application of (CPP-ACP) containing agents as GC tooth mousse and MI paste plus can reduce dentin permeability by occluding dentin tubules. It revealed that these materials can be effective for treatment of dentin hypersensitivity.
Recently, there has been a renewed interest in developing materials with a bioactive potential that could block the exposed dentinal tubules and subsequently reduce the fluid flow within the tubules. Eggshells (EBs) have been investigated in recent years for their remineralization capabilities. EB has rich bioavailable calcium content in the form of carbonates and oxides. It contains 94% calcium carbonate, 1% calcium phosphate, 1% magnesium carbonate, and 4% organic matter. In addition, eggshell provides a cost-effective, renewable, and sustainable source of material for EnHAp. A previous study revealed that eggshell powder is predicted to be the future of tooth remineralization and highly effective in occluding dentinal tubules and reducing dentin hypersensitivity.
Titanium dioxide is one of the few materials that classified as bioactive meaning that it enhances bone growth and stable bone bonding with dental implants via precipitation of hydroxyapatite on its surface
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first group (A1) | Active comparator | Drug: Egg Shell nanoparticlesAbout 24 patients hypersensitive teeth. So the hypersensitive teeth will be treated with egg shell nanoparticles |
| second group (A2) | Active comparator | Drug: Egg Shell nanoparticlesAbout 24 patients hypersensitive teeth. treated with the combination therapy of eggshell and TiO2. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 1- For patients;
- Age between 20 and 55 years
- Patients in good systemic health with clinically elicitable dentin hypersensitivity
- Absence of contraindications to the proposed therapies as allergy. 2 - For teeth;
- Absence of local pathologies (e.g., caries and fractures)
Key exclusion criteria (7 listed)
- -- For patients;
- 2 -For teeth ;
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 |
|---|---|---|
| Egg Shell nanoparticlesAlso: Titanium dioxide nanoparticlesEvaluate the effects of egg shell nanoparticles combined with Titanium dioxide nanoparticles in the treatment of dentin hypersensitivity at different time intervals. | Drug | first group (A1), second group (A2) |
Primary outcome
Assessment of dentin hypersensitivity
Time frame: from baseline to 2 months after the treatment day.
The pain response will be assessed using the numerical Visual Analogue Scale (VAS, range 0-10), with 0 indicating 'no pain' and 10 indicating 'intolerably severe pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
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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.
Fatma Hussein, Lecturer principal investigator
Al-Azhar Faculty of Dentistary for girls
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Egg Shell nanoparticles in people with Dentin Hypersensitivity, run by Egymedicalpedia 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 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: finished, as of the sponsor's last update on 6 Sep 2023. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of dentin hypersensitivity (time frame: from baseline to 2 months after the treatment day.). 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 6 Sep 2023.