Dentin HypersensitivityNCT06557980
Effectiveness of Calcium Silicate and Sodium Fluoride Nanoparticles in The Management of Dentin Hypersensitivity
A study testing toothpaste in people with Dentin Hypersensitivity, run by Minia University.
Trial summary
This study will be performed to assess the effect of inert prepared tooth paste loaded with Calcium Silicate Nanoparticles (CSNPs) and compare it to another one containing Sodium Fluoride Nanoparticles in the management of patients complaining of hypersensitivity and laboratory investigating the efficacy of CSNPs and… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bicuspids, and first molars with exposed cervical dentine)
- Areas with hard tissue erosion
- cuneiform defect, pathological abrasion.
- Gingival recession
- Good overall physical health
- Age between 20 to 40 years; and provision of written informed consent
Who cannot join
- chipped teeth
- Defective restorations
- fractured un displaced cuspids
- deep dental caries
- deep periodontal pockets
- orthodontic appliances, dentures, or bridgework that would interfere with the evaluation of hypersensitivity.
Show all 9Show fewer
- periodontal surgery within the previous 6 months.
- ongoing treatment with antibiotics and/or anti-inflammatory and/or analgesic drugs.
- ongoing treatment for tooth hypersensitivity, pregnancy, or lactation; heavy smoking and alcohol or drug abuse.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Calcium Silicate and Sodium Fluoride Nanoparticles in The Management of Dentin Hypersensitivity (Randomized Controlled Clinical Trial and In-Vitro Study)
This study will be performed to assess the effect of inert prepared tooth paste loaded with Calcium Silicate Nanoparticles (CSNPs) and compare it to another one containing Sodium Fluoride Nanoparticles in the management of patients complaining of hypersensitivity and laboratory investigating the efficacy of CSNPs and NaFl Nps containing toothpaste in dentinal tubules occlusion.
Read the detailed description
Hypersensitivity has been defined as the pain arising from exposed dentin, typically in response to chemical, thermal, tactile or osmotic stimuli that cannot be explained as arising from any other form of dental defect or pathology. The pain of dentin hypersensitivity is classically, short, sharp, of rapid onset in character and of the duration of the applied stimuli. hypersensitivity was first documented by Blum. Although much has been learnt about hypersensitivity overtime, yet the mechanism of pain was explained by several hypotheses welling to be aware about the nature of the Disease firstly was the hypothesis that dentin was innervated and therefore, nerves were directly triggered by the stimulus. A further theory, termed the odontoblast transducer mechanism. Currently, the most widely accepted theory is the hydrodynamic theory which determined that there was an outward flow of fluid along the dentinal tubules.
In addition to extrapolation of the pain mechanism, allocating the etiology and the risk factors have a crucial impact on the disease outcome as well as the line of treatment. For hypersensitivity to occur lesion localization, where the dentin surface of a tooth must be exposed. And a lesion initiation must take place where the number of dentin tubules in close proximity to each other must be patent from the pulp to the oral environment.
Several in vitro and in situ data, case report data and epidemiological surveys summarized the most common etiologic and risk factors in the two main causes: gingival recession exposing dentin, either by periodontal Disease, zealous brushing, smoking and loss of hard tissue exposing dentin, also by frank carious lesions with dentin exposure of smooth tooth surface or development of non-carious cervical lesions.
Eventually based on the great knowledge about hypersensitivity nature, Etiologic and risk factors the dental professionals can now select the appropriate line of treatment either with conservative non-surgical intervention ex; Elimination of etiological factors, addition of desensitizers to toothpastes like Potassium nitrate, Strontium, Arginine and Calcium Carbonate, Calcium Sodium Phosphosilicate. Use of Dentin desensitizing products which have different ingredients, such as fluoride, hydroxyethyl methacrylate, glutaraldehyde, oxalate and potassium nitrate, as well as a combination of these ingredients.
Several in vitro, in situ as well as in vivo studies tackled the immense remineralizing capabilities of calcium silicate and it's in vitro promising results in formation of hydroxyapatite on enamel as well as occluding dentinal tubules thus giving potential anti-hypersensitivity benefits. However in vivo anti-hypersensitivity benefits were not tackled enough in literature.
This study will be performed to clinically assess the effect of toothpaste loaded with calcium silicate Nanoparticles (CS NPs) and compare it to one loaded with Sodium fluoride Nanoparticles (NaFL NPs) in the management of dentin hypersensitivity and laboratory investigating their efficacy in dentinal tubules occlusion. The null Hypothesis is the CS NPs has the same effect as Na FLNPs in the management of hypersensitivity complaining patient. The alternative hypothesis is the dentinal tubules occlusion by CSNPs will be like that one produced by Na FLNPs.
- Conditions
- Dentin Hypersensitivity
- Being tested
- 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.
toothpasteOther
group of patients with hypersensitive areas will use the calcium silicate toothpaste twice per day (morning and bedtime) the toothpaste will be applied uniformly using medium toothbrush to the hypersensitive surfaces for 30seconds. After that, the patient will rinse their mouth with plain water. the other group of patients will use the sodium fluoride toothpaste twice per day (morning and bedtime). The toothpaste will be applied uniformly using a medium toothbrush to the hypersensitive areas for 30 seconds after that the patients will rinse their mouth with plain water
| Study group | Role | What they receive |
|---|---|---|
| Toothpaste containing calcium silicate nanoparticles | Active comparator | patients with hypersensitive areas will use the calcium silicate based toothpaste Receives: Other: toothpaste |
| Toothpaste containing sodium fluoride nanoparticles | Active comparator | patients with hypersensitive areas will use the sodium fluoride based toothpaste Receives: Other: toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Visual analogue scale
The Visual analogue scale on a scale (0 = no pain,10 = extreme pain).
Measured: one year
The Verbal rating scale
The Verbal rating scale from to: (0 = no discomfort, 1=mild discomfort,2 = significant discomfort,3= significant discomfort lasting more than 10 seconds)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study startMay 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 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 Minia 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each toothpaste will be applied uniformly twice per day (morning and bed time) to the hypersensitive surfaces for30 seconds. After that, the patient will rinse their mouth with plain water. Responses to the various stimuli will be evaluated using the same tactile and thermal stimuli used previously, and scores will be recorded 1day1,2 ,4 ,8 ,12 , weeks then 6 and 12 months after their application, respectively. Furthermore, the patients will be advised to report to the operator any unanticipated pain seizures, erroneous usage as well as the number of applications of a specific desensitizing agent required to elicit a positive response will also be recorded. The results will be statistically analyzed after 8 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Abd El Hamid Lotfy, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557980
- Sponsor's protocol ID
- hypersensitivity management
- Status last verified
- May 2025
- First submitted
- 7 Aug 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Calcium Silicate and Sodium Fluoride Nanoparticles in The Management of Dentin Hypersensitivity (Randomized Controlled Clinical Trial and In-Vitro Study)
- ClinicalTrials.gov ID
- NCT06557980
- Acronym / sponsor ID
- hypersensitivity management
- Conditions
- Dentin Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 16 Aug 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.
This study will be performed to assess the effect of inert prepared tooth paste loaded with Calcium Silicate Nanoparticles (CSNPs) and compare it to another one containing Sodium Fluoride Nanoparticles in the management of patients complaining of hypersensitivity and laboratory investigating the efficacy of CSNPs and NaFl Nps containing toothpaste in dentinal tubules occlusion.
Detailed description
Hypersensitivity has been defined as the pain arising from exposed dentin, typically in response to chemical, thermal, tactile or osmotic stimuli that cannot be explained as arising from any other form of dental defect or pathology. The pain of dentin hypersensitivity is classically, short, sharp, of rapid onset in character and of the duration of the applied stimuli. hypersensitivity was first documented by Blum. Although much has been learnt about hypersensitivity overtime, yet the mechanism of pain was explained by several hypotheses welling to be aware about the nature of the Disease firstly was the hypothesis that dentin was innervated and therefore, nerves were directly triggered by the stimulus. A further theory, termed the odontoblast transducer mechanism. Currently, the most widely accepted theory is the hydrodynamic theory which determined that there was an outward flow of fluid along the dentinal tubules.
In addition to extrapolation of the pain mechanism, allocating the etiology and the risk factors have a crucial impact on the disease outcome as well as the line of treatment. For hypersensitivity to occur lesion localization, where the dentin surface of a tooth must be exposed. And a lesion initiation must take place where the number of dentin tubules in close proximity to each other must be patent from the pulp to the oral environment.
Several in vitro and in situ data, case report data and epidemiological surveys summarized the most common etiologic and risk factors in the two main causes: gingival recession exposing dentin, either by periodontal Disease, zealous brushing, smoking and loss of hard tissue exposing dentin, also by frank carious lesions with dentin exposure of smooth tooth surface or development of non-carious cervical lesions.
Eventually based on the great knowledge about hypersensitivity nature, Etiologic and risk factors the dental professionals can now select the appropriate line of treatment either with conservative non-surgical intervention ex; Elimination of etiological factors, addition of desensitizers to toothpastes like Potassium nitrate, Strontium, Arginine and Calcium Carbonate, Calcium Sodium Phosphosilicate. Use of Dentin desensitizing products which have different ingredients, such as fluoride, hydroxyethyl methacrylate, glutaraldehyde, oxalate and potassium nitrate, as well as a combination of these ingredients.
Several in vitro, in situ as well as in vivo studies tackled the immense remineralizing capabilities of calcium silicate and it's in vitro promising results in formation of hydroxyapatite on enamel as well as occluding dentinal tubules thus giving potential anti-hypersensitivity benefits. However in vivo anti-hypersensitivity benefits were not tackled enough in literature.
This study will be performed to clinically assess the effect of toothpaste loaded with calcium silicate Nanoparticles (CS NPs) and compare it to one loaded with Sodium fluoride Nanoparticles (NaFL NPs) in the management of dentin hypersensitivity and laboratory investigating their efficacy in dentinal tubules occlusion. The null Hypothesis is the CS NPs has the same effect as Na FLNPs in the management of hypersensitivity complaining patient. The alternative hypothesis is the dentinal tubules occlusion by CSNPs will be like that one produced by Na FLNPs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each toothpaste will be applied uniformly twice per day (morning and bed time) to the hypersensitive surfaces for30 seconds. After that, the patient will rinse their mouth with plain water. Responses to the various stimuli will be evaluated using the same tactile and thermal stimuli used previously, and scores will be recorded 1day1,2 ,4 ,8 ,12 , weeks then 6 and 12 months after their application, respectively. Furthermore, the patients will be advised to report to the operator any unanticipated pain seizures, erroneous usage as well as the number of applications of a specific desensitizing agent required to elicit a positive response will also be recorded. The results will be statistically analyzed after 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Toothpaste containing calcium silicate nanoparticles | Active comparator | Other: toothpastepatients with hypersensitive areas will use the calcium silicate based toothpaste |
| Toothpaste containing sodium fluoride nanoparticles | Active comparator | Other: toothpastepatients with hypersensitive areas will use the sodium fluoride based toothpaste |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bicuspids, and first molars with exposed cervical dentine)
- Areas with hard tissue erosion
- cuneiform defect, pathological abrasion.
- Gingival recession
- Good overall physical health
Key exclusion criteria (9 listed)
- chipped teeth
- Defective restorations
- fractured un displaced cuspids
- deep dental caries
- deep periodontal pockets
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 |
|---|---|---|
| toothpastegroup of patients with hypersensitive areas will use the calcium silicate toothpaste twice per day (morning and bedtime) the toothpaste will be applied uniformly using medium toothbrush to the hypersensitive surfaces for 30seconds. After that, the patient will rinse their mouth with plain water. the other group of patients will use the sodium fluoride toothpaste twice per day (morning and bedtime). The toothpaste will be applied uniformly using a medium toothbrush to the hypersensitive areas for 30 seconds after that the patients will rinse their mouth with plain water | Other | Toothpaste containing calcium silicate nanoparticles, Toothpaste containing sodium fluoride nanoparticles |
Primary outcome
The Visual analogue scale
Time frame: one year
The Visual analogue scale on a scale (0 = no pain,10 = extreme pain).
The Verbal rating scale
Time frame: one year
The Verbal rating scale from to: (0 = no discomfort, 1=mild discomfort,2 = significant discomfort,3= significant discomfort lasting more than 10 seconds)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing toothpaste in people with Dentin Hypersensitivity, run by Minia 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 9 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: opening soon, as of the sponsor's last update on 11 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kareem A Lotfy, Assistant Lecturer (01117889888, kareem.lotfy82@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Visual analogue scale (time frame: one year). 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 11 May 2025.