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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

kareem A Lotfy, Assistant Lecturer contact

01117889888

kareem.lotfy82@gmail.com

Mona I Riad, Professor contact

01006608683

monariad@dentistry.cu.edu.eg

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.

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 groups in NCT06557980
Study groupRoleWhat they receive
Toothpaste containing calcium silicate nanoparticlesActive comparatorpatients with hypersensitive areas will use the calcium silicate based toothpaste
Receives: Other: toothpaste
Toothpaste containing sodium fluoride nanoparticlesActive comparatorpatients 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.

  1. The Visual analogue scale

    The Visual analogue scale on a scale (0 = no pain,10 = extreme pain).

    Measured: one year

  2. 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.

  1. First posted16 Aug 2024
  2. Study startMay 2025 (estimated)
  3. Primary completionSep 2025 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

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)
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

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.

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