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Not yet recruitingNCT06557980Updated May 11, 2025

Effectiveness of Calcium Silicate and Sodium Fluoride Nanoparticles in The Management of Dentin Hypersensitivity

An interventional study of toothpaste in Dentin Hypersensitivity, sponsored by Minia University. Not yet recruiting. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-11.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Dentin Hypersensitivity

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03

In context

Dentin Sensitivity

288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 .
  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Toothpaste containing calcium silicate nanoparticles

    patients with hypersensitive areas will use the calcium silicate based toothpaste

    Other: toothpaste

  • Active comparator
    Toothpaste containing sodium fluoride nanoparticles

    patients with hypersensitive areas will use the sodium fluoride based toothpaste

    Other: toothpaste

Interventions

  • Othertoothpaste

    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

06

What researchers measure

Primary outcomes

  1. The Visual analogue scale

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

    Time frame: 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)

    Time frame: one year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Access criteria: for anyone

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2025; primary completion for Sep 2025, 4 months later.

Of 111 non-industry interventional studies with no phase under Dentin Sensitivity, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 12. This study's planned 4 months is below that.

Counting every sponsor, half of 144 studies reached it within 6 months; a quarter within 3 and three quarters within 10.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 7, 2024
First posted
Aug 16, 2024
StartEst.
May 2025
Primary completionEst.
Sep 2025
CompletionEst.
Oct 2025
Last update
May 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06557980
Lead sponsor
Minia University
Responsible party
Kareem Abd El Hamid Lotfy (Assistant Lecturer, Minia University) — Principal investigator
First posted
Aug 16, 2024
Start date
May 2025 (estimated)
Primary completion
Sep 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
May 11, 2025

Study contacts

kareem A Lotfy, Assistant Lecturer
Contact
kareem.lotfy82@gmail.com
01117889888
Mona I Riad, Professor
Contact
monariad@dentistry.cu.edu.eg
01006608683

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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