Clinical trial NCT06557980: Effectiveness of Calcium Silicate and Sodium Fluoride Nanoparticles in The Management of Dentin Hypersensitivity
Official title: Effectiveness of Calcium Silicate and Sodium Fluoride Nanoparticles in The Management of Dentin Hypersensitivity (Randomized Controlled Clinical Trial and In-Vitro Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dentin Hypersensitivity
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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 informed consent

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 hypersensitivity.
* 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.

Primary outcomes:
measure: The Visual analogue scale
timeFrame: one year
measure: The Verbal rating scale
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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