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

NCT06557980 | Not Yet Recruiting

• 1 other identifier: hypersensitivity management
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dentin Hypersensitivity

Outcome Measures

Primary Outcomes (2)

• The Visual analogue scale

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

  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)

  one year

Study Arms (2)

Toothpaste containing calcium silicate nanoparticles

ACTIVE COMPARATOR

patients with hypersensitive areas will use the calcium silicate based toothpaste

Other: toothpaste

Toothpaste containing sodium fluoride nanoparticles

ACTIVE COMPARATOR

patients with hypersensitive areas will use the sodium fluoride based toothpaste

Other: toothpaste

Interventions

toothpaste OTHER

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

Toothpaste containing calcium silicate nanoparticles; Toothpaste containing sodium fluoride nanoparticles

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Toothpastes

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

kareem A Lotfy, Assistant Lecturer

CONTACT

01117889888; kareem.lotfy82@gmail.com

Mona I Riad, Professor

CONTACT

01006608683; monariad@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The operator, the assessor as well as the data analyst will be blinded to material assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 16, 2024
• Study Start: May 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: for anyone