The Effect of the Egg Shell Nanoparticles Combined With Titanium Dioxide Nanoparticles

NCT06025084 | Completed Phase 1 DMC

• 1 other identifier: Fadia Ali El-Sayed Shosha
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Dentin hypersensitivity is one of the most commonly occurring clinical dental conditions which is characterized by short and sharp pain which arises from exposed dentin in response to external stimuli, which typically are thermal, evaporative, tactile, osmotic or chemical. Hypersensitive dentin is mostly found in buccal tooth areas, in which enamel is missing because of abrasion, attrition, or erosion. The most generally accepted theory regarding the mechanism of dentin hypersensitivity is the hydrodynamic theory. It proposes that a pain-provoking stimulus increases the flow of the dentinal tubular fluid and consequently, stimulates the nerves around the odontoblasts, leading to dentin hypersensitivity.

Conditions

Dentin Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Assessment of dentin hypersensitivity

  The pain response will be assessed using the numerical Visual Analogue Scale (VAS, range 0-10), with 0 indicating 'no pain' and 10 indicating 'intolerably severe pain.

  from baseline to 2 months after the treatment day.

Study Arms (2)

first group (A1)

ACTIVE COMPARATOR

About 24 patients hypersensitive teeth. So the hypersensitive teeth will be treated with egg shell nanoparticles

Drug: Egg Shell nanoparticles

second group (A2)

ACTIVE COMPARATOR

About 24 patients hypersensitive teeth. treated with the combination therapy of eggshell and TiO2.

Drug: Egg Shell nanoparticles

Interventions

Egg Shell nanoparticles DRUG

Evaluate the effects of egg shell nanoparticles combined with Titanium dioxide nanoparticles in the treatment of dentin hypersensitivity at different time intervals.

Also known as: Titanium dioxide nanoparticles

first group (A1); second group (A2)

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• For patients;
• Age between 20 and 55 years
• Patients in good systemic health with clinically elicitable dentin hypersensitivity
• Absence of contraindications to the proposed therapies as allergy. 2 - For teeth;
• Absence of local pathologies (e.g., caries and fractures)
• Visual analog scale (VAS) score ≥3

You may not qualify if:

• \-- For patients;
• Use of any desensitizing toothpaste for previous 3 or 4 months.
• Taking analgesics/anti-inflammatory drugs at the time of the study, pregnancy, and smoking.
• For teeth ;
• Teeth with abrasion and attrition.
• Carious lesions on the selected or neighboring teeth, defective restorations
• Any professional desensitizing therapy on the selected teeth during the last 6 months.

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Faculty of Dentistary - Al-Azhar University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Fatma Hussein, Lecturer

  Al-Azhar Faculty of Dentistary for girls

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 6, 2023
• Study Start: December 1, 2022
• Primary Completion: March 15, 2023
• Study Completion: March 30, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-08

Locations

EG (1)