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

August 29, 2023 updated by: Egymedicalpedia

The Effect of Egg Shell Nanoparticles Combined With Titanium Dioxide Nanoparticles on The Permeability of Dentinal Tubules After Exposure to Wear Challenges and Their Clinical Efficacy in The Treatment of Dentin Hypersensitivity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dentin desensitizing products, containing agents such as fluoride, strontium salts, oxalate, glutaraldehyde and bioactive glass, are employed to treat dentin hypersensitivity.

Based on the hydrodynamic theory, there are two main strategies for the treatment of dentin hypersensitivity as: (1) occluding the dentinal tubules to reduce the fluid flow, and (2) decreasing the excitability of the intradental nerve.

Although these products and agents were reported to be effective, short durability and poor effectiveness were often exhibited. The therapeutic effects of these desensitizing products were short lived on account of daily tooth brushing or drinking of acidic beverages and the occlusion effects were sometimes incomplete. Owing to these drawbacks, the use of nanomaterials as dentin occluding material has been predicted to be the future of treating DH.

Amorphous Calcium Phosphate (ACP) has the potential to remineralize the structure of tooth. ACP is a soluble calcium phosphate compound that discharges calcium and phosphate ions to change to apatite and remineralize the tooth structure when it comes in contact with saliva. Forming on the enamel and within the dental tubules, ACP provides a reservoir of phosphate and calcium ions in the saliva Casein phospho-peptide (CPP) is a milk-derived protein that joins to the tooth's biofilm and is applied to stabilize ACP. In recent years, remineralization products used CPP as a vehicle to deliver and preserve a super saturation state of ACP near the surface of tooth. A previous study showed that the application of (CPP-ACP) containing agents as GC tooth mousse and MI paste plus can reduce dentin permeability by occluding dentin tubules. It revealed that these materials can be effective for treatment of dentin hypersensitivity.

Recently, there has been a renewed interest in developing materials with a bioactive potential that could block the exposed dentinal tubules and subsequently reduce the fluid flow within the tubules. Eggshells (EBs) have been investigated in recent years for their remineralization capabilities. EB has rich bioavailable calcium content in the form of carbonates and oxides. It contains 94% calcium carbonate, 1% calcium phosphate, 1% magnesium carbonate, and 4% organic matter. In addition, eggshell provides a cost-effective, renewable, and sustainable source of material for EnHAp. A previous study revealed that eggshell powder is predicted to be the future of tooth remineralization and highly effective in occluding dentinal tubules and reducing dentin hypersensitivity.

Titanium dioxide is one of the few materials that classified as bioactive meaning that it enhances bone growth and stable bone bonding with dental implants via precipitation of hydroxyapatite on its surface

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistary - Al-Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

1- 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

Exclusion Criteria:

  • -- 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.

      2 -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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: first group (A1)
About 24 patients hypersensitive teeth. So the hypersensitive teeth will be treated with egg shell nanoparticles
Drug: Egg Shell nanoparticles
Evaluate the effects of egg shell nanoparticles combined with Titanium dioxide nanoparticles in the treatment of dentin hypersensitivity at different time intervals.
Other Names:
  • Titanium dioxide nanoparticles
Active Comparator: second group (A2)
About 24 patients hypersensitive teeth. treated with the combination therapy of eggshell and TiO2.
Drug: Egg Shell nanoparticles
Evaluate the effects of egg shell nanoparticles combined with Titanium dioxide nanoparticles in the treatment of dentin hypersensitivity at different time intervals.
Other Names:
  • Titanium dioxide nanoparticles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of dentin hypersensitivity
Time Frame: from baseline to 2 months after the treatment day.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egymedicalpedia

Investigators

  • Principal Investigator: Fatma Hussein, Lecturer, Al-Azhar Faculty of Dentistary for girls

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

March 15, 2023

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fadia Ali El-Sayed Shosha

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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