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

Primary Purpose

Dentin Hypersensitivity

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Egg Shell nanoparticles
Sponsored by
Egymedicalpedia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Hypersensitivity

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Dentistary - Al-Azhar University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

first group (A1)

second group (A2)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 29, 2023
Last Updated
August 29, 2023
Sponsor
Egymedicalpedia
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1. Study Identification

Unique Protocol Identification Number
NCT06025084
Brief Title
The Effect of the Egg Shell Nanoparticles Combined With Titanium Dioxide Nanoparticles
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
first group (A1)
Arm Type
Active Comparator
Arm Description
About 24 patients hypersensitive teeth. So the hypersensitive teeth will be treated with egg shell nanoparticles
Arm Title
second group (A2)
Arm Type
Active Comparator
Arm Description
About 24 patients hypersensitive teeth. treated with the combination therapy of eggshell and TiO2.
Intervention Type
Drug
Intervention Name(s)
Egg Shell nanoparticles
Other Intervention Name(s)
Titanium dioxide nanoparticles
Intervention Description
Evaluate the effects of egg shell nanoparticles combined with Titanium dioxide nanoparticles in the treatment of dentin hypersensitivity at different time intervals.
Primary Outcome Measure Information:
Title
Assessment of dentin hypersensitivity
Description
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.
Time Frame
from baseline to 2 months after the treatment day.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Hussein, Lecturer
Organizational Affiliation
Al-Azhar Faculty of Dentistary for girls
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistary - Al-Azhar University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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

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