Efficacy of Formulated Eggshell Derived Nano-hydroxyapatite Containing Toothpaste With and Without Addition of Fluoride vs. Conventional Desensitizing Fluoride Containing Toothpaste in Management of Dentin Hypersensitivity

July 6, 2024 updated by: shahenda gamal tawfik hamdy, Cairo University

Efficacy of Nano-hydroxyapatite Containing Tooth Paste on Dentin Hypersensitivity of Adult Patient

compare the effectiveness of Eggshell derived nano-Hydroxyapatite with and without fluoride and conventional fluoride containing tooth paste versus conventional desensitizing fluoride containing tooth paste on dentinal tubule occlusion and dentin mineral deposition.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Recently advanced nanotechnology has taken a wide leap in improving the various measures in the treatment of hypersensitivity by its nanoparticles. Nanoparticles can easily penetrate into dentin tubules, which could act as mineralizing agents that block fluid movement within the dentin tubules when combined with various agents.

Hydroxyapatite (HAp) is the major inorganic component of natural teeth and bone. Nano-sized particles of hydroxyapatite are similar to the apatite crystals of tooth enamel in morphology and crystal structure and has been studied as a biomimetic material for the reconstruction of tooth enamel suffering from mineral loss because of its unique potential for remineralization. Nano-hydroxyapatite (n-HAp) was considered a promising active ingredient used for the treatment of DH due to high biocompatibility and bioactivity. In toothpastes, HAp was included in the form of nanocrystals because they dissolve easier in this form. Crystals of n-HAp included in dental products have a dimension of 50-1000 nm, which enables them to act like fillers. These products can penetrate and block the exposed dentinal tubules which are responsible for DH

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Phase 1

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

Yes

Description

Inclusion Criteria:

  • Adult Patients Aged 18-60
  • Males or females.
  • Good oral hygiene
  • Absence of abnormal occlusion habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).
  • Teeth with hypersensitivity, VAS ≥5
  • Co-operative patients who show interest to participate in the study.

Exclusion Criteria:

  • Patients with known allergic or adverse reaction to the tested materials.
  • Systematic disease that may affect participation.
  • Xerostomic patients.
  • Patients with bad oral hygiene
  • Patients with orthodontic appliances, or bridge work that might interfere with evaluation
  • Patients who did any periodontal surgeries within the previous 6 months.
  • Patients with physical disabilities

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eggshell derived Nano-hydroxyapatite (n-HAp) with Fluoride containing toothpaste
patients would be instructed to treat their teeth for 5 min twice a day with the provided toothpaste.
Drug: Eggshell derived Nano-hydroxyapatite (n-HAp) with a Fluoride containing toothpaste
patients would be instructed to treat their teeth for 5 min twice a day with the provided toothpaste.
Other Names:
  • (n-HAp) toothpaste
Experimental: Eggshell derived Nano-hydroxyapatite (n-HAp) without Fluoride containing toothpaste
patients would be instructed totreat their teeth for 5 min twice a day with the provided toothpaste.
Drug: Eggshell derived Nano-hydroxyapatite (n-HAp) without a Fluoride containing toothpaste
patients would be instructed to treat their teeth for 5 min twice a day with the provided toothpaste.
Other Names:
  • nano-hydroxyapatite with flouride
Active Comparator: Commercially available Fluoride containing toothpaste (Sensodyne Rapid Relief)
patients would be instructed totreat their teeth for 5 min twice a day with the provided toothpaste.
Drug: Eggshell derived Nano-hydroxyapatite (n-HAp) with a Fluoride containing toothpaste
patients would be instructed to treat their teeth for 5 min twice a day with the provided toothpaste.
Other Names:
  • (n-HAp) toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity due to Dentin Hypersensitivity by Visual Analogue Scale (VAS)
Time Frame: T (Time): T0= Baseline (before treatment). T1= 7 days. T2= 3 months. T3= 6 months
VAS is used to "quantify" the pain severity in millimeter (mm) in response to such query as "Draw a line on the scale that shows how much pain you have at this time " with "no pain" on the far left end of scale at 0 mm and "pain as bad as it can be" on the far right at 100 mm.
T (Time): T0= Baseline (before treatment). T1= 7 days. T2= 3 months. T3= 6 months

Collaborators and Investigators

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

Sponsor

Cairo University

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 (Estimated)

July 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

June 30, 2024

First Submitted That Met QC Criteria

July 6, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 6, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cebc-cu-2024-06-30

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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