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NCT Number: NCT06493500

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eggshell derived Nano-hydroxyapatite (n-HAp) with a Fluoride containing toothpaste

Drug

patients would be instructed to treat their teeth for 5 min twice a day with the provided toothpaste.

Other names: (n-HAp) toothpaste

Eggshell derived Nano-hydroxyapatite (n-HAp) without a Fluoride containing toothpaste

Drug

patients would be instructed to treat their teeth for 5 min twice a day with the provided toothpaste.

Other names: nano-hydroxyapatite with flouride

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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