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Not yet recruitingNCT06493500Updated Jul 10, 2024

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

A Phase 1 interventional study of Eggshell derived Nano-hydroxyapatite (n-HAp) with a Fluoride containing toothpaste and Eggshell derived Nano-hydroxyapatite (n-HAp) without a Fluoride containing toothpaste in Dentin Hypersensitivity, Fluoride and Nano-hydroxy Apatite, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-10.

Sponsored by Cairo University · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

Read the 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

02

Conditions studied

  • Dentin Hypersensitivity
  • Fluoride
  • Nano-hydroxy Apatite

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03

In context

Dentin Sensitivity

288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.

This study's planned enrollment of 39 is below the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , VAS ≥5
  • Co-operative patients who show interest to participate in the study.

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
39 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugEggshell 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.

    Also known as: (n-HAp) toothpaste

  • DrugEggshell 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.

    Also known as: nano-hydroxyapatite with flouride

06

What researchers measure

Primary outcomes

  1. Pain intensity due to Dentin Hypersensitivity by Visual Analogue Scale (VAS)

    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.

    Time frame: T (Time): T0= Baseline (before treatment). T1= 7 days. T2= 3 months. T3= 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06493500
Lead sponsor
Cairo University
Responsible party
shahenda gamal tawfik hamdy (dentist, Cairo University) — Principal investigator
First posted
Jul 10, 2024
Start date
Jul 2024 (estimated)
Primary completion
Feb 2025 (estimated)
Completion
Mar 2025 (estimated)
Last update
Jul 10, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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