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Enrolling by invitationNCT06837779Updated Feb 20, 2025

Exposed Hypersensitive Dentin Treated with Fluoride Iontophoresis with Remineralizing Agents

An interventional study of Fluoride Iontophoresis with Acidulated Phosphate Fluoride and Remineralization with sodium fluoride varnish in Dentin Hypersensitivity, sponsored by Al-Azhar University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as enrolling by invitation.
  • Registered 4 months after the study started (first participant enrolled Jul 2024, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
35 Years to 60 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn if the application of fluoride works to treat patients suffering from dentin hypersensitivity. It will also learn about the safety of using fluoride iontophoresis with Acidulated phosphate fluoride gel.

The main questions it aims to answer are:

Does the remineralizing agent have the ability to decrease dentin sensitivity?

Researchers will compare Fluoride Iontophoresis with Acidulated Phosphate Fluoride gel , Casein phosphopeptides-Amorphus calcium phosphate (CPP-ACP), nano-hydroxyapptite (NHAP) and -active glass in decreasing dentin hypersensitivity

.

Participants will:

  • Application of remineralizing agent every 3 months
  • Visit the dental clinic once every 3 months for checkups and tests
Read the detailed description

Assess the efficacy of fluoride iontophoresis in remineralization in comparison with other ingredients.

02

Conditions studied

  • Dentin Hypersensitivity

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Keywords

  • hypersinsitivity
  • flouride iontophoresis
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 20 is below the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
35 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

  • Patients within 35-60 years of age.
  • Each patient has 4 or more exposed roots of posterior teeth having sensitivity.
  • Good oral hygiene.
  • Patients who will agree to the consent and will commit to the follow-up period.
  • Patients will follow instructions during study time.
  • Teeth that were vital.

Exclusion criteria

Exclusion Criteria:

  • Patients with any systemic disease that may affect normal healing.
  • Patient with bad oral hygiene, high caries index and high plaque index
  • Patients participating in more than 1 dental study.
  • Active carious lesions.
  • Intrinsic and extrinsic stains.
  • Any previous filling of selected teeth.
  • Cracked and malformed teeth.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Fluoride Iontophoresis with Acidulated Phosphate Fluoride gel

    assessmen of iontophoresis effect on flouride ions flush to remineralization of demineralized enamel .The treatment will be assessed and recorded using VAS score immediately after the intervention, 3 months, 6 months and one year later.

    Drug: Fluoride Iontophoresis with Acidulated Phosphate Fluoride

  • Active comparator
    remineralizing agents

    All remineralizing agents (Casein phosphopeptides -Amorphus Calcium Phosphate, Nano-hydroxyapatite, and Bioactive glass).

    Drug: Remineralization with sodium fluoride varnish

Interventions

  • DrugFluoride Iontophoresis with Acidulated Phosphate Fluoride

    Application of fluoride gel and activated with Iontophoresis electrical pole

  • DrugRemineralization with sodium fluoride varnish

    CASIN PHOSPHOPEPTIDE AMORPHOUS CALCIUM PHOSPHATE

06

What researchers measure

Primary outcomes

  1. Visual Analogue Scale

    Measurement of sensitivity was performed after each stimulus by a Visual Analogue Scale, which consists of a 10-cm long line; the minimum value is 0 and the maximum value is 10, whether the higher scores mean worse and the lower score means better outcome. The patient's pain limits can suffer through an external stimulus; at 0, one end represents absence of discomfort, and the other represents severe discomfort caused by certain stimuli. Each time the patient is subjected to a stimulus, he or she is requested to point at the interval from 0 to 10, a number to correspond to the pain felt. The convenience of this type of scale is to allow demonstration of the pain intensity with absolute numbers or as a percentage of a maximum value

    Time frame: 12 months

07

Study locations

1 site
  • Faculty of Dental Medicine ,Alazhar Univerisity
    Cairo, 11768, Egypt
08

References and documents

Individual participant data

Plan to share: No — privacy of patient may be may be photo of device used in the study , photo of treatment

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06837779
Responsible party
Mohamed Wakwak (ASSOCITE PROFESSOR OF OPERATIVE DENTISTRY, Al-Azhar University) — Principal investigator
First posted
Feb 20, 2025
Start date
Jul 1, 2024
Primary completion
Aug 1, 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Feb 20, 2025

Study contacts

Mohamed Wakwak, A
principal investigator · Alazhar Univeristy

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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