Exposed Hypersensitive Dentin Treated with Fluoride Iontophoresis with Remineralizing Agents

Not Applicable

• Conditions: Dentin Hypersensitivity
• Interventions: Drug: Fluoride Iontophoresis with Acidulated Phosphate Fluoride; Drug: Remineralization with sodium fluoride varnish

• Registration Number: NCT06837779
• Lead Sponsor: Al-Azhar University

Brief 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

Detailed Description

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

Study Timeline

• Study Start: 2024-07-01
• Study First Submitted: 2024-11-29
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-08-01
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluoride Iontophoresis with Acidulated Phosphate Fluoride gel	Fluoride Iontophoresis with Acidulated Phosphate Fluoride	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.
remineralizing agents	Remineralization with sodium fluoride varnish	All remineralizing agents (Casein phosphopeptides -Amorphus Calcium Phosphate, Nano-hydroxyapatite, and Bioactive glass).

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	12 months	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

Trial Locations

Locations (1)

Faculty of Dental Medicine ,Alazhar Univerisity; 🇪🇬 Cairo, Egypt