Exposed Hypersensitive Dentin Treated with Fluoride Iontophoresis with Remineralizing Agents

Clinical Evaluation of Exposed Hypersensitive Dentin Treated with Fluoride Iontophoresis Application in Comparison with Two Different Remineralizing Agents (a Randomized Clinical Trial)

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Dentin Hypersensitivity
• Intervention / Treatment: Drug: Fluoride Iontophoresis with Acidulated Phosphate Fluoride; Drug: Remineralization with sodium fluoride varnish

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11768
    • Faculty of Dental Medicine ,Alazhar Univerisity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Application of fluoride gel and activated with Iontophoresis electrical pole
Active Comparator: remineralizing agents; All remineralizing agents (Casein phosphopeptides -Amorphus Calcium Phosphate, Nano-hydroxyapatite, and Bioactive glass).	Drug: Remineralization with sodium fluoride varnish; CASIN PHOSPHOPEPTIDE AMORPHOUS CALCIUM PHOSPHATE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Mohamed Wakwak, A, Alazhar Univeristy

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: hypersinsitivity; flouride iontophoresis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Immune System Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Anti-Infective Agents; Physiological Effects of Drugs; Protective Agents; Anti-Infective Agents, Local; Cariostatic Agents; Fluorides; Listerine; Sodium Fluoride; Fluorides, Topical
• Other Study ID Numbers: FDAZUC-REC1009/2074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: privacy of patient may be may be photo of device used in the study , photo of treatment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No