Exposed Hypersensitive Dentin Treated With Fluoride Iontophoresis With Remineralizing Agents

NCT06837779 | Enrolling By Invitation DMC

• 1 other identifier: FDAZUC-REC1009/2074
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Dentin Hypersensitivity

Keywords

hypersinsitivity; flouride iontophoresis

Outcome Measures

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

  12 months

Study Arms (2)

Fluoride Iontophoresis with Acidulated Phosphate Fluoride gel

EXPERIMENTAL

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

remineralizing agents

ACTIVE COMPARATOR

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

Drug: Remineralization with sodium fluoride varnish

Interventions

Fluoride Iontophoresis with Acidulated Phosphate Fluoride DRUG

Application of fluoride gel and activated with Iontophoresis electrical pole

Fluoride Iontophoresis with Acidulated Phosphate Fluoride gel

Remineralization with sodium fluoride varnish DRUG

CASIN PHOSPHOPEPTIDE AMORPHOUS CALCIUM PHOSPHATE

remineralizing agents

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of Dental Medicine ,Alazhar Univerisity

Cairo, Cairo Governorate, 11768, Egypt

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Acidulated Phosphate Fluoride

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phosphates; Phosphoric Acids; Phosphorus Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Sodium Fluoride; Fluorides; Hydrofluoric Acid; Fluorine Compounds; Phosphorus Compounds; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Mohamed Wakwak, A

  Alazhar Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCITE PROFESSOR OF OPERATIVE DENTISTRY

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: February 20, 2025
• Study Start: July 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)