Dentin HypersensitivityNCT06837779
Exposed Hypersensitive Dentin Treated With Fluoride Iontophoresis With Remineralizing Agents
A study testing Fluoride Iontophoresis with Acidulated Phosphate Fluoride and Remineralization with sodium fluoride varnish in people with Dentin Hypersensitivity, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Fluoride Iontophoresis with Acidulated Phosphate Fluoride and Remineralization with sodium fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dental Medicine ,Alazhar Univerisity
Cairo, Cairo Governorate, 11768
About this study
Official title: 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:
Read more
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.
- Conditions
- Dentin Hypersensitivity
- Being tested
- Fluoride Iontophoresis with Acidulated Phosphate Fluoride, Remineralization with sodium fluoride varnish
- Keywords
- hypersinsitivity, flouride iontophoresis
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride Iontophoresis with Acidulated Phosphate FluorideDrug
Application of fluoride gel and activated with Iontophoresis electrical pole
Remineralization with sodium fluoride varnishDrug
CASIN PHOSPHOPEPTIDE AMORPHOUS CALCIUM PHOSPHATE
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fluoride Iontophoresis with Acidulated Phosphate Fluoride |
| remineralizing agents | Active comparator | All remineralizing agents (Casein phosphopeptides -Amorphus Calcium Phosphate, Nano-hydroxyapatite, and Bioactive glass). Receives: Drug: Remineralization with sodium fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Jul 2024
- Primary completion1 Aug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin HypersensitivityStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Wakwak, Al-Azhar University
- Investigators
- Mohamed Wakwak, A, Principal investigator, Alazhar Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837779
- Sponsor's protocol ID
- FDAZUC-REC1009/2074
- Status last verified
- Feb 2025
- First submitted
- 29 Nov 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: privacy of patient may be may be photo of device used in the study , photo of treatment
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Exposed Hypersensitive Dentin Treated With Fluoride Iontophoresis Application in Comparison With Two Different Remineralizing Agents (a Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06837779
- Acronym / sponsor ID
- FDAZUC-REC1009/2074
- Conditions
- Dentin Hypersensitivity
- Keywords
- hypersinsitivity, flouride iontophoresis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoride Iontophoresis with Acidulated Phosphate Fluoride gel | Experimental | Drug: Fluoride Iontophoresis with Acidulated Phosphate Fluorideassessmen 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 | Active comparator | Drug: Remineralization with sodium fluoride varnishAll remineralizing agents (Casein phosphopeptides -Amorphus Calcium Phosphate, Nano-hydroxyapatite, and Bioactive glass). |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoride Iontophoresis with Acidulated Phosphate FluorideApplication of fluoride gel and activated with Iontophoresis electrical pole | Drug | Fluoride Iontophoresis with Acidulated Phosphate Fluoride gel |
| Remineralization with sodium fluoride varnishCASIN PHOSPHOPEPTIDE AMORPHOUS CALCIUM PHOSPHATE | Drug | remineralizing agents |
Primary outcome
Visual Analogue Scale
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No. privacy of patient may be may be photo of device used in the study , photo of treatment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Wakwak, A principal investigator
Alazhar Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoride Iontophoresis with Acidulated Phosphate Fluoride and Remineralization with sodium fluoride varnish in people with Dentin Hypersensitivity, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.