Dentin HypersensitivityNCT07120139
Clinical Effectiveness of Episodic Use of Bioactive Silica Based Versus in Management of Dentin Hypersensitivity (A 6m Randomized Clinical Trial)
A study testing episodic use of the desensitizing toothpaste and continuous use of the conventional desensitizing toothpaste in people with Dentin Hypersensitivity, run by Rawda Hesham Abd ElAziz at 1 site in Egypt.
Trial summary
The aim of the study to compare the clinical effectiveness of Episodic use of Bioactive Silica Based versus continuous use of fluoride based desensitizing toothpastes in management of dentin hypersensitivity (DH) of adult patients over 6m follow up and evaluating patient satisfaction regarding the treatment provided. Read more about this study
- Who is it for?
- Ages 22 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- episodic use of the desensitizing toothpaste and continuous use of the conventional desensitizing toothpaste
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2025to 28 Feb 2026
- 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 22 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with DH, VAS ≥ 3 and Schiff sensitivity score needed to be ≥2, indicating that application of a jet of air makes the patient respond and move or requests discontinuation of the stimuli application.
- Teeth with DH related to Non- carious Cervical lesions (abrasion, abfracture, erosion).
- Teeth with gingival recession and exposed root dentin.
- -
Who cannot join
- Patients with known allergies or adverse reactions to any ingredient of the tested materials.
- Systematic disease and/ or physical disabilities that may affect participation. • Patients who did any periodontal surgeries within the previous 3 months.
- Patients with orthodontic appliances, or restorative work that might interfere with evaluation.
- Patient who frequently use analgesics or any drugs that could affect the pain level.
- Home or in-office bleaching and/ or in office fluoride application for 6 months before beginning of treatment.
- Pregnant females with frequent vomiting attacks.
Show all 9Show fewer
- Smokers.
- Systemic conditions that cause or predispose patients to develop dentin hypersensitivity (for example, gastroesophageal reflux disease, GERD).
- Excessive dietary or environmental exposure to acids.
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
Cairo University
Cairo, 11331
Rawda Hesham ElAziz, 01001097200, rawda.hesham@dentistry.cu.edu.eg
About this study
Official title: Clinical Effectiveness of Episodic Use of Bioactive Silica Based Versus Continuous Use of Fluoride Desensitizing Toothpastes in Management of Dentin Hypersensitivity (A 6m Randomized Clinical Trial)
The aim of the study to compare the clinical effectiveness of Episodic use of Bioactive Silica Based versus continuous use of fluoride based desensitizing toothpastes in management of dentin hypersensitivity (DH) of adult patients over 6m follow up and evaluating patient satisfaction regarding the treatment provided. Episodic use will be tested as it reflects the effectiveness in a clinical scenario regarding patient compliance and adherence to the treatment where some of the Egyptian patients stop the treatment once improvement occurs due to financial constraints
- Conditions
- Dentin Hypersensitivity
- Being tested
- episodic use of the desensitizing toothpaste, continuous use of the conventional desensitizing toothpaste
- Keywords
- Bioactive Silica Based with calcium booster (Refix technology) toothpaste, Dentin hypersensitivity.
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
episodic use of the desensitizing toothpasteProcedure or surgery
subjects assigned to episodic treatment will use the assigned toothpaste with the same previous instructions for two 8-week treatment periods, followed by an 8-week phase in which they will use the conventional fluoride dentifrice (Signal Complete 8 Original, Unilever, Egypt), which has no documented desensitizing efficacy
continuous use of the conventional desensitizing toothpasteProcedure or surgery
The patients will be instructed to use 1 inch amount of the assigned desensitizing toothpaste and soft bristle toothbrushes with the same brushing technique they will be taught in the intervention visit for 2 minutes twice a day (morning and last thing at night ) without further rinsing, only spitting of the excess material every day along the whole study period for the continuous treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Episodic use of Refix booster Bioactive Silica with calcium booster toothpaste | Experimental | Not described Receives: Procedure: episodic use of the desensitizing toothpaste |
| Group 2: Episodic use of Regenerador Sentitive: Bioactive Silica Based toothpaste, | Experimental | Not described Receives: Procedure: episodic use of the desensitizing toothpaste |
| Group 3: Episodic use of (Sensodyne Rapid action) Fluoride containing desensitizing Toothpaste, | Experimental | Not described Receives: Procedure: episodic use of the desensitizing toothpaste |
| Group 4: Continuous use of (Sensodyne Rapid action) Fluoride containing desensitizing Toothpaste | Active comparator | Not described Receives: Procedure: continuous use of the conventional desensitizing toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Dentin hypersensitivity
Visual analog scale (VAS)
Measured: change from the baseline, 1month, 2months, 4 months, 6 months after treatment
Secondary outcomes (2)
Examiner Assessment to level of patient pain
Schiff sensitivity scale [SSS]
Measured: change from the baseline, 1month, 2months, 4 months, 6 months after treatment
Patient satisfaction with the Treatment
4-point Likert scale
Measured: change from the baseline, 1month, 2months, 4 months, 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completion20 Feb 2026 (estimated)
- Study completion28 Feb 2026 (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.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rawda Hesham Abd ElAziz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rawda Hesham Abd ElAziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120139
- Sponsor's protocol ID
- CONS2R
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Episodic Use of Bioactive Silica Based Versus Continuous Use of Fluoride Desensitizing Toothpastes in Management of Dentin Hypersensitivity (A 6m Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07120139
- Acronym / sponsor ID
- CONS2R
- Conditions
- Dentin Hypersensitivity
- Keywords
- Bioactive Silica Based with calcium booster (Refix technology) toothpaste, Dentin hypersensitivity.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rawda Hesham Abd ElAzizUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 13 Aug 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 aim of the study to compare the clinical effectiveness of Episodic use of Bioactive Silica Based versus continuous use of fluoride based desensitizing toothpastes in management of dentin hypersensitivity (DH) of adult patients over 6m follow up and evaluating patient satisfaction regarding the treatment provided. Episodic use will be tested as it reflects the effectiveness in a clinical scenario regarding patient compliance and adherence to the treatment where some of the Egyptian patients stop the treatment once improvement occurs due to financial constraints
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 Episodic use of Refix booster Bioactive Silica with calcium booster toothpaste | Experimental | Procedure: episodic use of the desensitizing toothpaste |
| Group 2: Episodic use of Regenerador Sentitive: Bioactive Silica Based toothpaste, | Experimental | Procedure: episodic use of the desensitizing toothpaste |
| Group 3: Episodic use of (Sensodyne Rapid action) Fluoride containing desensitizing Toothpaste, | Experimental | Procedure: episodic use of the desensitizing toothpaste |
| Group 4: Continuous use of (Sensodyne Rapid action) Fluoride containing desensitizing Toothpaste | Active comparator | Procedure: continuous use of the conventional desensitizing toothpaste |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with DH, VAS ≥ 3 and Schiff sensitivity score needed to be ≥2, indicating that application of a jet of air makes the patient respond and move or requests discontinuation of the stimuli application.
- Teeth with DH related to Non- carious Cervical lesions (abrasion, abfracture, erosion).
- Teeth with gingival recession and exposed root dentin.
- -
Key exclusion criteria (9 listed)
- Patients with known allergies or adverse reactions to any ingredient of the tested materials.
- Systematic disease and/ or physical disabilities that may affect participation. • Patients who did any periodontal surgeries within the previous 3 months.
- Patients with orthodontic appliances, or restorative work that might interfere with evaluation.
- Patient who frequently use analgesics or any drugs that could affect the pain level.
- Home or in-office bleaching and/ or in office fluoride application for 6 months before beginning of treatment.
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 |
|---|---|---|
| episodic use of the desensitizing toothpastesubjects assigned to episodic treatment will use the assigned toothpaste with the same previous instructions for two 8-week treatment periods, followed by an 8-week phase in which they will use the conventional fluoride dentifrice (Signal Complete 8 Original, Unilever, Egypt), which has no documented desensitizing efficacy | Procedure or surgery | Group 1 Episodic use of Refix booster Bioactive Silica with calcium booster toothpaste, Group 2: Episodic use of Regenerador Sentitive: Bioactive Silica Based toothpaste,, Group 3: Episodic use of (Sensodyne Rapid action) Fluoride containing desensitizing Toothpaste, |
| continuous use of the conventional desensitizing toothpasteThe patients will be instructed to use 1 inch amount of the assigned desensitizing toothpaste and soft bristle toothbrushes with the same brushing technique they will be taught in the intervention visit for 2 minutes twice a day (morning and last thing at night ) without further rinsing, only spitting of the excess material every day along the whole study period for the continuous treatment group. | Procedure or surgery | Group 4: Continuous use of (Sensodyne Rapid action) Fluoride containing desensitizing Toothpaste |
Primary outcome
Degree of Dentin hypersensitivity
Time frame: change from the baseline, 1month, 2months, 4 months, 6 months after treatment
Visual analog scale (VAS)
2 secondary outcomes
Examiner Assessment to level of patient pain
Time frame: change from the baseline, 1month, 2months, 4 months, 6 months after treatment
Patient satisfaction with the Treatment
Time frame: change from the baseline, 1month, 2months, 4 months, 6 months after treatment
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 13 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing episodic use of the desensitizing toothpaste and continuous use of the conventional desensitizing toothpaste in people with Dentin Hypersensitivity, run by Rawda Hesham Abd ElAziz 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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 13 Aug 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?
Contact Rawda Hesham Abd ElAziz (+201001097200, rawda.hesham@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Dentin hypersensitivity (time frame: change from the baseline, 1month, 2months, 4 months, 6 months after treatment). 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 13 Aug 2025.