Dentin SensitivityNCT04340869
Treatment of Dentin Hypersensitivity Using Different Desensitizing Agents
A study testing Theobromine and Remin Pro in people with Dentin Sensitivity, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Treatment of Dentin Hypersensitivity Using Theobromine , Remin Pro , and Combination of Both Materials Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Theobromine and Remin Pro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients that aged 18-50 years.
- Patients in good general health.
- Patients that have accessible teeth demonstrating signs of sensitivity.
Who cannot join
- • Any chronic debilitating disease that could influence study outcomes.
- Partial dentures, orthodontic appliances, implants or restorations in a poor state of repair that could influence study outcomes.
- Intolerance or hypersensitivity to the study desensitizing agents or their ingredients.
- Desensitising treatment or tooth bleaching within 8 weeks of screening.
- Daily use of medications that might influence the perception of pain.(
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University , Faculty of Dental medicine for Girls
Cairo, 11111
Ebtsam Kassab, +201005889938, dentiebtsamkassab@gmail.com
About this study
Official title: The Effect of Using Two Desensitizing Agents Alone and In Combination on Dentin Permeability and Hypersensitivity
Treatment of Dentin Hypersensitivity Using Theobromine , Remin Pro , and Combination of Both Materials
- Conditions
- Dentin Sensitivity
- Being tested
- Theobromine, Remin Pro
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheobromineOther
Natural extract from Cocoa
Remin ProOther
Remin Pro
| Study group | Role | What they receive |
|---|---|---|
| Theobromine | Experimental | Natural extract from Cocoa Receives: Other: Theobromine |
| Remin Pro | Active comparator | Fluoride , Hydroxyapatite , and Xylitol Receives: Other: Remin Pro |
| Combination | Experimental | Remin Pro and Theobromine Receives: Other: Theobromine; Other: Remin Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale pain score
0 = no pain to 10=severe exagerated pain
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Aug 2019
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dentin SensitivityStudies 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
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ebtsam kassab, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340869
- Sponsor's protocol ID
- REC18-145
- Status last verified
- Apr 2020
- First submitted
- 2 Mar 2020
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kassab EE, Niazy MA, El Yasky MA, Ameen SM. Clinical effectiveness of theobromine, Remin Pro, and their combination in managing dentin hypersensitivity: a randomized clinical trial. BMC Oral Health. 2026 Oct 2;26(1):1923. doi: 10.1186/s12903-026-09869-0.
PubMed 42834376
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Two Desensitizing Agents Alone and In Combination on Dentin Permeability and Hypersensitivity
- ClinicalTrials.gov ID
- NCT04340869
- Acronym / sponsor ID
- REC18-145
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 10 Apr 2020 (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.
Treatment of Dentin Hypersensitivity Using Theobromine , Remin Pro , and Combination of Both Materials
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Theobromine | Experimental | Other: TheobromineNatural extract from Cocoa |
| Remin Pro | Active comparator | Other: Remin ProFluoride , Hydroxyapatite , and Xylitol |
| Combination | Experimental | Other: Theobromine, Other: Remin ProRemin Pro and Theobromine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients that aged 18-50 years.
- Patients in good general health.
- Patients that have accessible teeth demonstrating signs of sensitivity.
Key exclusion criteria (5 listed)
- • Any chronic debilitating disease that could influence study outcomes.
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 |
|---|---|---|
| TheobromineNatural extract from Cocoa | Other | Combination, Theobromine |
| Remin ProRemin Pro | Other | Combination, Remin Pro |
Primary outcome
Visual analogue scale pain score
Time frame: 1 month
0 = no pain to 10=severe exagerated pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Derived from this study: PubMed 42834376Kassab EE, Niazy MA, El Yasky MA, Ameen SM. Clinical effectiveness of theobromine, Remin Pro, and their combination in managing dentin hypersensitivity: a randomized clinical trial. BMC Oral Health. 2026 Oct 2;26(1):1923. doi: 10.1186/s12903-026-09869-0.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theobromine and Remin Pro in people with Dentin Sensitivity, 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebtsam Kassab (+201005889938, dentiebtsamkassab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale pain score (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04340869, which also lists 1 linked publication.
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 10 Apr 2020.