Dentine HypersensitivityNCT07056855
Three Different Topically Applied Materials as Non-invasive Treatment of Sensitivity in Permanent Teeth With Molar Incisor Hypomineralization
A study testing nano hydroxy apatite varnish Intervention (1), Potassium Nitrate Gel and Varnishes, Fluorid in people with Dentine Hypersensitivity, run by Cairo University.
Trial summary
This clinical study main goal is to investigate the effectiveness of nano hydroxy apatite crystal varnish and potassium nitrate gel as a non invasive approach in managing Dentin Hypersensitivity in MIH-affected teeth. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentine Hypersensitivity
- What is being tested?
- nano hydroxy apatite varnish Intervention (1), Potassium Nitrate Gel and Varnishes, Fluorid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2025to 20 Jul 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- Participants related criteria:
- Children with severe behavioral or emotional disabilities.
- Children who received analgesics within the last 24 hours before the procedure.
- Patients who are using chlorhexidine-based gels or mouthwashes.
- Tooth related criteria:
- A tooth with signs and symptoms of irreversible pulpitis.
Show all 10Show fewer
- A tooth with signs and symptoms of necrotic pulp.
- Sealing therapy or application of desensitizing agent on the MIH teeth within one month before participation in the study.
- Presence of dental caries on the MIH-affected permanent tooth.
- Presence of restoration(s) on MIH-affected permanent tooth.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mennat Allah A. A. Abd Elsabour, PhD student contact
About this study
Official title: Comparative Evaluation of Nano Hydroxy Apatite Varnish and Potassium Nitrate Gel Versus Fluoride Varnish as Non-invasive Treatment of Dentin Hypersensitivity in Permanent Teeth With Molar Incisor Hypo-mineralization: Randomized Clinical Trial
This clinical study main goal is to investigate the effectiveness of nano hydroxy apatite crystal varnish and potassium nitrate gel as a non invasive approach in managing Dentin Hypersensitivity in MIH-affected teeth.
Read the detailed description
This randomized clinical trial study aims to investigate the effectiveness of nano-hydroxy apatite crystal varnish, and potassium nitrate gel compared to fluoride varnish, in reducing dentin hypersensitivity, improving a child's oral hygiene.
- Conditions
- Dentine Hypersensitivity
- Being tested
- nano hydroxy apatite varnish Intervention (1), Potassium Nitrate Gel, Varnishes, Fluorid
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nano hydroxy apatite varnish Intervention (1)Drug
Fygg's professional strength, Fygg, USA
Potassium Nitrate GelDrug
Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USA
Varnishes, FluoridDrug
DentKist Charm Varnish 5% Sodium Fluoride Varnish
| Study group | Role | What they receive |
|---|---|---|
| 8.6% nano-hydroxy apatite crystals varnish (Fygg's professional strength, Fygg, USA). | Experimental | Intervention group (1) Receives: Drug: nano hydroxy apatite varnish Intervention (1) |
| Potassium Nitrate (Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USA). | Experimental | Intervention group (2) Receives: Drug: Potassium Nitrate Gel |
| 5% fluoride varnish Control group | Active comparator | Not described Receives: Drug: Varnishes, Fluorid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentin Hypersensitivity
Face scale: scores from 0-4. the higher the score the worse the sensitivity
Measured: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op
Dentin Hypersensitivity
chiff Cold Air Blasting Sensitivity Scale: scores from 0-3. The higher the score the worse the sensitivity.
Measured: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op
Secondary outcomes (1)
Oral hygiene
Measured by Plaque Control Record: Percentage.
Measured: baseline, 2-, and 4- week post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start10 Jul 2025 (estimated)
- Primary completion20 Jul 2025 (estimated)
- Study completion20 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentine HypersensitivityStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat Allah Ashraf Abd Elsabour Abd Elkareem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056855
- Sponsor's protocol ID
- 1444
- Status last verified
- Mar 2025
- First submitted
- 29 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Nano Hydroxy Apatite Varnish and Potassium Nitrate Gel Versus Fluoride Varnish as Non-invasive Treatment of Dentin Hypersensitivity in Permanent Teeth With Molar Incisor Hypo-mineralization: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07056855
- Acronym / sponsor ID
- 1444
- Conditions
- Dentine Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 20 Jul 2025 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 9 Jul 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.
This clinical study main goal is to investigate the effectiveness of nano hydroxy apatite crystal varnish and potassium nitrate gel as a non invasive approach in managing Dentin Hypersensitivity in MIH-affected teeth.
Detailed description
This randomized clinical trial study aims to investigate the effectiveness of nano-hydroxy apatite crystal varnish, and potassium nitrate gel compared to fluoride varnish, in reducing dentin hypersensitivity, improving a child's oral hygiene.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 8.6% nano-hydroxy apatite crystals varnish (Fygg's professional strength, Fygg, USA). | Experimental | Drug: nano hydroxy apatite varnish Intervention (1)Intervention group (1) |
| Potassium Nitrate (Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USA). | Experimental | Drug: Potassium Nitrate GelIntervention group (2) |
| 5% fluoride varnish Control group | Active comparator | Drug: Varnishes, Fluorid |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Children with severe behavioral or emotional disabilities.
- Children who received analgesics within the last 24 hours before the procedure.
- Patients who are using chlorhexidine-based gels or mouthwashes.
- A tooth with signs and symptoms of irreversible pulpitis.
- A tooth with signs and symptoms of necrotic pulp.
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 |
|---|---|---|
| nano hydroxy apatite varnish Intervention (1)Fygg's professional strength, Fygg, USA | Drug | 8.6% nano-hydroxy apatite crystals varnish (Fygg's professional strength, Fygg, USA). |
| Potassium Nitrate GelUltradent UltraEZ Desensitizing Gel, Ultradent Inc., USA | Drug | Potassium Nitrate (Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USA). |
| Varnishes, FluoridDentKist Charm Varnish 5% Sodium Fluoride Varnish | Drug | 5% fluoride varnish Control group |
Primary outcome
Dentin Hypersensitivity
Time frame: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op
Face scale: scores from 0-4. the higher the score the worse the sensitivity
Dentin Hypersensitivity
Time frame: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op
chiff Cold Air Blasting Sensitivity Scale: scores from 0-3. The higher the score the worse the sensitivity.
1 secondary outcome
Oral hygiene
Time frame: baseline, 2-, and 4- week post-op
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 9 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Mennat Allah A. A. Abd Elsabour, PhD student contact
Questions about this trial
What is this clinical trial studying?
A study testing nano hydroxy apatite varnish Intervention (1), Potassium Nitrate Gel and Varnishes, Fluorid in people with Dentine Hypersensitivity, run by Cairo University.
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 0 inclusion and 10 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 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Mennat Allah A. A. Abd Elsabour, PhD student (+201026022605, mennatallah.ashraf@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentin Hypersensitivity (time frame: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op). The study lists 2 primary outcomes in all. 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 9 Jul 2025.