Pulp Disease, DentalNCT05912907
Potassium Nitrate in Polycarboxylate as a Direct Pulp Capping
A study testing potassium nitrate in polycarboxilate cement in people with Pulp Disease, Dental, run by Minia University at 1 site in Egypt.
Trial summary
The study aimed to compare potassium nitrate in polycarboxylate cement to mineral trioxide aggregate as a direct pulp capping material of young permanent teeth in patients from 7 to 10 ears Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Disease, Dental
- What is being tested?
- potassium nitrate in polycarboxilate cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to Jul 2024
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 7-10 years of children
- Healthy children classified as ASA I or II
- Asymptomatic vital immature mandibular first molar with extensive and deep caries
- Signs and symptoms of reversible pulpitis
Who cannot join
- Necrotic teeth or teeth with irreversible pulpitis
- Medically compromised children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potassium Nitrate in Polycarboxylate Versus Mineral Trioxide Aggregate as a Direct Pulp Capping in Young Permanent Molars
The study aimed to compare potassium nitrate in polycarboxylate cement to mineral trioxide aggregate as a direct pulp capping material of young permanent teeth in patients from 7 to 10 ears
- Conditions
- Pulp Disease, Dental
- Being tested
- potassium nitrate in polycarboxilate cement
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
potassium nitrate in polycarboxilate cementOther
5% potassium nitrate in polycarboxylate; pre-weighed 95 mg zinc oxide powder and 5mg of KNO3 will be placed on a glass slab followed by mixing by polyacrylic acid (liquid) in a 1:1 P/L ratio
| Study group | Role | What they receive |
|---|---|---|
| potassium nitrate in polycarboxilate cement | Experimental | Not described Receives: Other: potassium nitrate in polycarboxilate cement |
| Mineral Trioxide Aggregate | Active comparator | Not described Receives: Other: potassium nitrate in polycarboxilate cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical success rate
Absence of pain, sensitivity to percussion, fistula or sinus tract, mobility
Measured: 24 months
Radiographic success rate
Absence of periapical radiolucency, internal root resorption, external root resorption
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jun 2022
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp Disease, DentalStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Elheeny, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912907
- Sponsor's protocol ID
- 532
- Status last verified
- Jun 2023
- First submitted
- 11 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potassium Nitrate in Polycarboxylate Versus Mineral Trioxide Aggregate as a Direct Pulp Capping in Young Permanent Molars
- ClinicalTrials.gov ID
- NCT05912907
- Acronym / sponsor ID
- 532
- Conditions
- Pulp Disease, Dental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 22 Jun 2023 (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 study aimed to compare potassium nitrate in polycarboxylate cement to mineral trioxide aggregate as a direct pulp capping material of young permanent teeth in patients from 7 to 10 ears
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| potassium nitrate in polycarboxilate cement | Experimental | Other: potassium nitrate in polycarboxilate cement |
| Mineral Trioxide Aggregate | Active comparator | Other: potassium nitrate in polycarboxilate cement |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 7-10 years of children
- Healthy children classified as ASA I or II
- Asymptomatic vital immature mandibular first molar with extensive and deep caries
- Signs and symptoms of reversible pulpitis
Key exclusion criteria (2 listed)
- Necrotic teeth or teeth with irreversible pulpitis
- Medically compromised children
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 |
|---|---|---|
| potassium nitrate in polycarboxilate cement5% potassium nitrate in polycarboxylate; pre-weighed 95 mg zinc oxide powder and 5mg of KNO3 will be placed on a glass slab followed by mixing by polyacrylic acid (liquid) in a 1:1 P/L ratio | Other | Mineral Trioxide Aggregate, potassium nitrate in polycarboxilate cement |
Primary outcome
clinical success rate
Time frame: 24 months
Absence of pain, sensitivity to percussion, fistula or sinus tract, mobility
Radiographic success rate
Time frame: 24 months
Absence of periapical radiolucency, internal root resorption, external root resorption
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing potassium nitrate in polycarboxilate cement in people with Pulp Disease, Dental, run by Minia 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 4 inclusion and 2 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 22 Jun 2023. 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?
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?
clinical success rate (time frame: 24 months). 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 22 Jun 2023; AzTrials last refreshed its copy on 28 Oct 2026.