Pulp Disease, DentalNCT06170762
Sodiumhexametaphosphate Versus MTA as Pulp Capping Material for Immature Permanent Teeth
A study testing Pulp capping, Sodiumhexametaphosphate and MTA in people with Pulp Disease, Dental, run by Minia University.
Trial summary
Sodiumhexametaphosphate will be used as capping material for dental pulp of immature permanent teeth Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Pulp Disease, Dental
- What is being tested?
- Pulp capping, Sodiumhexametaphosphate and MTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2023to 20 Jan 2025
- 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 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- healthy children
- cooperative children
- deep carious lesion
- traumatic pulp exposure
- immature permanent teeth
Who cannot join
- uncooperative children
- children with systemic disorders
- non vital immature permanent teeth
About this study
Official title: Sodiumhexametaphosphate Versus MTA as Pulp Capping Material for Immature Permanent Teeth ( Randomized Clinical Trial)
Sodiumhexametaphosphate will be used as capping material for dental pulp of immature permanent teeth
- Conditions
- Pulp Disease, Dental
- Being tested
- Pulp capping, Sodiumhexametaphosphate, MTA
- 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.
Pulp cappingOther
Pulp capping material for immature permanent teeth in case of carious or traumatic pulp expures
SodiumhexametaphosphateDrug
Sodiumhexametaphosphate
MTAOther
MTA
| Study group | Role | What they receive |
|---|---|---|
| Sodiumhexametaphosphate | Experimental | Not described Receives: Other: Pulp capping; Drug: Sodiumhexametaphosphate |
| MTA | Active comparator | Not described Receives: Other: Pulp capping; Other: MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
Absence of pain, tenderness, mobility and swelling
Measured: One year
Radiographic success
Absence of periapical lesions, internal resorption an external resorption also evidence of continuous root growth
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start20 Dec 2023 (estimated)
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Jan 2025 (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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Mahmoud, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170762
- Sponsor's protocol ID
- 800
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodiumhexametaphosphate Versus MTA as Pulp Capping Material for Immature Permanent Teeth ( Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06170762
- Acronym / sponsor ID
- 800
- Conditions
- Pulp Disease, Dental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 14 Dec 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.
Sodiumhexametaphosphate will be used as capping material for dental pulp of immature permanent teeth
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodiumhexametaphosphate | Experimental | Other: Pulp capping, Drug: Sodiumhexametaphosphate |
| MTA | Active comparator | Other: Pulp capping, Other: MTA |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- healthy children
- cooperative children
- deep carious lesion
- traumatic pulp exposure
- immature permanent teeth
Key exclusion criteria (3 listed)
- uncooperative children
- children with systemic disorders
- non vital immature permanent teeth
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 |
|---|---|---|
| Pulp cappingPulp capping material for immature permanent teeth in case of carious or traumatic pulp expures | Other | MTA, Sodiumhexametaphosphate |
| SodiumhexametaphosphateSodiumhexametaphosphate | Drug | Sodiumhexametaphosphate |
| MTAMTA | Other | MTA |
Primary outcome
Clinical success
Time frame: One year
Absence of pain, tenderness, mobility and swelling
Radiographic success
Time frame: One year
Absence of periapical lesions, internal resorption an external resorption also evidence of continuous root growth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 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.
Questions about this trial
What is this clinical trial studying?
A study testing Pulp capping, Sodiumhexametaphosphate and MTA in people with Pulp Disease, Dental, run by Minia 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 5 inclusion and 3 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 14 Dec 2023. 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?
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 (time frame: One year). 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 14 Dec 2023.