PulpitisPhase 4NCT02286648
Success Rate Evaluation of Miniature Pulpotomy With MTA in Primary Molars
A Phase 4 study testing Formocresol and Mineral Trioxide Aggregate in people with Pulpitis and Dental Pulp Disease, run by Mashhad University of Medical Sciences at 2 sites in Iran.
Trial summary
The purpose of this study is to evaluate the clinical and radiographic success rate of Miniature pulpotomy with Mineral Trioxide Aggregate (MTA) in primary molars. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis, Dental Pulp Disease, Tooth Diseases
- What is being tested?
- Formocresol and Mineral Trioxide Aggregate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesIran
- Study dates
- Feb 2014to Jul 2015
- Phase
- Phase 4
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy people(without any systemic disease)
- teeth :
- no clinical or radiographic evidence of pulp degeneration
- the possibility of proper restoration of the teeth
Who cannot join
- teeth :
- excessive bleeding from the exposure site
- internal root resorption
- interradicular and/or periapical bone destruction
- swelling or sinus tract
Trial locations and contacts
2 sites in 1 country.
Iran2 sites, 2 recruiting
- Recruiting
Mashhad University of Medical Siences
Mashhad, Razavi Khorasan Province, 9185769516
Hossein Nematollahi, associate of professor
Homa Noorollahian, associate of professor
- Recruiting
Mashhad University of Medical Siences
Mashhad, Razavi Khorasan Province, 9185769516
Hossein Nematollahi, associate of professor
Homa Noorollahian, associate of professor
About this study
The purpose of this study is to evaluate the clinical and radiographic success rate of Miniature pulpotomy with Mineral Trioxide Aggregate (MTA) in primary molars.
- Conditions
- Pulpitis, Dental Pulp Disease, Tooth Diseases
- Being tested
- Formocresol, Mineral Trioxide Aggregate
- Keywords
- clinical signs, child, pulpotomy
- Medical subject headings
- Pulpitis, Dental Pulp Diseases, Tooth Diseases, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FormocresolDrug
pulpotomy with formocresol
Mineral Trioxide AggregateDrug
pulpotomy with MTA
| Study group | Role | What they receive |
|---|---|---|
| Mineral Trioxide Aggregate | Experimental | pulpotomy with MTA Receives: Drug: Mineral Trioxide Aggregate |
| Formocresol | Active comparator | pulpotomy with FC Receives: Drug: Formocresol |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful outcome of treatment as indicated by clinical signs defined with observation and check list
success or failure of treatment defined with observation and check list
Measured: up to 12 months
Secondary outcomes (1)
successful outcome of treatment as indicated by radiographic signs defined with observation and check list
success or failure of treatment defined with observation and check list
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpitisStudies 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 4
- 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
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossein Nematollahi, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286648
- Sponsor's protocol ID
- 921762
- Status last verified
- Nov 2014
- First submitted
- 25 Apr 2014
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success Rate Evaluation of Miniature Pulpotomy With MTA in Primary Molars
- ClinicalTrials.gov ID
- NCT02286648
- Acronym / sponsor ID
- 921762
- Conditions
- Pulpitis, Dental Pulp Disease, Tooth Diseases
- Keywords
- clinical signs, child, pulpotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2015 (estimated)
- First posted
- 10 Nov 2014 (estimated)
- 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 purpose of this study is to evaluate the clinical and radiographic success rate of Miniature pulpotomy with Mineral Trioxide Aggregate (MTA) in primary molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mineral Trioxide Aggregate | Experimental | Drug: Mineral Trioxide Aggregatepulpotomy with MTA |
| Formocresol | Active comparator | Drug: Formocresolpulpotomy with FC |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- healthy people(without any systemic disease)
- teeth :
Key exclusion criteria (5 listed)
- 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 |
|---|---|---|
| Formocresolpulpotomy with formocresol | Drug | Formocresol |
| Mineral Trioxide Aggregatepulpotomy with MTA | Drug | Mineral Trioxide Aggregate |
Primary outcome
successful outcome of treatment as indicated by clinical signs defined with observation and check list
Time frame: up to 12 months
success or failure of treatment defined with observation and check list
1 secondary outcome
successful outcome of treatment as indicated by radiographic signs defined with observation and check list
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2014.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Formocresol and Mineral Trioxide Aggregate in people with Pulpitis and Dental Pulp Disease, run by Mashhad University of Medical Sciences at 2 sites in Iran.
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 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 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hossein Nematollahi, associate prof. (+989151141688, nematollahih@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful outcome of treatment as indicated by clinical signs defined with observation and check list (time frame: up to 12 months). 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 10 Nov 2014.