Pulpotomies Primary TeethNCT01962077
Comparison of MedCem MTA and Formocresol Used in Pulpotomies in Primary Teeth.
A study testing MedCem MTA pulpotomies in primary teeth. in people with Pulpotomies Primary Teeth and Effectiveness of MedCem MTA® in Pulpotomies Primary Teeth, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
assess the effect of MedCem MTA as a pulp medicament following pulpotomy in human primary molars with carious pulp exposure in comparison to Formocresol. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomies Primary Teeth, Effectiveness of MedCem MTA® in Pulpotomies Primary Teeth
- What is being tested?
- MedCem MTA pulpotomies in primary teeth.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2013to Jun 2021
- 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 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy children
- with Asymptomatic primary molars with a deep carious lesion;
- Exposure of a vital pulp by caries;
- No clinical or radiographic evidence of pulp degeneration, such as excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction,swelling, or sinus tract;
- Ability to perform a leakage free restoration of the teeth using stainless steel crown, or amalgam/resin based restoration.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of MedCem MTA and Formocresol Used in Pulpotomies in Primary Teeth
assess the effect of MedCem MTA as a pulp medicament following pulpotomy in human primary molars with carious pulp exposure in comparison to Formocresol.
- Being tested
- MedCem MTA pulpotomies in primary teeth.
- Keywords
- pulpotomy, MTA, primary teeth, formocresol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedCem MTA pulpotomies in primary teeth.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| MedCem MTA pulpotomies | Experimental | Not described Receives: Procedure: MedCem MTA pulpotomies in primary teeth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of MedCem MTA pulpotomy in primary molar
No pain, no swelling or sinus tract, no internal root resorption progressing into the bone, no furcation and/or periapical bond destruction.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpotomies Primary TeethStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962077
- Sponsor's protocol ID
- Nathalie- HMO-CTIL
- Status last verified
- Jun 2021
- First submitted
- 25 Sep 2013
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of MedCem MTA and Formocresol Used in Pulpotomies in Primary Teeth
- ClinicalTrials.gov ID
- NCT01962077
- Acronym / sponsor ID
- Nathalie- HMO-CTIL
- Keywords
- pulpotomy, MTA, primary teeth, formocresol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 14 Oct 2013 (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.
assess the effect of MedCem MTA as a pulp medicament following pulpotomy in human primary molars with carious pulp exposure in comparison to Formocresol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MedCem MTA pulpotomies | Experimental | Procedure: MedCem MTA pulpotomies in primary teeth. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- healthy children
- with Asymptomatic primary molars with a deep carious lesion;
- Exposure of a vital pulp by caries;
- No clinical or radiographic evidence of pulp degeneration, such as excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction,swelling, or sinus tract;
- Ability to perform a leakage free restoration of the teeth using stainless steel crown, or amalgam/resin based restoration.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MedCem MTA pulpotomies in primary teeth. | Procedure or surgery | MedCem MTA pulpotomies |
Primary outcome
Success of MedCem MTA pulpotomy in primary molar
Time frame: Up to 36 months
No pain, no swelling or sinus tract, no internal root resorption progressing into the bone, no furcation and/or periapical bond destruction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
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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 MedCem MTA pulpotomies in primary teeth. in people with Pulpotomies Primary Teeth and Effectiveness of MedCem MTA® in Pulpotomies Primary Teeth, run by Hadassah Medical Organization at 1 site in Israel.
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 0 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: finished, as of the sponsor's last update on 6 Jul 2021. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Success of MedCem MTA pulpotomy in primary molar (time frame: Up to 36 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 6 Jul 2021.