Dental Pulp CappingNCT02620826
Prospective Comparison of Indirect Pulp Therapy and Mineral Trioxide Aggregate Pulpotomy in Decayed Primary Molars
A study testing Indirect pulp therapy and Pulpotomy in people with Dental Pulp Capping, run by University of Michigan at 1 site in United States.
Trial summary
This prospective study compares the use of indirect pulp therapy and mineral trioxide aggregate pulpotomy for pulp therapy of the primary molar with dental caries approaching the pulp. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Capping
- What is being tested?
- Indirect pulp therapy and Pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2019
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child with at least one primary molar with deep decay approaching the pulp.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This prospective study compares the use of indirect pulp therapy and mineral trioxide aggregate pulpotomy for pulp therapy of the primary molar with dental caries approaching the pulp.
- Conditions
- Dental Pulp Capping
- Being tested
- Indirect pulp therapy, Pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect pulp therapyProcedure or surgery
Decayed dentin is lined with a resin-modified glass ionomer (Vitrebond Plus)
PulpotomyProcedure or surgery
A cervical pulpotomy is done and the radicular pulp is lined with Mineral Trioxide Aggregate
| Study group | Role | What they receive |
|---|---|---|
| Indirect pulp therapy | Experimental | Primary molars will be treated with indirect pulp therapy using resin-modified glass ionomer (Vitrebond Plus). Receives: Procedure: Indirect pulp therapy |
| Pulpotomy | Active comparator | Primary molars treated with MTA pulpotomy. Receives: Procedure: Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of pulp vitality
Pain, mobility, abscess as determined with clinical evaluation
Measured: 10 years
Secondary outcomes (1)
Radiographic assessment of pulp vitality
Signs of pulpal degeneration, including evaluation for presence or absence of internal/external root resorption, periodontal ligament widening, and intraradicular radiolucency as determined with radiographic evaluation
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startDec 2013
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp CappingStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James R. Boynton, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620826
- Sponsor's protocol ID
- 00077025
- Status last verified
- Feb 2024
- First submitted
- 28 Jan 2015
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Indirect Pulp Therapy and Mineral Trioxide Aggregate Pulpotomy in Decayed Primary Molars
- ClinicalTrials.gov ID
- NCT02620826
- Acronym / sponsor ID
- 00077025
- Conditions
- Dental Pulp Capping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 3 Dec 2015 (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.
This prospective study compares the use of indirect pulp therapy and mineral trioxide aggregate pulpotomy for pulp therapy of the primary molar with dental caries approaching the pulp.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indirect pulp therapy | Experimental | Procedure: Indirect pulp therapyPrimary molars will be treated with indirect pulp therapy using resin-modified glass ionomer (Vitrebond Plus). |
| Pulpotomy | Active comparator | Procedure: PulpotomyPrimary molars treated with MTA pulpotomy. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child with at least one primary molar with deep decay approaching the pulp.
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 |
|---|---|---|
| Indirect pulp therapyDecayed dentin is lined with a resin-modified glass ionomer (Vitrebond Plus) | Procedure or surgery | Indirect pulp therapy |
| PulpotomyA cervical pulpotomy is done and the radicular pulp is lined with Mineral Trioxide Aggregate | Procedure or surgery | Pulpotomy |
Primary outcome
Clinical assessment of pulp vitality
Time frame: 10 years
Pain, mobility, abscess as determined with clinical evaluation
1 secondary outcome
Radiographic assessment of pulp vitality
Time frame: 10 years
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 Feb 2024.
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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 Indirect pulp therapy and Pulpotomy in people with Dental Pulp Capping, run by University of Michigan at 1 site in United States.
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 1 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 Feb 2024. 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 United States. 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?
Clinical assessment of pulp vitality (time frame: 10 years). 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 Feb 2024.