Deep Dental CariesNCT02201498
Randomized Clinical Trial for Primary Molar Pulpotomy, Biodentine Vs Formocresol-ZOE
A study testing Pulpotomies with Formocresol/OZE and Biodentine in people with Deep Dental Caries, run by Université de Montréal at 1 site in Canada.
Trial summary
This is a RCT that will compare the clinical and radiographic success of pulpotomies on primary molars between the traditional technique (Formocresol/ZOE) and the new technique with Biodentine. 180 pulpotomies (90 in each group) will be followed for a period of 12 months. Read more about this study
- Who is it for?
- Ages Up to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Dental Caries
- What is being tested?
- Pulpotomies with Formocresol/OZE and Biodentine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Jun 2016
- 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 Up to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA I and II
- less than 1/3 of physiologic root resorption
- asymptomatic tooth (with no history of symptoms)
- no clinical or radiological sign of pathology
- vital tooth, with carious pulpal exposure
- hemostasis must be obtained simply with pressure in less than 5 min
- teeth restored with stainless steel crowns
Who cannot join
- more than 10 y.o.
- symptomatic tooth (presently or history of symptoms)
- previous pulpal treatment on the tooth
- necrotic pulp
- hyperemic pulp
- inadequate operative technique, defective restauration
- non diagnostic x-ray (pre or post treatment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A New Technique for Primary Molar Pulpotomy : A Randomized Clinical Trial Comparing the Radiographic and Clinical Success of the Formocresol-zinc Oxide Eugenol Technique and the Biodentine Technique
This is a RCT that will compare the clinical and radiographic success of pulpotomies on primary molars between the traditional technique (Formocresol/ZOE) and the new technique with Biodentine. 180 pulpotomies (90 in each group) will be followed for a period of 12 months.
- Conditions
- Deep Dental Caries
- Being tested
- Pulpotomies with Formocresol/OZE and Biodentine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulpotomies with Formocresol/OZE and BiodentineProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Formocresol/OZE | Active comparator | Conventional pulpotomy technique, with formocresol and zinc oxide eugenol Receives: Procedure: Pulpotomies with Formocresol/OZE and Biodentine |
| Biodentine | Active comparator | New technique, with biodentine Receives: Procedure: Pulpotomies with Formocresol/OZE and Biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical success
Measured: 12 months post treatment
radiographic success
Measured: 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Dental CariesStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Septodont, St. Justine's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201498
- Sponsor's protocol ID
- BIODENT1
- Status last verified
- Jan 2018
- First submitted
- 24 Jul 2014
- Last updated
- 12 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Technique for Primary Molar Pulpotomy : A Randomized Clinical Trial Comparing the Radiographic and Clinical Success of the Formocresol-zinc Oxide Eugenol Technique and the Biodentine Technique
- ClinicalTrials.gov ID
- NCT02201498
- Acronym / sponsor ID
- BIODENT1
- Conditions
- Deep Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Septodont, St. Justine's Hospital
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Jul 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.
This is a RCT that will compare the clinical and radiographic success of pulpotomies on primary molars between the traditional technique (Formocresol/ZOE) and the new technique with Biodentine. 180 pulpotomies (90 in each group) will be followed for a period of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formocresol/OZE | Active comparator | Procedure: Pulpotomies with Formocresol/OZE and BiodentineConventional pulpotomy technique, with formocresol and zinc oxide eugenol |
| Biodentine | Active comparator | Procedure: Pulpotomies with Formocresol/OZE and BiodentineNew technique, with biodentine |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- ASA I and II
- less than 1/3 of physiologic root resorption
- asymptomatic tooth (with no history of symptoms)
- no clinical or radiological sign of pathology
- vital tooth, with carious pulpal exposure
Key exclusion criteria (7 listed)
- more than 10 y.o.
- symptomatic tooth (presently or history of symptoms)
- previous pulpal treatment on the tooth
- necrotic pulp
- hyperemic pulp
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 |
|---|---|---|
| Pulpotomies with Formocresol/OZE and Biodentine | Procedure or surgery | Biodentine, Formocresol/OZE |
Primary outcome
clinical success
Time frame: 12 months post treatment
radiographic success
Time frame: 12 months post treatment
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 12 Jan 2018.
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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 Pulpotomies with Formocresol/OZE and Biodentine in people with Deep Dental Caries, run by Université de Montréal at 1 site in Canada.
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 7 inclusion and 7 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 12 Jan 2018. 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 Canada. 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 success (time frame: 12 months post treatment). 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 12 Jan 2018.