Irreversible PulpitisNCT02920606
Pulpotomy as a Treatment of Irreversible Pulpitis
A study testing Pulpotomy and Endodontic treatment in people with Irreversible Pulpitis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Trial summary
The procedure currently recommended for the treatment of irreversible pulpitis is the endodontic treatment, i.e. the complete elimination of the pulp, disinfection and obturation of the whole root canal system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Pulpotomy and Endodontic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Good general health
- Not pregnant women
- At least one permanent molar in irreversible pulpitis
- Adult patient
- Mentally competent
Who cannot join
- Periapical radiolucency
- Periodontical probing
- Root fracture
- Sinus tract
- Swelling or mobility
- External or/and internal resorption
- Open apicies
- A non restorable tooth
About this study
Official title: Pulpotomy as a Permanent Treatment of Irreversible Pulpitis on Mature Molar Teeth - a Pilot Study
The procedure currently recommended for the treatment of irreversible pulpitis is the endodontic treatment, i.e. the complete elimination of the pulp, disinfection and obturation of the whole root canal system. The emergency procedure consists of a pulpotomy, followed at an ulterior appointment by the root canal treatment. The purpose of the present pilot study is to evaluate the feasibility of performing the pulpotomy as a permanent treatment in mature molars. If hemostasis can be achieved after removing the coronal part of the pulp, a tricalcium silicate cement will be directly applied on the remaining pulp at the root canal entrances. A short-term follow-up will be performed at one week by evaluating the pain relief of the patient. Long-term success will then be evaluated every year by verifying the absence of periapical radiolucency on the x-ray as well as the absence of clinical symptoms and signs. A standard root canal procedure will serve as control. During the pulpotomy treatment, blood sample with microcapillary will be performed. We will analyze a ratio of pro-inflammatory and anti-inflammatory cytokines.
- Conditions
- Irreversible Pulpitis
- Being tested
- Pulpotomy, Endodontic treatment
- Keywords
- pulpotomy, pulpitis, mature tooth, tricalcium silicate
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
Endodontic treatmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Endodontic treatment | Active comparator | The patient will benefit from a conventional treatment : a root canal treatment.
The root canal treatment consists of removing the pulp tissue from all the canals, disinfecting the root canal system with sodium hypochlorite and filling the root with a root canal sealer and gutta percha. Receives: Procedure: Endodontic treatment |
| Pulpotomy | Experimental | The patient will benefit from an experimental treatment : a pulpotomy. The pulpotomy aims at removing the coronal part of the pulp (the pulp present in the pulp chamber) and filling the pulp chamber with a bioactive material. Receives: Procedure: Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the success rate (%) at 1 year
to evaluate the treatment success defined as the absence of clinical symptoms (pain, sinus tract..) and the absence of radiological symptoms (periapical radiolucency), in order to point the non-inferiority of the pulpotomy compared with the conventional treatment
Measured: Follow up at 1 year for all patients included in the study
Secondary outcomes (1)
Evaluation of the correlation between pro/anti-inflammatory cytokines and the success of pulpotomy
During the pulpotomy treatment, blood samples with microcapillaries will be performed. We will analyze a ratio of pro-inflammatory and anti-inflammatory cytokines.
Measured: Follow up at 1 year for all patients included in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2021 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julian G Leprince, Professor, Study chair, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920606
- Sponsor's protocol ID
- Pulpotomie-1
- Status last verified
- Mar 2021
- First submitted
- 30 May 2016
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulpotomy as a Permanent Treatment of Irreversible Pulpitis on Mature Molar Teeth - a Pilot Study
- ClinicalTrials.gov ID
- NCT02920606
- Acronym / sponsor ID
- Pulpotomie-1
- Conditions
- Irreversible Pulpitis
- Keywords
- pulpotomy, pulpitis, mature tooth, tricalcium silicate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 30 Sep 2016 (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 procedure currently recommended for the treatment of irreversible pulpitis is the endodontic treatment, i.e. the complete elimination of the pulp, disinfection and obturation of the whole root canal system. The emergency procedure consists of a pulpotomy, followed at an ulterior appointment by the root canal treatment. The purpose of the present pilot study is to evaluate the feasibility of performing the pulpotomy as a permanent treatment in mature molars. If hemostasis can be achieved after removing the coronal part of the pulp, a tricalcium silicate cement will be directly applied on the remaining pulp at the root canal entrances. A short-term follow-up will be performed at one week by evaluating the pain relief of the patient. Long-term success will then be evaluated every year by verifying the absence of periapical radiolucency on the x-ray as well as the absence of clinical symptoms and signs. A standard root canal procedure will serve as control. During the pulpotomy treatment, blood sample with microcapillary will be performed. We will analyze a ratio of pro-inflammatory and anti-inflammatory cytokines.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endodontic treatment | Active comparator | Procedure: Endodontic treatmentThe patient will benefit from a conventional treatment : a root canal treatment. The root canal treatment consists of removing the pulp tissue from all the canals, disinfecting the root canal system with sodium hypochlorite and filling the root with a root canal sealer and gutta percha. |
| Pulpotomy | Experimental | Procedure: PulpotomyThe patient will benefit from an experimental treatment : a pulpotomy. The pulpotomy aims at removing the coronal part of the pulp (the pulp present in the pulp chamber) and filling the pulp chamber with a bioactive material. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Good general health
- Not pregnant women
- At least one permanent molar in irreversible pulpitis
- Adult patient
- Mentally competent
Key exclusion criteria (8 listed)
- Periapical radiolucency
- Periodontical probing
- Root fracture
- Sinus tract
- Swelling or mobility
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 |
|---|---|---|
| Pulpotomy | Procedure or surgery | Pulpotomy |
| Endodontic treatment | Procedure or surgery | Endodontic treatment |
Primary outcome
Evaluation of the success rate (%) at 1 year
Time frame: Follow up at 1 year for all patients included in the study
to evaluate the treatment success defined as the absence of clinical symptoms (pain, sinus tract..) and the absence of radiological symptoms (periapical radiolucency), in order to point the non-inferiority of the pulpotomy compared with the conventional treatment
1 secondary outcome
Evaluation of the correlation between pro/anti-inflammatory cytokines and the success of pulpotomy
Time frame: Follow up at 1 year for all patients included in the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Irreversible Pulpitis
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Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
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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.
Julian G Leprince, Professor study chair
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Questions about this trial
What is this clinical trial studying?
A study testing Pulpotomy and Endodontic treatment in people with Irreversible Pulpitis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
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 8 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 11 Mar 2021. 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?
Evaluation of the success rate (%) at 1 year (time frame: Follow up at 1 year for all patients included in the study). 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 11 Mar 2021.