Dental Pulp ExposureNCT00187850
The CAP-2 Trial: Effect of Direct Pulp Capping Versus Partial Pulpotomy
A study testing PP and DPC in people with Dental Pulp Exposure, run by University of Copenhagen at 1 site in Denmark.
Trial summary
CAP-2 Trial Background: This trial is being done in conjunction with an ongoing clinical trial investigating stepwise excavation versus final excavation on deep caries lesions (The CAP-1 trial). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Pulp Exposure
- What is being tested?
- PP and DPC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2005to Jun 2013
- 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
- Persons participating in the CAP-1 trial, who have received a pulp exposure due to treatment or due to absence of pain relief.
Who cannot join
- The CAP-1-treated tooth has ongoing unbearable pain and/or disturbed night sleep.
- Visible pus from the pulp.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The CAP-2 Trial: Effect of Direct Pulp Capping Versus Partial Pulpotomy on CAP-1 Patients: A Randomised, Patient - and Observer-Blinded Multicenter Trial
CAP-2 Trial
Background: This trial is being done in conjunction with an ongoing clinical trial investigating stepwise excavation versus final excavation on deep caries lesions (The CAP-1 trial). The investigators lack systematic knowledge concerning the treatment of the exposed pulp and whether the capping of a pulp represents the same outcome as the partial removal of an additional 1-1.5 mm of the pulp tissue (partial pulpotomy).
Read more
Aim: The aim of the CAP-2 trial is in a randomised clinical trial to investigate the effect of direct pulp capping versus partial pulpotomy in patients who, from the beginning, have received either a final excavation or a stepwise excavation and where this intervention has led to the exposure of a vital pulp and/or the patient has not gained relief from tooth pain after excavation and placement of a temporary restoration.
Patients: Patients include consecutive patients with deep caries who have been participating in the CAP-1 trial, where the pulp exposure to a bleeding pulp is present and/or pain relief has not been obtained.
Design: The CAP-2 trial is a randomised patient- and observer-blinded multicenter trial, with two parallel intervention groups. Patients who fulfill the inclusion criteria will be centrally bloc-randomised in the Copenhagen Trial Unit, Copenhagen DK, and stratified by age and pain. The allocation ratio is 1:1.
The Interventions and Products: Patients are allocated for direct pulp capping or partial pulpotomy. The patients will not be informed about the results of the randomisation, i.e. the type of intervention. In both groups the patient receives a calcium hydroxide seal covering the exposure and a glass ionomer restoration. The final resin restoration is placed following 4 weeks.
- Conditions
- Dental Pulp Exposure
- Being tested
- PP, DPC
- Keywords
- Pulp capping, partial pulpotomy, Exposure of the pulp
- Medical subject headings
- Dental Pulp Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPProcedure or surgery
Also called cvek´s pulpotomy
Partial pulpotomy
DPCProcedure or surgery
Direct pulp capping
| Study group | Role | What they receive |
|---|---|---|
| PP | Experimental | Partial pulpotomy Receives: Procedure: PP |
| DPC | Other | Direct pulp capping Receives: Procedure: DPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The survival of the tooth with vital pulp and without apical radiolucency. The x-ray evaluation and the clinical sensibility test are carried out by a blinded observer.
Measured: 1 year after inclusion in the CAP-2
Secondary outcomes (1)
Gain of pain relief
Measured: after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionMar 2007
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental Pulp ExposureStudies 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
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Insurance foundation, Dan Dental A/S, University of Aarhus, Göteborg University, Huddinge Faculty,Stockholm,Sweden, Uppsala FolkTandvård,Sweden, Malmö Dental school,Sweden
- Responsible party
- Principal investigator, Lars Bjørndal, University of Copenhagen
- Investigators
- Lars Bjørndal, Ph.D., Study director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187850
- Sponsor's protocol ID
- 10002
- Status last verified
- Oct 2016
- First submitted
- 13 Sep 2005
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bjorndal L, Reit C, Bruun G, Markvart M, Kjaeldgaard M, Nasman P, Thordrup M, Dige I, Nyvad B, Fransson H, Lager A, Ericson D, Petersson K, Olsson J, Santimano EM, Wennstrom A, Winkel P, Gluud C. Treatment of deep caries lesions in adults: randomized clinical trials comparing stepwise vs. direct complete excavation, and direct pulp capping vs. partial pulpotomy. Eur J Oral Sci. 2010 Jun;118(3):290-7. doi: 10.1111/j.1600-0722.2010.00731.x.
PubMed 20572864Bjorndal L, Fransson H, Bruun G, Markvart M, Kjaeldgaard M, Nasman P, Hedenbjork-Lager A, Dige I, Thordrup M. Randomized Clinical Trials on Deep Carious Lesions: 5-Year Follow-up. J Dent Res. 2017 Jul;96(7):747-753. doi: 10.1177/0022034517702620. Epub 2017 Apr 14.
PubMed 28410008
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CAP-2 Trial: Effect of Direct Pulp Capping Versus Partial Pulpotomy on CAP-1 Patients: A Randomised, Patient - and Observer-Blinded Multicenter Trial
- ClinicalTrials.gov ID
- NCT00187850
- Acronym / sponsor ID
- 10002
- Conditions
- Dental Pulp Exposure
- Keywords
- Pulp capping, partial pulpotomy, Exposure of the pulp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- National Health Insurance foundation, Dan Dental A/S, University of Aarhus, Göteborg University, Huddinge Faculty,Stockholm,Sweden, Uppsala FolkTandvård,Sweden, Malmö Dental school,Sweden
- Study start
- Feb 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Sep 2005 (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.
CAP-2 Trial
Background: This trial is being done in conjunction with an ongoing clinical trial investigating stepwise excavation versus final excavation on deep caries lesions (The CAP-1 trial). The investigators lack systematic knowledge concerning the treatment of the exposed pulp and whether the capping of a pulp represents the same outcome as the partial removal of an additional 1-1.5 mm of the pulp tissue (partial pulpotomy).
Aim: The aim of the CAP-2 trial is in a randomised clinical trial to investigate the effect of direct pulp capping versus partial pulpotomy in patients who, from the beginning, have received either a final excavation or a stepwise excavation and where this intervention has led to the exposure of a vital pulp and/or the patient has not gained relief from tooth pain after excavation and placement of a temporary restoration.
Patients: Patients include consecutive patients with deep caries who have been participating in the CAP-1 trial, where the pulp exposure to a bleeding pulp is present and/or pain relief has not been obtained.
Design: The CAP-2 trial is a randomised patient- and observer-blinded multicenter trial, with two parallel intervention groups. Patients who fulfill the inclusion criteria will be centrally bloc-randomised in the Copenhagen Trial Unit, Copenhagen DK, and stratified by age and pain. The allocation ratio is 1:1.
The Interventions and Products: Patients are allocated for direct pulp capping or partial pulpotomy. The patients will not be informed about the results of the randomisation, i.e. the type of intervention. In both groups the patient receives a calcium hydroxide seal covering the exposure and a glass ionomer restoration. The final resin restoration is placed following 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PP | Experimental | Procedure: PPPartial pulpotomy |
| DPC | Other | Procedure: DPCDirect pulp capping |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persons participating in the CAP-1 trial, who have received a pulp exposure due to treatment or due to absence of pain relief.
Key exclusion criteria (2 listed)
- The CAP-1-treated tooth has ongoing unbearable pain and/or disturbed night sleep.
- Visible pus from the 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 |
|---|---|---|
| PPAlso: cvek´s pulpotomyPartial pulpotomy | Procedure or surgery | PP |
| DPCDirect pulp capping | Procedure or surgery | DPC |
Primary outcome
The survival of the tooth with vital pulp and without apical radiolucency. The x-ray evaluation and the clinical sensibility test are carried out by a blinded observer.
Time frame: 1 year after inclusion in the CAP-2
1 secondary outcome
Gain of pain relief
Time frame: after 4 weeks
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 18 Oct 2016.
- Background: PubMed 20572864Bjorndal L, Reit C, Bruun G, Markvart M, Kjaeldgaard M, Nasman P, Thordrup M, Dige I, Nyvad B, Fransson H, Lager A, Ericson D, Petersson K, Olsson J, Santimano EM, Wennstrom A, Winkel P, Gluud C. Treatment of deep caries lesions in adults: randomized clinical trials comparing stepwise vs. direct complete excavation, and direct pulp capping vs. partial pulpotomy. Eur J Oral Sci. 2010 Jun;118(3):290-7. doi: 10.1111/j.1600-0722.2010.00731.x.
- Derived from this study: PubMed 28410008Bjorndal L, Fransson H, Bruun G, Markvart M, Kjaeldgaard M, Nasman P, Hedenbjork-Lager A, Dige I, Thordrup M. Randomized Clinical Trials on Deep Carious Lesions: 5-Year Follow-up. J Dent Res. 2017 Jul;96(7):747-753. doi: 10.1177/0022034517702620. Epub 2017 Apr 14.
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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.
Lars Bjørndal, Ph.D. study director
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PP and DPC in people with Dental Pulp Exposure, run by University of Copenhagen at 1 site in Denmark.
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 2 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 18 Oct 2016. 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 Denmark. 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?
The survival of the tooth with vital pulp and without apical radiolucency. The x-ray evaluation and the clinical sensibility test are carried out by a blinded observer. (time frame: 1 year after inclusion in the CAP-2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00187850, which also lists 2 linked publications.
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 18 Oct 2016.