Dental CariesNCT00187837
The CAP-1 Trial: Stepwise Excavation Versus One Completed Excavation in Deep Caries
A study testing SW and DCE in people with Dental Caries and Reversible Pulpitis, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Brief summary Background: A large proportion of dental practice involves the treatment of caries in the permanent dentition. In USA alone tooth related pain is annually responsible for 15 billions days lost through sickness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Caries, Reversible Pulpitis
- What is being tested?
- SW and DCE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 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
- Person ≥ 18 yrs having deep caries with or without pain:
- x-ray show primary caries in the inner 1/4 of the dentin, with the presence of a radiopaque zone at the pulpal wall NB: Need to mark a 'yes' for both criteria!
Who cannot join
- Deep carious tooth with (irreversible pulpitis)unbearable pain and/or disturbed night's sleep)
- Deep carious tooth negatively responding on thermal and electrometric tests.
- Deep carious tooth has 'attachment loss' > 5 mm
- X-ray shows apical radiolucency of the actual tooth
- Deep carious tooth has restoration in direct contact with the pulp
- The person has problems with communication
Show all 9Show fewer
- No informed and written consent is present
- Due to health conditions or pregnancy the person can not participate in the trial
- NB: Need to mark 'No' for all criteria
Trial locations and contacts
1 site in 1 country.
Denmark1 site
School of Dentistry, Faculty of Health Sciences
Copenhagen, Copenhagen N, 2200
About this study
Official title: The CAP-1 Trial: Effect of Stepwise Versus One Completed Excavation in Deep Caries in Permanent Teeth: A Randomised, Patient - and Observer-blinded Multicenter Trial
Brief summary
Background:
Read more
A large proportion of dental practice involves the treatment of caries in the permanent dentition. In USA alone tooth related pain is annually responsible for 15 billions days lost through sickness. We do not know whether a stepwise excavation is better or worse compared with one final completed excavation in adults with deep caries with or without pain. A deep carious lesion is in the risk zone of being pulpal exposed during excavation.
Aim:
The aim of the CAP-1-trial is to investigate the beneficial effects of stepwise excavation during two visits versus óne completed excavation of deep caries in permanent teeth with or without pain.
Patients:
Consecutive patients contacting the units involved in the CAP trial for the treatment of deep caries. The trial will comprise 300 patients.
Design:
CAP-1-trial is a randomised patient- and observer-blinded multicenter trial, with two parallel intervention groups. Patients that fulfill the inclusions criteria and none of the exclusions criteria, will be centrally bloc-randomised in Copenhagen Trial Unit, Copenhagen DK, and stratified by age and pain. Allocation ratio is 1:1.
Interventions and products:
Patients are allocated for stepwise excavation in two visits or final excavation in one visit. The patients will not be informed about the result of the randomisation, i.e. the type of intervention. Therefore, all patients will be contacted for two visits. The second visit in the stepwise excavation group wil be used for the second and final excavation, and for the performance of a permanent restoration. The second visit in the one step excavation group will solely be used for the performance of a permanent restoration. The interventions in both groups are completed following 8-10 weeks after the randomisation.
A temporary calcium hydroxide based material is used in both groups (Dycal®). The temporary restoration material, glas-ionomer cement is used (Ketac Molar®) in between visits, and a resin material is used for the final restoration(Herculite®).
Read the detailed description
References
BJERKÉN E, WENNBERG A, TRONSTAD L. Endodontisk akutbehandling. Tandläkartidningen. 1980;72:314-9.
BJØRNDAL L, REIT C. The annual frequency of root-fillings, tooth extractions and pulp related procedures in Danish adults 1977-2003. Int Endod J 2004:37:782-788.
BJØRNDAL L. The deep caries lesion dilemma. In Nordic Dentistry 2004 yearbook (Schou L, ed). Copenhagen, Denmark: Quintessence Publishing Co, Inc., 2004; 107-20.
BJØRNDAL L \& THYLSTRUP A. A practice -based study on stepwise excavation of deep carious lesions in permanent teeth: a 1-year follow-up study. Community Dent Oral Epidemiol 1998;26:122-8.
BJØRNDAL L. Treatment of deep carious lesions with stepwise excavation. A practice-based study. Tandlaegebladet 1999;103:498-506.
BJØRNDAL L, LARSEN T, THYLSTRUP A. A clinical and microbiological study of deep carious lesions during stepwise excavation using long treatment intervals. Caries Res 1997;31:411-.
BJØRNDAL L, LARSEN T. Changes in the cultivable flora in deep carious lesions following a stepwise excavation procedure. Caries Res 2000;34:502-8.
BERGENHOLTZ G, SPÅNGBERG L. Controversies in endodontics. Crit Rev Oral Biol Med 2004;15:99-114.
FOUAD AF. Molecular mediators of pulpal inflammation. In Seltzer and Bender's Dental pulp ( Hargreaves KM, Goodis HE, eds). Chicago, USA: Quintessence Publishing Co, Inc., 2002; 247-79.
KARLSSON P-O, REIT C. Reasons for endodontic treatment among Swedish general practitioners (abstract). Int Endod J 1994;27:100.
KIRKEVANG L-L Periapical and endodontic status in Danish populations (Ph.D: thesis). Århus: University of Aarhus; 2001.
LEKSELL E, RIDELL K, CVEK M, MEJÁRE I. Pulp exposure after stepwise versus direct complete excavation of deep carious lesions in young posterior permanent teeth. Endod Dent Traumatol 1996;12:192-96.
MAGNUSSON B, SUNDELL SO. Stepwise excavation of deep carious lesions in primary molars. J Int Ass Child 1977;8:36-40.
NADIN G, GOEL BR, YEUNG Ca, GLENNY AM. Pulp treatment for extensive decay in primary teeth (Cochrane Review). In: The Cochrane Library, Issue 1, 2004. Chichester,Uk: John Wiley \& Sons, Ltd.
NÄRHI M. Dentinal and pulpal pain. In Textbook of Endodontology (Bergenholtz G, Hørsted-Bindslev P, Reit C, eds). Oxford, UK: Blackwell Munksgaard, 2003; 43-56.
REIT C, HEDEN G, MILTHON R. Endodontiskt behandlingspanorama inom allmäntandvården. Tandläkartidningen 1993;85:543-6.
RICKETTS DNJ, KIDD EAM, INNES N. Complete or ultraconservative removal of decayed tissue in unfilled teeth (Protocol for a Cochrane Review). In: The Cochrane Libray, Issue 1, 2004. Chichester , UK: John Wiley \& Sons, Ltd.
SJÖSTRÖM O, SUNDBERG H. Arbetstidens fördelning på olika verksamheter i svensk tandvård 1988. Tandläkartidningen 1989;81:856-67.
SUDA H, IKEDA H. The circulation of the pulp. In Seltzer and Bender's Dental pulp (Hargreaves KM, Goodis HE, eds). Chicago, USA: Quintessence Publishing Co, Inc., 2002; 123-50.
TAYLOR H, CURRAN NM. The Nuprin Pain Report. New York, Lou Harris, 1985.
- Conditions
- Dental Caries, Reversible Pulpitis
- Being tested
- SW, DCE
- Keywords
- Stepwise excavation
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWProcedure or surgery
Also called Stepwise carious removal wos
Stepwise removal of carious tissue in 2 stages
DCEProcedure or surgery
Also called Non-selective carious removal to hard dentin
one complete excavation
| Study group | Role | What they receive |
|---|---|---|
| SW intervention | Experimental | Stepwise Excavation Receives: Procedure: SW |
| DCE intervention | Other | Control intervention Direct complete excavation. The updated terminology for completed excavation is non-selective excavation to hard dentin Receives: Procedure: DCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is whether the treatment can be made with a maintained sensible pulp and without root infection following a 1-year control.
In this update we have also completed 5 yr control
Measured: 1year control data for all treatments primo 2008
Secondary outcomes (1)
Secondary outcome constitutes pain intensity using a visual analogue scale measured before the first visit and 1 and 7 days after.
Measured: ultimo 2007
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 CariesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 314 participants (actual)
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, Study director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187837
- Sponsor's protocol ID
- 10001
- Status last verified
- Oct 2016
- First submitted
- 9 Sep 2005
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 1½ yr results published in European Journal of Oral Sciences 2010; 118: 290-297.
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-1 Trial: Effect of Stepwise Versus One Completed Excavation in Deep Caries in Permanent Teeth: A Randomised, Patient - and Observer-blinded Multicenter Trial
- ClinicalTrials.gov ID
- NCT00187837
- Acronym / sponsor ID
- 10001
- Conditions
- Dental Caries, Reversible Pulpitis
- Keywords
- Stepwise excavation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- 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.
Brief summary
Background:
A large proportion of dental practice involves the treatment of caries in the permanent dentition. In USA alone tooth related pain is annually responsible for 15 billions days lost through sickness. We do not know whether a stepwise excavation is better or worse compared with one final completed excavation in adults with deep caries with or without pain. A deep carious lesion is in the risk zone of being pulpal exposed during excavation.
Aim:
The aim of the CAP-1-trial is to investigate the beneficial effects of stepwise excavation during two visits versus óne completed excavation of deep caries in permanent teeth with or without pain.
Patients:
Consecutive patients contacting the units involved in the CAP trial for the treatment of deep caries. The trial will comprise 300 patients.
Design:
CAP-1-trial is a randomised patient- and observer-blinded multicenter trial, with two parallel intervention groups. Patients that fulfill the inclusions criteria and none of the exclusions criteria, will be centrally bloc-randomised in Copenhagen Trial Unit, Copenhagen DK, and stratified by age and pain. Allocation ratio is 1:1.
Interventions and products:
Patients are allocated for stepwise excavation in two visits or final excavation in one visit. The patients will not be informed about the result of the randomisation, i.e. the type of intervention. Therefore, all patients will be contacted for two visits. The second visit in the stepwise excavation group wil be used for the second and final excavation, and for the performance of a permanent restoration. The second visit in the one step excavation group will solely be used for the performance of a permanent restoration. The interventions in both groups are completed following 8-10 weeks after the randomisation.
A temporary calcium hydroxide based material is used in both groups (Dycal®). The temporary restoration material, glas-ionomer cement is used (Ketac Molar®) in between visits, and a resin material is used for the final restoration(Herculite®).
Detailed description
References
BJERKÉN E, WENNBERG A, TRONSTAD L. Endodontisk akutbehandling. Tandläkartidningen. 1980;72:314-9.
BJØRNDAL L, REIT C. The annual frequency of root-fillings, tooth extractions and pulp related procedures in Danish adults 1977-2003. Int Endod J 2004:37:782-788.
BJØRNDAL L. The deep caries lesion dilemma. In Nordic Dentistry 2004 yearbook (Schou L, ed). Copenhagen, Denmark: Quintessence Publishing Co, Inc., 2004; 107-20.
BJØRNDAL L \& THYLSTRUP A. A practice -based study on stepwise excavation of deep carious lesions in permanent teeth: a 1-year follow-up study. Community Dent Oral Epidemiol 1998;26:122-8.
BJØRNDAL L. Treatment of deep carious lesions with stepwise excavation. A practice-based study. Tandlaegebladet 1999;103:498-506.
BJØRNDAL L, LARSEN T, THYLSTRUP A. A clinical and microbiological study of deep carious lesions during stepwise excavation using long treatment intervals. Caries Res 1997;31:411-.
BJØRNDAL L, LARSEN T. Changes in the cultivable flora in deep carious lesions following a stepwise excavation procedure. Caries Res 2000;34:502-8.
BERGENHOLTZ G, SPÅNGBERG L. Controversies in endodontics. Crit Rev Oral Biol Med 2004;15:99-114.
FOUAD AF. Molecular mediators of pulpal inflammation. In Seltzer and Bender's Dental pulp ( Hargreaves KM, Goodis HE, eds). Chicago, USA: Quintessence Publishing Co, Inc., 2002; 247-79.
KARLSSON P-O, REIT C. Reasons for endodontic treatment among Swedish general practitioners (abstract). Int Endod J 1994;27:100.
KIRKEVANG L-L Periapical and endodontic status in Danish populations (Ph.D: thesis). Århus: University of Aarhus; 2001.
LEKSELL E, RIDELL K, CVEK M, MEJÁRE I. Pulp exposure after stepwise versus direct complete excavation of deep carious lesions in young posterior permanent teeth. Endod Dent Traumatol 1996;12:192-96.
MAGNUSSON B, SUNDELL SO. Stepwise excavation of deep carious lesions in primary molars. J Int Ass Child 1977;8:36-40.
NADIN G, GOEL BR, YEUNG Ca, GLENNY AM. Pulp treatment for extensive decay in primary teeth (Cochrane Review). In: The Cochrane Library, Issue 1, 2004. Chichester,Uk: John Wiley \& Sons, Ltd.
NÄRHI M. Dentinal and pulpal pain. In Textbook of Endodontology (Bergenholtz G, Hørsted-Bindslev P, Reit C, eds). Oxford, UK: Blackwell Munksgaard, 2003; 43-56.
REIT C, HEDEN G, MILTHON R. Endodontiskt behandlingspanorama inom allmäntandvården. Tandläkartidningen 1993;85:543-6.
RICKETTS DNJ, KIDD EAM, INNES N. Complete or ultraconservative removal of decayed tissue in unfilled teeth (Protocol for a Cochrane Review). In: The Cochrane Libray, Issue 1, 2004. Chichester , UK: John Wiley \& Sons, Ltd.
SJÖSTRÖM O, SUNDBERG H. Arbetstidens fördelning på olika verksamheter i svensk tandvård 1988. Tandläkartidningen 1989;81:856-67.
SUDA H, IKEDA H. The circulation of the pulp. In Seltzer and Bender's Dental pulp (Hargreaves KM, Goodis HE, eds). Chicago, USA: Quintessence Publishing Co, Inc., 2002; 123-50.
TAYLOR H, CURRAN NM. The Nuprin Pain Report. New York, Lou Harris, 1985.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SW intervention | Experimental | Procedure: SWStepwise Excavation |
| DCE intervention | Other | Procedure: DCEControl intervention Direct complete excavation. The updated terminology for completed excavation is non-selective excavation to hard dentin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Person ≥ 18 yrs having deep caries with or without pain:
- x-ray show primary caries in the inner 1/4 of the dentin, with the presence of a radiopaque zone at the pulpal wall NB: Need to mark a 'yes' for both criteria!
Key exclusion criteria (9 listed)
- Deep carious tooth with (irreversible pulpitis)unbearable pain and/or disturbed night's sleep)
- Deep carious tooth negatively responding on thermal and electrometric tests.
- Deep carious tooth has 'attachment loss' > 5 mm
- X-ray shows apical radiolucency of the actual tooth
- Deep carious tooth has restoration in direct contact with 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 |
|---|---|---|
| SWAlso: Stepwise carious removal wosStepwise removal of carious tissue in 2 stages | Procedure or surgery | SW intervention |
| DCEAlso: Non-selective carious removal to hard dentinone complete excavation | Procedure or surgery | DCE intervention |
Primary outcome
Primary outcome is whether the treatment can be made with a maintained sensible pulp and without root infection following a 1-year control.
Time frame: 1year control data for all treatments primo 2008
In this update we have also completed 5 yr control
1 secondary outcome
Secondary outcome constitutes pain intensity using a visual analogue scale measured before the first visit and 1 and 7 days after.
Time frame: ultimo 2007
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.
- Results publication: 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.
- Individual participant dataSharing planned: Yes. 1½ yr results published in European Journal of Oral Sciences 2010; 118: 290-297.
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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 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 SW and DCE in people with Dental Caries and Reversible Pulpitis, 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 2 inclusion and 9 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?
Primary outcome is whether the treatment can be made with a maintained sensible pulp and without root infection following a 1-year control. (time frame: 1year control data for all treatments primo 2008). 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 NCT00187837, 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.