Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187837
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2005-09-09
Brief Title:
The CAP-1 Trial Stepwise Excavation Versus One Completed Excavation in Deep Caries
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 11
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 ie 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 restorationHerculite
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 11
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 ie 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 restorationHerculite
Detailed Description:
References
BJERKÉN E WENNBERG A TRONSTAD L Endodontisk akutbehandling Tandläkartidningen 198072314-9
BJØRNDAL L REIT C The annual frequency of root-fillings tooth extractions and pulp related procedures in Danish adults 1977-2003 Int Endod J 200437782-788
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 199826122-8
BJØRNDAL L Treatment of deep carious lesions with stepwise excavation A practice-based study Tandlaegebladet 1999103498-506
BJØRNDAL L LARSEN T THYLSTRUP A A clinical and microbiological study of deep carious lesions during stepwise excavation using long treatment intervals Caries Res 199731411-
BJØRNDAL L LARSEN T Changes in the cultivable flora in deep carious lesions following a stepwise excavation procedure Caries Res 200034502-8
BERGENHOLTZ G SPÅNGBERG L Controversies in endodontics Crit Rev Oral Biol Med 20041599-114
FOUAD AF Molecular mediators of pulpal inflammation In Seltzer and Benders 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 199427100
KIRKEVANG L-L Periapical and endodontic status in Danish populations PhD 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 199612192-96
MAGNUSSON B SUNDELL SO Stepwise excavation of deep carious lesions in primary molars J Int Ass Child 1977836-40
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 ChichesterUk 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 199385543-6
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 198981856-67
SUDA H IKEDA H The circulation of the pulp In Seltzer and Benders 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
BJERKÉN E WENNBERG A TRONSTAD L Endodontisk akutbehandling Tandläkartidningen 198072314-9
BJØRNDAL L REIT C The annual frequency of root-fillings tooth extractions and pulp related procedures in Danish adults 1977-2003 Int Endod J 200437782-788
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 199826122-8
BJØRNDAL L Treatment of deep carious lesions with stepwise excavation A practice-based study Tandlaegebladet 1999103498-506
BJØRNDAL L LARSEN T THYLSTRUP A A clinical and microbiological study of deep carious lesions during stepwise excavation using long treatment intervals Caries Res 199731411-
BJØRNDAL L LARSEN T Changes in the cultivable flora in deep carious lesions following a stepwise excavation procedure Caries Res 200034502-8
BERGENHOLTZ G SPÅNGBERG L Controversies in endodontics Crit Rev Oral Biol Med 20041599-114
FOUAD AF Molecular mediators of pulpal inflammation In Seltzer and Benders 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 199427100
KIRKEVANG L-L Periapical and endodontic status in Danish populations PhD 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 199612192-96
MAGNUSSON B SUNDELL SO Stepwise excavation of deep carious lesions in primary molars J Int Ass Child 1977836-40
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 ChichesterUk 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 199385543-6
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 198981856-67
SUDA H IKEDA H The circulation of the pulp In Seltzer and Benders 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None