Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187850
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2005-09-13
Brief Title:
The CAP-2 Trial Effect of Direct Pulp Capping Versus Partial Pulpotomy
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
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
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:
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 1-15 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 andor 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 andor 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 11
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 ie 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
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 1-15 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 andor 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 andor 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 11
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 ie 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
Detailed Description:
None
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