Please select the arm or intervention descriptions that belong to the clinical trial below.
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
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 1-1.5 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.


Options:
A: Arm Label: intervention; Type: EXPERIMENTAL; Interventions: Device: self assembling peptide P11-4 (Curodont™ Repair), Device: fluoride varnish (Duraphat®) | Arm Label: control; Type: ACTIVE_COMPARATOR; Interventions: Device: fluoride varnish (Duraphat®) | Intervention Type: DEVICE; Name: self assembling peptide P11-4 (Curodont™ Repair); Assigned to Arm(s): intervention | Intervention Type: DEVICE; Name: fluoride varnish (Duraphat®); Assigned to Arm(s): control, intervention
B: Arm Label: PP; Type: EXPERIMENTAL; Interventions: Procedure: PP | Arm Label: DPC; Type: OTHER; Interventions: Procedure: DPC | Intervention Type: PROCEDURE; Name: PP; Assigned to Arm(s): PP | Intervention Type: PROCEDURE; Name: DPC; Assigned to Arm(s): DPC
C: Arm Label: CHEMOMECHANICAL CARIES REMOVAL; Type: EXPERIMENTAL; Interventions: Procedure: Chemomechanical Caries Removal | Arm Label: conventional method; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Conventional method | Intervention Type: PROCEDURE; Name: Chemomechanical Caries Removal; Assigned to Arm(s): CHEMOMECHANICAL CARIES REMOVAL | Intervention Type: PROCEDURE; Name: Conventional method; Assigned to Arm(s): conventional method
D: Arm Label: Selective removal; Type: EXPERIMENTAL; Interventions: Procedure: Selective removal | Arm Label: Stepwise removal; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Stepwise removal | Intervention Type: PROCEDURE; Name: Selective removal; Assigned to Arm(s): Selective removal | Intervention Type: PROCEDURE; Name: Stepwise removal; Assigned to Arm(s): Stepwise removal

Answer: B