Please select the arm or intervention descriptions that belong to the clinical trial below.
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: 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®).


Options:
A: Arm Label: Atraumatic Restorative Treatment; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Atraumatic Restorative Treatment | Arm Label: Hall Technique; Type: EXPERIMENTAL; Interventions: Procedure: Hall Technique | Intervention Type: PROCEDURE; Name: Atraumatic Restorative Treatment; Assigned to Arm(s): Atraumatic Restorative Treatment | Intervention Type: PROCEDURE; Name: Hall Technique; Assigned to Arm(s): Hall Technique
B: Arm Label: SW intervention; Type: EXPERIMENTAL; Interventions: Procedure: SW | Arm Label: DCE intervention; Type: OTHER; Interventions: Procedure: DCE | Intervention Type: PROCEDURE; Name: SW; Assigned to Arm(s): SW intervention | Intervention Type: PROCEDURE; Name: DCE; Assigned to Arm(s): DCE intervention
C: 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
D: Arm Label: Glass Ionomer Sealant; Type: EXPERIMENTAL; Interventions: Drug: Sealants to arrest microcavitated caries. | Arm Label: Resin Sealant; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sealants to arrest microcavitated caries. | Intervention Type: DRUG; Name: Sealants to arrest microcavitated caries.; Assigned to Arm(s): Glass Ionomer Sealant, Resin Sealant

Answer: B