Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* children aged between 5 and 10 years
* cooperative behavior
* presenting good health conditions
* whose parents or legal guardians accept and sign the consent form
* with at least one occluso-proximal lesion in primary molar
* only occlusal-proximal surfaces with caries lesions with dentin involvement
* cavities accessible to hand instruments used in ART
* absence of fistula or abscess near the selected tooth
* absence of pulp exposure in the selected tooth
* absence of mobility in the selected tooth
* cavity size in the selected tooth not be bigger than 2.0 mm in the mesial-distal and 2.5 in the occlusal-cervical and bucco-lingual directions.

Exclusion Criteria:

* children younger than 5 years and older than 10
* non-cooperative behavior
* without good health conditions
* whose parents or legal guardians did not accepted and signed the consent form
* without any occluso-proximal lesion in primary molar
* caries in the selected tooth reaching other surfaces (than occlusal-proximal surface)
* occlusal-proximal surface with caries without dentin involvement
* cavities not accessible to hand instruments
* fistula or abscess near the selected tooth
* pulp exposure in the selected tooth
* mobility in the selected tooth
* cavity size bigger than 2.0 mm in the mesial-distal and 2.5 in the occlusal-cervical and - bucco-lingual directions.
B: Inclusion Criteria:

* 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!

Exclusion Criteria:

* 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
* 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
C: Inclusion Criteria:

* Early occlusal carious lesions (without cavity) on permanent molar "6" or "7" at eruption which does not require an invasive treatment
* Age ≥ 5 years
* Size and form of the lesions: the lesions must both be fully visible and assessable and accessible
* Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study
* Written informed consent before participation in the study

Exclusion Criteria:

* Evidence of tooth erosion
* Fluoride varnish application \< 3 months prior to study treatment
* History of head and neck illnesses (e.g. head/neck cancer)
* Any pathology or concomitant medication affecting salivary flow or dry mouth
* Any metabolic disorders affecting bone turnover
* Concurrent participation in another clinical trial
D: Inclusion Criteria:

* To have at least one ICDAS 3 lesion in first permanent molars
* To be systemically healthy

Exclusion Criteria:

* Not fully erupted first molars
* Structural defects in first molars, i.e., hypoplasia, fluorosis, MIH.
* Periodontal disease
* Orthodontic appliances
* Medication use

Answer: B