Please select the eligibility criteria that correspond 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: 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
B: Inclusion Criteria:

* Persons participating in the CAP-1 trial, who have received a pulp exposure due to treatment or due to absence of pain relief.

Exclusion Criteria:

* The CAP-1-treated tooth has ongoing unbearable pain and/or disturbed night sleep.
* Visible pus from the pulp.
C: Inclusion Criteria:

* Children with active caries without pulpal involvement in two deciduous molar teeth participated in the trial.
* The caries were located on the occlusal surface.

Exclusion Criteria:

* Children with pathological process of the dental tissue, with pulpal involvement
D: Inclusion Criteria:

* Children 3-9 yr
* Good general health
* Minimum one active deep (D3) occlusal/occlusal-proximal, one-/two-surface caries lesion

Exclusion Criteria:

* Participating in other study
* Plan to move or not resident
* Systemic disease or general disability
* Expected limited compliance
* Known allergy to study material expected exfoliation within 18 month

Answer: B