Effects of Partical Excavation in One Versus Two Procedures of Primary Deep Caries (PAPRICA) (PAPRICA)
Primary Dental Caries
About this trial
This is an interventional treatment trial for Primary Dental Caries focused on measuring Partial excavation, Deep dentin caries, RCT
Eligibility Criteria
Inclusion Criteria:
- Adults and children >9 years.
- Primary coronal caries without pain in a permanent tooth (pain is accepted when evoked by a hot, cold, or sweet stimulus of short duration and disappears when the stimulus is removed).
- The radiograph shows caries within the pulpal ¼ of the dentine with the presence of a radiodense zone separating the pulp from the demineralised dentine.
- No exposure of the pulp following the first excavation.
- Available for recall at 1 and 3 years.
- Written informed consent.
Exclusion Criteria:
- Actual deep carious tooth presenting spontaneous and/or prolonged pain within the last 6 months, or pain causing disturbed night sleep.
- Actual deep carious tooth with negative thermal and/or electrical pulp test.
- Radiograph shows apical or radicular radiolucency of the tooth.
- Deep carious tooth has restoration in close contact with pulp.
- No written informed consent.
Sites / Locations
- PDHS - Bornholm
- PDHS - Gentofte
- University of Copenhagen
- PDHS - Copenhagen municipality
- PDHS - Randers municipality
- PDHS - Hørsholm
- PDHS - Aarhus municipality
- PDHS - Brøndby
- University of Norway - Lithuania
- Preventive Dentistry Department
- Malmo University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Partial caries excavation (1 step)
Partial caries excavation (2 steps)
Patients with radiographical caries within the pulpal ¼ of the dentine with the presence of a radiodense zone separating the pulp from the demineralised dentine is candidates for the treatment. Local anaesthesia shall be used. as this procedure is identical for the two interventions tested in this trial. A partial removal of carious dentine is performed with superficial removal of the outermost infected and necrotic part of the demineralised dentine. Intervention: A permanent resin restoration is placed on top of the remained caries.
Patients with radiographical caries within the pulpal ¼ of the dentine with the presence of a radiodense zone separating the pulp from the demineralised dentine is candidates for the treatment. Before randomisation, the participants receive the first excavation procedure as this procedure is identical for the two interventions tested in this trial. A partial removal of carious dentine is performed with superficial removal of the outermost infected and necrotic part of the demineralised dentine. Intervention: After randomisation, a calcium hydroxide containing base material is used and a temporary glass-ionomer restoration is placed in the entire cavity. After 4-6 months, the temporary restoration is removed, final excavation is carried out with hand excavators until firm but stained dentine remains, and a permanent resin restoration is placed.