249
Participants
Start Date
April 1, 2021
Primary Completion Date
September 30, 2022
Study Completion Date
September 30, 2025
Selective Caries Removal with Biodentine™
"1. Rubber dam placement~2. Cleaning of the tooth and rubber dam with ethanol 98%~3. Caries removal: Removal of protruding parts of enamel/dentin with high-speed round bur with continuous water cooling, caries removal with a low-speed round bur; peripheral caries is removed until only hard dentin is left, while the pulp wall is excavated until reaching leathery dentin~4. Disinfection of the leathery dentin 5 ml 1% NaOCl (speed: 1 ml per min)~5. Indirect pulp capping (layer of 1-2 mm) of the carious lesion with Biodentine™ (15 min setting time after mixing)"
Partial Pulpotomy with Biodentine™
"1. Rubber dam placement~2. Cleaning of the tooth and rubber dam with ethanol 98%~3. Caries removal: Removal of protruding parts of enamel/dentin with high-speed round bur with continuous water cooling, caries removal with a low-speed round bur; before accessing the pulp chamber, the central caries will be left, peripheral caries will be excavated completely~4. Disinfection of the leathery dentin 5 ml NaOCl 1% (speed: 1 ml per min)~5. Accessing the pulp chamber with a high-speed round bur and removal of 2-3 mm pulp tissue; irrigation with 2 ml NaOCl 1%~6. Hemostasis will be achieved with a sterile foam pellet soaked with NaOCl 1% with gentle pressure to the pulp for 3 min~7. If hemostasis could not be achieved within 3 min, step 6 will be repeated once. In case of no hemostasis, transfer of the case to Intervention: full pulpotomy with Biodentine~8. Confirmed hemostasis: pulp capping with Biodentine™ (layer min. 2-3 mm, 15 min setting time after mixing)"
Full Pulpotomy with Biodentine™
"1. Rubber dam placement~2. Cleaning of the tooth and rubber dam with ethanol 98%~3. Caries removal: Removal of protruding parts of enamel/dentin with high-speed round bur with continuous water cooling, caries removal with a low-speed round bur; before accessing the pulp chamber, the central caries will be left, peripheral caries will be excavated completely~4. Disinfection of the leathery dentin 5 ml NaOCl 1% (speed: 1 ml per min)~5. Accessing the pulp chamber with a high-speed round bur and removal of the entire pulp chamber roof; full pulpotomy to stump level with a high-speed round bur under continuous irrigation with 5 ml NaOCl 1%~6. Hemostasis will be achieved with a sterile foam pellet soaked with NaOCl 1% with gentle pressure to the pulp for 3 min~7. If hemostasis could not be achieved within 3 min, step 6 will be repeated once. In case of no hemostasis, exclusion.~8. Confirmed hemostasis: pulp capping with Biodentine™ (layer min. 2-3 mm, 15 min setting time after mixing)"
Direct composite filling after selective caries removal/full pulpotomy/partial pulpotomy
"1. Dentin cleaning with a low-speed round bur~2. Use of Scotchbond Universal™ and Filtek Supreme XTE™ according to manufacturer's recommendation"
Collaborators (1)
Septodont
INDUSTRY
3M
INDUSTRY
Charite University, Berlin, Germany
OTHER