Treatment of Deep Carious Lesions With Selective Caries Removal, Partial or Full Pulpotomy

NAUnknownINTERVENTIONAL
Enrollment

249

Participants

Timeline

Start Date

April 1, 2021

Primary Completion Date

September 30, 2022

Study Completion Date

September 30, 2025

Conditions
Irreversible PulpitisReversible PulpitisDentine Caries
Interventions
PROCEDURE

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)"

PROCEDURE

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)"

PROCEDURE

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)"

PROCEDURE

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"

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Septodont

INDUSTRY

collaborator

3M

INDUSTRY

lead

Charite University, Berlin, Germany

OTHER

NCT04807244 - Treatment of Deep Carious Lesions With Selective Caries Removal, Partial or Full Pulpotomy | Biotech Hunter | Biotech Hunter