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

Summary

The optimal treatment of deep caries lesions extended to the inner third of dentin is still under discussion. Cariologists prefer selective caries removal, meanwhile endodontists recommend partial pulpotomy. So far, no clinical trial compared both interventions against each other. Additionally, current literature indicates alternative treatment options for irreversible pulpitis besides conventional orthograde root canal treatments like the partial or full pulpotomy. Existing clinical studies on this topic were using different clinical protocols, especially with regards to the accepted time to achieve hemostasis. It is still unclear, if the pulpal bleeding time prior to the capping procedure affects the outcome of partial or full pulpotomy.

Conditions

• Irreversible Pulpitis
• Reversible Pulpitis
• Dentine 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

• Septodont

  collaborator INDUSTRY

• 3M

  collaborator INDUSTRY

• Charite University, Berlin, Germany

  lead OTHER

Principal Investigators

• Falk Schwendicke, Prof. · Charite University, Berlin, Germany

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2022-09-30

Completion

2025-09-30