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

Randomized-controlled and Non-controlled Intervention Trial: Treatment of Deep Carious Lesions in Permanent Molars

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.

Goals of the study In consequence, the investigators aim to proof the effectiveness of different therapies and protocols in two study arms, depending on the initial diagnosis: Arm A: Randomized-controlled clinical non-inferiority trial: Teeth with reversible pulpitis will be included accordingly to the inclusion criteria (see below). After randomization, teeth will be treated either with selective caries removal (indirect pulp capping) or partial pulpotomy pursuant to the below described clinical protocol. The intention of this study arm is to evaluate both therapies. Arm B: Prospective non-controlled clinical intervention trial Teeth with reversible pulpitis according to the inclusion criteria (see below) will be included. Depending on the clinical situation, a partial or full pulpotomy will be conducted accordingly to the defined clinical protocols (see below). In this study arm, the investigators want to evaluate 1) different times of pulpal bleeding before pulp capping and 2) partial versus full pulpotomy on the clinical outcome in teeth with irreversible pulpitis. Primary hypothesis: There is no statistically significant difference in the clinical success (absence of any clinical symptoms and signs of inflammation) between both treatments. Secondary hypothesis: There is no statistically significant difference in the radiographical success (absence of any pathosis) between both treatments. Duration of the study: The study is estimated to complete enrollment within 18 months from study initiation. In cases of unforeseeable events, enrollment will remain open until the study goal is met. For each subject, participation will be a maximum of three years. Products intended use All products the investigators intend to use are registered medicine products and well established on the market: • Biodentine™ (Septodont, Saint-Maur-des-Fossés, France): Biodentine™ is a hydraulic calcium silicate cement (HSC), which is commonly used for vital pulp therapy in both, children and adults. Many clinical trials were successfully conducted with this material. Compared to other HSC, the effect of tooth staining is much less likely and the clinical perfomance is comparable to other HSC. The main advantage of Biodentine™ compared to other HSC is, that Biodentine™ needs only 15 min for setting up, other HSC show significantly longer settings times. Septodont recommends using a self-etch adhesive in combination with Biodentine™. • Scotchbond Universal™ and Filtek Supreme XTE™ Scotchbond Universal™ is a self-etch adhesive and Filtek Supreme XTE™ is a universal restorative material for direct restorations (3M, Saint Paul, Minnesota, USA). Both materials are commercially available since many years and approved in several clinical trials. Product acquisition Biodentine™, Scotchbond Universal™ and Filtek Supreme XTE™ will be sponsored by the manufacturer. All other materials of routine use will be purchased by the centers. Potential benefits and risks to patients Every effort is taken during all treatments to minimize the risks to the patients. The primary goal of arms A and B is to evaluate three well established interventions. In consequence, the investigators expect no higher risks to the patients compared to routine treatments in our clinic. The benefit in participating for the patient is, that the investigators offer minimally invasive interventions for lower costs than usual. In cases of failure, the investigators follow our protocol as described in "failure management". Methods: Study design: Single-blind multi-center study with two arms involving two hundred and forty-nine (249) subjects undergoing a deep caries therapy. Four dental clinics with board certified endodontists contribute to this study in terms of patient recruitment and treatment. The centers are: Charité - Universitätsmedizin Berlin, Department for Oral Diagnostics, Digital Health and Health Services Research, Aßmannshauser Str. 4-6, 14197 Berlin Local principal investigator and study leader: Dr. Sascha Herbst B1 Zahnärzte, Clayallee 177, 14195 Berlin Local principal investigator: Dr. Claus Schüttler-Janikulla Endo Berlin Süd, Alt-Buckow 9-11, 12349 Berlin Local principal investigator: ZÄ Olga Bleckmann Dentalsplace, Kurfürstendamm 22 Local principal investigator: Dr. Markus Lietzau, M.Sc. Every patient has to give informed consent for participating in one of both study arms. To avoid clustering, only one tooth per patient can be included. Arm A is designed as a randomized-controlled and arm B as a non-controlled intervention trial. The intervention in study arm B will be conducted adapted to the clinical findings after entering slightly the pulp chamber. Depending on the pulpal bleeding time, either a partial pulpotomy or a full pulpotomy will be conducted, according to the predefined protocol mentioned in "treatment protocol for arm A". Due to the experimental design, only single blinding of the patient is feasible.

Every patient has to give informed consent for participating in one of both study arms. To avoid clustering, only one tooth per patient can be included. Arm A is designed as a randomized-controlled and arm B as a non-controlled intervention trial. The intervention in study arm B will be conducted adapted to the clinical findings after entering slightly the pulp chamber. Depending on the pulpal bleeding time, either a partial pulpotomy or a full pulpotomy will be conducted, according to the predefined protocol mentioned in "treatment protocol for arm A". Due to the experimental design, only single blinding of the patient is feasible.

Teeth with reversible pulpitis will be included accordingly to the inclusion criteria (see below). After randomization, teeth will be treated either with selective caries removal (indirect pulp capping) or partial pulpotomy pursuant to the below described clinical protocol. The intention of this study arm is to evaluate both therapies.

Teeth with reversible pulpitis according to the inclusion criteria (see below) will be included. Depending on the clinical situation, a partial or full pulpotomy will be conducted accordingly to the defined clinical protocols (see below). In this study arm, we want to evaluate 1) different times of pulpal bleeding before pulp capping and 2) partial versus full pulpotomy on the clinical outcome in teeth with irreversible pulpitis.

Rubber dam placement Cleaning of the tooth and rubber dam with ethanol 98% 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 Disinfection of the leathery dentin 5 ml 1% NaOCl (speed: 1 ml per min) Indirect pulp capping (layer of 1-2 mm) of the carious lesion with Biodentine™ (15 min setting time after mixing)

Rubber dam placement Cleaning of the tooth and rubber dam with ethanol 98% 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 Disinfection of the leathery dentin 5 ml NaOCl 1% (speed: 1 ml per min) Accessing the pulp chamber with a high-speed round bur and removal of 2-3 mm pulp tissue; irrigation with 2 ml NaOCl 1% Hemostasis will be achieved with a sterile foam pellet soaked with NaOCl 1% with gentle pressure to the pulp for 3 min 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" Confirmed hemostasis: pulp capping with Biodentine™ (layer min. 2-3 mm, 15 min setting time after mixing)

Rubber dam placement Cleaning of the tooth and rubber dam with ethanol 98% 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 Disinfection of the leathery dentin 5 ml NaOCl 1% (speed: 1 ml per min) 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% Hemostasis will be achieved with a sterile foam pellet soaked with NaOCl 1% with gentle pressure to the pulp for 3 min If hemostasis could not be achieved within 3 min, step 6 will be repeated once. In case of no hemostasis, exclusion. Confirmed hemostasis: pulp capping with Biodentine™ (layer min. 2-3 mm, 15 min setting time after mixing)

Dentin cleaning with a low-speed round bur Use of Scotchbond Universal™ and Filtek Supreme XTE™ according to manufacturer's recommendation

Palpation testing with a finger and little pressure (tenderness to palpation or no tenderness to palpation)

Percussion testing of the treated tooth: backside of dental mirror (tenderness to percussion or no tenderness to percussion)

Inclusion Criteria: Age > 18 a Health status No contributory systemic diseases with influence to the immune system or coagulation system Tooth-related factors Type: Permanent molars Mature roots Caries extended to >2/3 of dentin and expected pulp exposure performing non-selective caries removal (Only study arm "partial pulpotomy": Pulp exposure after non-selective caries removal) Sensibility: +/++; prolonged <5s Pain only on stimulus (hot/cold) and not prolonged or no pain No tenderness to palpation No tenderness to percussion Periodontal probing depth <4 mm No pathologic tooth mobility No swelling No fistula No swelling Radiograph: Periapical status with physiological appearance (PAI Score I or II) No partial/full crown restauration Tooth has to be restorable Pulpal diagnosis reversible pulpitis Exclusion Criteria: Age < 18 a Health status with above mentioned contributory diseases (immunosuppression, or diseases related to the coagulation system) Deciduous teeth Immature roots Caries extending less than <2/3 of dentin (Only study arm "partial pulpotomy": No pulp exposure after non-selective caries removal) Tooth sensibility +++ or prolonged > 5 s Severe pain, prolonged on stimulus (hot/cold), dull, throbbing, spontaneous pain Tenderness to palpation + Periodontal probing depth >3 mm Tooth mobility grade >Score I Swelling present Fistula present Radiograph: Apical periodontitis or apical rarefaction Partial or full crown restauration in situ Tooth is non-restorable Diagnosis: Irreversible pulpitis

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