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.