Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04807244
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-03-19
First Post:
2021-03-11
Brief Title:
Treatment of Deep Carious Lesions With Selective Caries Removal Partial or Full Pulpotomy
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Randomized-controlled and Non-controlled Intervention Trial Treatment of Deep Carious Lesions in Permanent Molars
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Vitapulp
Brief 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
Detailed Description:
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
1 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
2 B1 Zahnärzte Clayallee 177 14195 Berlin Local principal investigator Dr Claus Schüttler-Janikulla
3 Endo Berlin Süd Alt-Buckow 9-11 12349 Berlin Local principal investigator ZÄ Olga Bleckmann
4 Dentalsplace Kurfürstendamm 22 Local principal investigator Dr Markus Lietzau MSc
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
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
1 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
2 B1 Zahnärzte Clayallee 177 14195 Berlin Local principal investigator Dr Claus Schüttler-Janikulla
3 Endo Berlin Süd Alt-Buckow 9-11 12349 Berlin Local principal investigator ZÄ Olga Bleckmann
4 Dentalsplace Kurfürstendamm 22 Local principal investigator Dr Markus Lietzau MSc
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None