Irreversible PulpitisVitapulpNCT04807244
Treatment of Deep Carious Lesions With Selective Caries Removal, Partial or Full Pulpotomy
A study testing Selective Caries Removal with Biodentine™, Partial Pulpotomy with Biodentine™ and Full Pulpotomy with Biodentine™ in people with Irreversible Pulpitis and Reversible Pulpitis, run by Charite University, Berlin, Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis, Reversible Pulpitis, Dentine Caries
- What is being tested?
- Selective Caries Removal with Biodentine™, Partial Pulpotomy with Biodentine™ and Full Pulpotomy with Biodentine™
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 19Show fewer
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Irreversible Pulpitis, Reversible Pulpitis, Dentine Caries
- Being tested
- Selective Caries Removal with Biodentine™, Partial Pulpotomy with Biodentine™, Full Pulpotomy with Biodentine™, Direct composite filling after selective caries removal/full pulpotomy/partial pulpotomy
- Keywords
- Partial Pulpotomy, Full Pulpotomy, Selective Caries Removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Caries Removal with Biodentine™Procedure or surgery
- 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)
Partial Pulpotomy with Biodentine™Procedure or surgery
- 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)
Full Pulpotomy with Biodentine™Procedure or surgery
- 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)
Direct composite filling after selective caries removal/full pulpotomy/partial pulpotomyProcedure or surgery
- Dentin cleaning with a low-speed round bur
- Use of Scotchbond Universal™ and Filtek Supreme XTE™ according to manufacturer's recommendation
| Study group | Role | What they receive |
|---|---|---|
| Treatment of deep carious lesions: Randomized-controlled trail | Other | 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. Receives: Procedure: Selective Caries Removal with Biodentine™; Procedure: Partial Pulpotomy with Biodentine™; Procedure: Direct composite filling after selective caries removal/full pulpotomy/partial pulpotomy |
| Treatment of deep carious lesions: Prospective non-controlled intervention trial | Other | 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. Receives: Procedure: Full Pulpotomy with Biodentine™; Procedure: Direct composite filling after selective caries removal/full pulpotomy/partial pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with positive reaction to cold testing
Tooth sensibility with endo coldspray (-40°C) (positive or negative reaction of the patient)
Measured: 36 months
Number of patients without mobile teeth
Tooth mobility testing with two fingers according to the tooth mobility score (0-III)
Measured: 36 months
Number of patients with negative reaction to palpation testing
Palpation testing with a finger and little pressure (tenderness to palpation or no tenderness to palpation)
Measured: 36 months
Number of patients with negative reaction to percussion testing
Percussion testing of the treated tooth: backside of dental mirror (tenderness to percussion or no tenderness to percussion)
Measured: 36 months
Number of patients with periodontal probing depths within normal limits
Probing depths with a periodontal probe in mm
Measured: 36 months
Number of Patients without clinical signs of inflammation
Screening the oral mucosa for swelling, fistula and erythema
Measured: 36 months
Secondary outcomes (1)
Number of patients with a PAI score of I - II
Evaluation of the periapical status on periapical radiographs via periapical index (PAI)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial and Prospective Non-controlled Intervention Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Septodont, 3M
- Responsible party
- Principal investigator, Falk Schwendicke, Charite University, Berlin, Germany
- Investigators
- Falk Schwendicke, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807244
- Sponsor's protocol ID
- EA4/249/20
- Acronym
- Vitapulp
- Status last verified
- Mar 2021
- First submitted
- 11 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adl A, Javanmardi S, Abbaszadegan A. Assessment of tooth discoloration induced by biodentine and white mineral trioxide aggregate in the presence of blood. J Conserv Dent. 2019 Mar-Apr;22(2):164-168. doi: 10.4103/JCD.JCD_466_18.
PubMed 31142987Awawdeh L, Al-Qudah A, Hamouri H, Chakra RJ. Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. J Endod. 2018 Nov;44(11):1603-1609. doi: 10.1016/j.joen.2018.08.004. Epub 2018 Oct 3.
PubMed 30292451Duncan HF, Bjorndal L, van der Sluis L, Rechenberg DK, Simon S, Cooper PR, Ricucci D, Galler K. Third European Society of Endodontology (ESE) research meeting: ACTA, Amsterdam, The Netherlands, 26th October 2018: Deep caries and the exposed pulp: current and emerging therapeutic perspectives. Int Endod J. 2019 Feb;52(2):135-138. doi: 10.1111/iej.13059. No abstract available.
PubMed 30644590Burke FJT, Crisp RJ, Cowan AJ, Raybould L, Redfearn P, Sands P, Thompson O, Ravaghi V. A Randomised Controlled Trial of a Universal Bonding Agent at Three Years: Self Etch vs Total Etch. Eur J Prosthodont Restor Dent. 2017 Dec 1;25(4):220-227. doi: 10.1922/EJPRD_01692Burke08.
PubMed 29182212Camilieri J (2015) Mineral trioxide aggregate: present and future developments Endodontic Topics Volume 31, 31-46.
de Paris Matos T, Perdigao J, de Paula E, Coppla F, Hass V, Scheffer RF, Reis A, Loguercio AD. Five-year clinical evaluation of a universal adhesive: A randomized double-blind trial. Dent Mater. 2020 Nov;36(11):1474-1485. doi: 10.1016/j.dental.2020.08.007. Epub 2020 Sep 12.
PubMed 32933775Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20.
PubMed 29061359Haak R, Hahnel M, Schneider H, Rosolowski M, Park KJ, Ziebolz D, Hafer M. Clinical and OCT outcomes of a universal adhesive in a randomized clinical trial after 12 months. J Dent. 2019 Nov;90:103200. doi: 10.1016/j.jdent.2019.103200. Epub 2019 Sep 25.
PubMed 31562889Lawson NC, Robles A, Fu CC, Lin CP, Sawlani K, Burgess JO. Two-year clinical trial of a universal adhesive in total-etch and self-etch mode in non-carious cervical lesions. J Dent. 2015 Oct;43(10):1229-34. doi: 10.1016/j.jdent.2015.07.009. Epub 2015 Jul 29.
PubMed 26231300Linsuwanont P, Wimonsutthikul K, Pothimoke U, Santiwong B. Treatment Outcomes of Mineral Trioxide Aggregate Pulpotomy in Vital Permanent Teeth with Carious Pulp Exposure: The Retrospective Study. J Endod. 2017 Feb;43(2):225-230. doi: 10.1016/j.joen.2016.10.027. Epub 2016 Dec 29.
PubMed 28041685Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986 Feb;2(1):20-34. doi: 10.1111/j.1600-9657.1986.tb00119.x. No abstract available.
PubMed 3457698Taha NA, Abdelkhader SZ. Outcome of full pulpotomy using Biodentine in adult patients with symptoms indicative of irreversible pulpitis. Int Endod J. 2018 Aug;51(8):819-828. doi: 10.1111/iej.12903. Epub 2018 Feb 27.
PubMed 29397003Taha NA, Khazali MA. Partial Pulpotomy in Mature Permanent Teeth with Clinical Signs Indicative of Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2017 Sep;43(9):1417-1421. doi: 10.1016/j.joen.2017.03.033. Epub 2017 Jun 30.
PubMed 28673494Uesrichai N, Nirunsittirat A, Chuveera P, Srisuwan T, Sastraruji T, Chompu-Inwai P. Partial pulpotomy with two bioactive cements in permanent teeth of 6- to 18-year-old patients with signs and symptoms indicative of irreversible pulpitis: a noninferiority randomized controlled trial. Int Endod J. 2019 Jun;52(6):749-759. doi: 10.1111/iej.13071. Epub 2019 Jan 30.
PubMed 30638262Wolters WJ, Duncan HF, Tomson PL, Karim IE, McKenna G, Dorri M, Stangvaltaite L, van der Sluis LWM. Minimally invasive endodontics: a new diagnostic system for assessing pulpitis and subsequent treatment needs. Int Endod J. 2017 Sep;50(9):825-829. doi: 10.1111/iej.12793. No abstract available.
PubMed 28776717
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized-controlled and Non-controlled Intervention Trial: Treatment of Deep Carious Lesions in Permanent Molars
- ClinicalTrials.gov ID
- NCT04807244
- Acronym / sponsor ID
- Vitapulp / EA4/249/20
- Conditions
- Irreversible Pulpitis, Reversible Pulpitis, Dentine Caries
- Keywords
- Partial Pulpotomy, Full Pulpotomy, Selective Caries Removal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Septodont, 3M
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial and Prospective Non-controlled Intervention Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment of deep carious lesions: Randomized-controlled trail | Other | Procedure: Selective Caries Removal with Biodentine™, Procedure: Partial Pulpotomy with Biodentine™, Procedure: Direct composite filling after selective caries removal/full pulpotomy/partial pulpotomyTeeth 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. |
| Treatment of deep carious lesions: Prospective non-controlled intervention trial | Other | Procedure: Full Pulpotomy with Biodentine™, Procedure: Direct composite filling after selective caries removal/full pulpotomy/partial pulpotomyTeeth 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Treatment of deep carious lesions: Randomized-controlled trail |
| 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 or surgery | Treatment of deep carious lesions: Randomized-controlled trail |
| 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 or surgery | Treatment of deep carious lesions: Prospective non-controlled intervention trial |
| Direct composite filling after selective caries removal/full pulpotomy/partial pulpotomy1. Dentin cleaning with a low-speed round bur 2. Use of Scotchbond Universal™ and Filtek Supreme XTE™ according to manufacturer's recommendation | Procedure or surgery | Treatment of deep carious lesions: Prospective non-controlled intervention trial, Treatment of deep carious lesions: Randomized-controlled trail |
Primary outcome
Number of patients with positive reaction to cold testing
Time frame: 36 months
Tooth sensibility with endo coldspray (-40°C) (positive or negative reaction of the patient)
Number of patients without mobile teeth
Time frame: 36 months
Tooth mobility testing with two fingers according to the tooth mobility score (0-III)
Number of patients with negative reaction to palpation testing
Time frame: 36 months
Palpation testing with a finger and little pressure (tenderness to palpation or no tenderness to palpation)
Number of patients with negative reaction to percussion testing
Time frame: 36 months
Percussion testing of the treated tooth: backside of dental mirror (tenderness to percussion or no tenderness to percussion)
Number of patients with periodontal probing depths within normal limits
Time frame: 36 months
Probing depths with a periodontal probe in mm
Number of Patients without clinical signs of inflammation
Time frame: 36 months
Screening the oral mucosa for swelling, fistula and erythema
1 secondary outcome
Number of patients with a PAI score of I - II
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Background: PubMed 31142987Adl A, Javanmardi S, Abbaszadegan A. Assessment of tooth discoloration induced by biodentine and white mineral trioxide aggregate in the presence of blood. J Conserv Dent. 2019 Mar-Apr;22(2):164-168. doi: 10.4103/JCD.JCD_466_18.
- Background: PubMed 30292451Awawdeh L, Al-Qudah A, Hamouri H, Chakra RJ. Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. J Endod. 2018 Nov;44(11):1603-1609. doi: 10.1016/j.joen.2018.08.004. Epub 2018 Oct 3.
- Background: PubMed 30644590Duncan HF, Bjorndal L, van der Sluis L, Rechenberg DK, Simon S, Cooper PR, Ricucci D, Galler K. Third European Society of Endodontology (ESE) research meeting: ACTA, Amsterdam, The Netherlands, 26th October 2018: Deep caries and the exposed pulp: current and emerging therapeutic perspectives. Int Endod J. 2019 Feb;52(2):135-138. doi: 10.1111/iej.13059. No abstract available.
- Background: PubMed 29182212Burke FJT, Crisp RJ, Cowan AJ, Raybould L, Redfearn P, Sands P, Thompson O, Ravaghi V. A Randomised Controlled Trial of a Universal Bonding Agent at Three Years: Self Etch vs Total Etch. Eur J Prosthodont Restor Dent. 2017 Dec 1;25(4):220-227. doi: 10.1922/EJPRD_01692Burke08.
- BackgroundCamilieri J (2015) Mineral trioxide aggregate: present and future developments Endodontic Topics Volume 31, 31-46.
- Background: PubMed 32933775de Paris Matos T, Perdigao J, de Paula E, Coppla F, Hass V, Scheffer RF, Reis A, Loguercio AD. Five-year clinical evaluation of a universal adhesive: A randomized double-blind trial. Dent Mater. 2020 Nov;36(11):1474-1485. doi: 10.1016/j.dental.2020.08.007. Epub 2020 Sep 12.
- Background: PubMed 29061359Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20.
- Background: PubMed 31562889Haak R, Hahnel M, Schneider H, Rosolowski M, Park KJ, Ziebolz D, Hafer M. Clinical and OCT outcomes of a universal adhesive in a randomized clinical trial after 12 months. J Dent. 2019 Nov;90:103200. doi: 10.1016/j.jdent.2019.103200. Epub 2019 Sep 25.
- Background: PubMed 26231300Lawson NC, Robles A, Fu CC, Lin CP, Sawlani K, Burgess JO. Two-year clinical trial of a universal adhesive in total-etch and self-etch mode in non-carious cervical lesions. J Dent. 2015 Oct;43(10):1229-34. doi: 10.1016/j.jdent.2015.07.009. Epub 2015 Jul 29.
- Background: PubMed 28041685Linsuwanont P, Wimonsutthikul K, Pothimoke U, Santiwong B. Treatment Outcomes of Mineral Trioxide Aggregate Pulpotomy in Vital Permanent Teeth with Carious Pulp Exposure: The Retrospective Study. J Endod. 2017 Feb;43(2):225-230. doi: 10.1016/j.joen.2016.10.027. Epub 2016 Dec 29.
- Background: PubMed 3457698Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986 Feb;2(1):20-34. doi: 10.1111/j.1600-9657.1986.tb00119.x. No abstract available.
- Background: PubMed 29397003Taha NA, Abdelkhader SZ. Outcome of full pulpotomy using Biodentine in adult patients with symptoms indicative of irreversible pulpitis. Int Endod J. 2018 Aug;51(8):819-828. doi: 10.1111/iej.12903. Epub 2018 Feb 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Falk Schwendicke, Prof. study director
Charite University, Berlin, Germany
Questions about this trial
What is this clinical trial studying?
A study testing Selective Caries Removal with Biodentine™, Partial Pulpotomy with Biodentine™ and Full Pulpotomy with Biodentine™ in people with Irreversible Pulpitis and Reversible Pulpitis, run by Charite University, Berlin, Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sascha R Herbst, Dr. (450662697 ext. 004930, sascha.herbst@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with positive reaction to cold testing (time frame: 36 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04807244, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.