Pulpitis - IrreversiblePhase 4NCT06802536
Outcomes of Full Pulpotomy Treatment in Teeth With Symptoms of Irreversible Pulpitis
A Phase 4 study testing Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France) and NeoPutty (calcium silicate-based cement) (Avalon Biomed, Bradenton, USA) in people with Pulpitis - Irreversible, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical trial is to learn how successful Biodentine and NeoPutty dental filling materials are in treating dental pulp inflammation in adults. It will also provide information about post-treatment pain. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France) and NeoPutty (calcium silicate-based cement) (Avalon Biomed, Bradenton, USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2024to 31 Dec 2025
- Phase
- Phase 4
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Patient age must be between 18-50 years
- Must be able to give written informed consent
- Must have systemic status (ASA 1)
- Must have mature permanent molar or premolar (lower upper)
- Must be symptomatic (spontaneous pain - mild to severe), extremely deep (D4) carious teeth
- Must have pulp exposure in non-selective carious cleaning procedure
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- Must have vital response in cold test and electric pulp test
- Must have no periodontal disease
- Must have restorable teeth
- Must have teeth without pulp necrosis, sinus tract or swelling/abscess
- Must have bleeding time less than 10 minutes
- Maximum two teeth in a patient must be included in the study (must be in different quadrants and must have at least 2 weeks between treatment periods)
Who cannot join
- Teeth with incomplete root development
- Teeth without symptoms of irreversible pulpitis
- Severely affected teeth that do not respond to pulp sensitivity tests
- Teeth without signs of bleeding after exposure with the pulp chamber
- Teeth with pulp chamber open to the oral environment
- Teeth with periodontal pockets greater than 4 mm deep
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- Teeth with suspected cracks or crown fractures that may be responsible for pulp pathology
- Teeth with uncontrolled bleeding
- Medically risky patients will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Outcomes of Full Pulpotomy Using Two Different Calcium Silicate-based Materials in Mature Permanent Teeth With Irreversible Pulpitis Symptoms: A Randomized Clinical Trial
The aim of this clinical trial is to learn how successful Biodentine and NeoPutty dental filling materials are in treating dental pulp inflammation in adults. It will also provide information about post-treatment pain. The main questions it aims to answer are:
Do Biodentine and NeoPutty dental filling materials treat dental pulpitis in participants? Do they reduce the need for root canal treatment?
Read more
After the application of Biodentine and NeoPutty dental filling materials to the participants, the pain and symptoms that cause pain may not decrease. In this case, the tooth may be treated with root canal treatment.
The researchers will compare the clinical success of Biodentine and NeoPutty dental filling materials with each other.
Participants will undergo a single-session pulpotomy treatment with the dental filling materials mentioned above. Clinical and radiographic follow-ups will then be performed at 3, 6 and 12 months, and records will be kept.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France), NeoPutty (calcium silicate-based cement) (Avalon Biomed, Bradenton, USA)
- Keywords
- irreversible pulpitis, calcium silicate-based cement, total pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France)Device
It will be placed on the exposed pulp with the help of a carrier and the exposed pulp will be covered with material.
NeoPutty (calcium silicate-based cement) (Avalon Biomed, Bradenton, USA)Device
It will be placed on the exposed pulp with the help of a carrier and the exposed pulp will be covered with material.
| Study group | Role | What they receive |
|---|---|---|
| Total Pulpotomy with Biodentine | Active comparator | Not described Receives: Device: Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France) |
| Total Pulpotomy with NeoPutty | Experimental | Not described Receives: Device: NeoPutty (calcium silicate-based cement) (Avalon Biomed, Bradenton, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Tooth survival". Both clinical and radiographic healing means "Tooth survival". Clinical healing; absence of clinical symptoms. Radiographic healing; absence of emerging periapical radiolucency.
Measured: From enrollment to the end of treatment at 1 year"
Secondary outcomes (1)
"Post operative pain". It will be evaluated with a 10-unit visual analog scale. 0: no pain, 1-3 mild pain, 4-6 moderate-severe pain, 7-9 very severe pain, 10 worst pain.
Measured: From enrollment to the follow up at 1 week, 3,6.12 months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start15 Apr 2024
- Primary completion26 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Gök, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802536
- Sponsor's protocol ID
- FIRATUNI-DENTISTRY-TUBAGOK-001
- Status last verified
- Sep 2026
- First submitted
- 20 Jan 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Title: Data Sharing for Total Pulpotomy Treatment in Teeth Diagnosed with Irreversible Pulpitis Using Biodentine and NeoPutty Materials Objective: The objective of this IPD (Individual Participant Data) sharing plan is to enhance the understanding of the success of total pulpotomy treatment in teeth diagnosed with irreversible pulpitis using Biodentine and NeoPutty materials, by encouraging and supporting data analysis. Data Access Conditions: Access to the data is available to researchers who present a valid proposal for research purposes and sign a data use agreement. All applications will be reviewed by the study management committee. Data Use: Data may only be used for scientific and ethical research purposes. Data Storage: Data will be stored for a period of ten years following the completion of the study and will be securely disposed of at the end of this period. Data Protection: Data will be stored under strict security protocols and accessible only to authorized personnel.
Publications
European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080.
PubMed 30664240Duncan HF. Present status and future directions-Vital pulp treatment and pulp preservation strategies. Int Endod J. 2022 May;55 Suppl 3(Suppl 3):497-511. doi: 10.1111/iej.13688. Epub 2022 Feb 3.
PubMed 35080024Nagendrababu V, Duncan HF, Bjorndal L, Kvist T, Priya E, Jayaraman J, Pulikkotil SJ, Dummer PMH. PRIRATE 2020 guidelines for reporting randomized trials in Endodontics: explanation and elaboration. Int Endod J. 2020 Jun;53(6):774-803. doi: 10.1111/iej.13304. Epub 2020 May 9.
PubMed 32266988
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcomes of Full Pulpotomy Using Two Different Calcium Silicate-based Materials in Mature Permanent Teeth With Irreversible Pulpitis Symptoms: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06802536
- Acronym / sponsor ID
- FIRATUNI-DENTISTRY-TUBAGOK-001
- Conditions
- Pulpitis - Irreversible
- Keywords
- irreversible pulpitis, calcium silicate-based cement, total pulpotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 26 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 31 Jan 2025 (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 aim of this clinical trial is to learn how successful Biodentine and NeoPutty dental filling materials are in treating dental pulp inflammation in adults. It will also provide information about post-treatment pain. The main questions it aims to answer are:
Do Biodentine and NeoPutty dental filling materials treat dental pulpitis in participants? Do they reduce the need for root canal treatment?
After the application of Biodentine and NeoPutty dental filling materials to the participants, the pain and symptoms that cause pain may not decrease. In this case, the tooth may be treated with root canal treatment.
The researchers will compare the clinical success of Biodentine and NeoPutty dental filling materials with each other.
Participants will undergo a single-session pulpotomy treatment with the dental filling materials mentioned above. Clinical and radiographic follow-ups will then be performed at 3, 6 and 12 months, and records will be kept.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Pulpotomy with Biodentine | Active comparator | Device: Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France) |
| Total Pulpotomy with NeoPutty | Experimental | Device: NeoPutty (calcium silicate-based cement) (Avalon Biomed, Bradenton, USA) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- • Patient age must be between 18-50 years
Key exclusion criteria (9 listed)
- Teeth with incomplete root development
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 |
|---|---|---|
| Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France)It will be placed on the exposed pulp with the help of a carrier and the exposed pulp will be covered with material. | Device | Total Pulpotomy with Biodentine |
| NeoPutty (calcium silicate-based cement) (Avalon Biomed, Bradenton, USA)It will be placed on the exposed pulp with the help of a carrier and the exposed pulp will be covered with material. | Device | Total Pulpotomy with NeoPutty |
Primary outcome
"Tooth survival". Both clinical and radiographic healing means "Tooth survival". Clinical healing; absence of clinical symptoms. Radiographic healing; absence of emerging periapical radiolucency.
Time frame: From enrollment to the end of treatment at 1 year"
1 secondary outcome
"Post operative pain". It will be evaluated with a 10-unit visual analog scale. 0: no pain, 1-3 mild pain, 4-6 moderate-severe pain, 7-9 very severe pain, 10 worst pain.
Time frame: From enrollment to the follow up at 1 week, 3,6.12 months"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Results publication: PubMed 30664240European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080.
- Results publication: PubMed 35080024Duncan HF. Present status and future directions-Vital pulp treatment and pulp preservation strategies. Int Endod J. 2022 May;55 Suppl 3(Suppl 3):497-511. doi: 10.1111/iej.13688. Epub 2022 Feb 3.
- Results publication: PubMed 32266988Nagendrababu V, Duncan HF, Bjorndal L, Kvist T, Priya E, Jayaraman J, Pulikkotil SJ, Dummer PMH. PRIRATE 2020 guidelines for reporting randomized trials in Endodontics: explanation and elaboration. Int Endod J. 2020 Jun;53(6):774-803. doi: 10.1111/iej.13304. Epub 2020 May 9.
- Individual participant dataSharing planned: Yes. Title: Data Sharing for Total Pulpotomy Treatment in Teeth Diagnosed with Irreversible Pulpitis Using Biodentine and NeoPutty Materials Objective: The objective of this IPD (Individual Participant Data) sharing plan is to enhance the understanding of the success of total pulpotomy treatment in teeth diagnosed with irreversible pulpitis using Biodentine and NeoPutty materials, by encouraging and supporting data analysis. Data Access Conditions: Access to the data is available to researchers who present a valid proposal for research purposes and sign a data use agreement. All applications will be reviewed by the study management committee. Data Use: Data may only be used for scientific and ethical research purposes. Data Storage: Data will be stored for a period of ten years following the completion of the study and will be securely disposed of at the end of this period. Data Protection: Data will be stored under strict security protocols and accessible only to authorized personnel.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France) and NeoPutty (calcium silicate-based cement) (Avalon Biomed, Bradenton, USA) in people with Pulpitis - Irreversible, run by Firat University at 1 site in Turkey (Türkiye).
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 12 inclusion and 9 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: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Tooth survival". Both clinical and radiographic healing means "Tooth survival". Clinical healing; absence of clinical symptoms. Radiographic healing; absence of emerging periapical radiolucency. (time frame: From enrollment to the end of treatment at 1 year"). 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 NCT06802536, which also lists 3 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 4 Sep 2026.