Outcomes of Full Pulpotomy Treatment in Teeth With Symptoms of Irreversible Pulpitis
NCT ID: NCT06802536
Last Updated: 2025-09-23
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2024-04-15
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Total Pulpotomy with Biodentine
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.
Total Pulpotomy with NeoPutty
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
Exclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
No
Sponsors
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Firat University
OTHER
Responsible Party
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Tuba Gök
PhD., Assistant Professor
Locations
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Firat University
Elâzığ, , Turkey (Türkiye)
Countries
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References
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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.
Duncan 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.
Nagendrababu 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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FIRATUNI-DENTISTRY-TUBAGOK-001
Identifier Type: -
Identifier Source: org_study_id
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