CompletedNCT06802536Updated Sep 4, 2026

Outcomes of Full Pulpotomy Treatment in Teeth With Symptoms of Irreversible Pulpitis

A Phase 4 interventional study of Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France) and NeoPutty (calcium silicate-based cement) (Avalon Biomed, Bradenton, USA) in Pulpitis - Irreversible, sponsored by Firat University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Firat University · Phase 4, Interventional, and Treatment

From the registry’s dates

Registered 9 months after the study started (first participant enrolled Apr 2024, registered Jan 2025).

Phase: Phase 4
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study 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. 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.

Conditions studied

Pulpitis - Irreversible

Keywords

irreversible pulpitis
calcium silicate-based cement
total pulpotomy

In context

Lead sponsor

Firat University is the lead sponsor of 112 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

- 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
  - 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

Exclusion Criteria:

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
- 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.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 60 participants (actual)

Study arms

Active comparator
Total Pulpotomy with Biodentine
Device: Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France)
Experimental
Total Pulpotomy with NeoPutty
Device: NeoPutty (calcium silicate-based cement) (Avalon Biomed, Bradenton, USA)

Interventions

DeviceBiodentine (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.
DeviceNeoPutty (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.

What researchers measure

Primary outcomes

"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"

Secondary outcomes

"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"

Study locations

1 site

Firat University
Elâzığ, Elâzığ 23119, Turkey (Türkiye)

References and documents

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 30664240 ↗
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. PubMed 35080024 ↗
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. PubMed 32266988 ↗

Study documents

Study protocol · Dec 5, 2023
Informed consent form · Dec 5, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06802536
Lead sponsor: Firat University
Responsible party: Tuba Gök (PhD., Assistant Professor, Firat University) — Principal investigator
First posted: Jan 31, 2025
Start date: Apr 15, 2024
Primary completion: Dec 26, 2025
Completion: Dec 31, 2025
Last update: Sep 4, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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