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

NCT06802536 | Active Not Recruiting Phase 4 DMC FDA Device

• 1 other identifier: FIRATUNI-DENTISTRY-TUBAGOK-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Pulpitis - Irreversible

Keywords

irreversible pulpitis; calcium silicate-based cement; total pulpotomy

Outcome Measures

Primary Outcomes (1)

• "Tooth survival". Both clinical and radiographic healing means "Tooth survival". Clinical healing; absence of clinical symptoms. Radiographic healing; absence of emerging periapical radiolucency.

  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.

  From enrollment to the follow up at 1 week, 3,6.12 months"

Study Arms (2)

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)

Interventions

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.

Total Pulpotomy with Biodentine

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.

Total Pulpotomy with NeoPutty

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Firat University

Elâzığ, 23119, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 30664240 RESULT

• 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.

  PMID: 35080024 RESULT

• 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.

  PMID: 32266988 RESULT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD., Assistant Professor

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 31, 2025
• Study Start: April 15, 2024
• Primary Completion: December 26, 2025
• Study Completion: December 31, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)