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

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?

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 Overview

• Status: Active, not recruiting
• Conditions: Pulpitis - Irreversible
• Intervention / Treatment: Device: Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France); Device: NeoPutty (calcium silicate-based cement) (Avalon Biomed, Bradenton, USA)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Elâzığ, Turkey (Türkiye), 23119
    • Firat University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Total Pulpotomy with Biodentine	Device: 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.
Experimental: Total Pulpotomy with NeoPutty	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
"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 Outcome Measures

Outcome Measure	Time Frame
"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"

Collaborators and Investigators

• Sponsor: Firat University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Estimated): December 26, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 25, 2025
• First Posted (Actual): January 31, 2025

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 20, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: irreversible pulpitis; total pulpotomy; calcium silicate-based cement
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Dental Pulp Diseases; Tooth Diseases; Pulpitis; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium, Dietary; Calcium
• Other Study ID Numbers: FIRATUNI-DENTISTRY-TUBAGOK-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes