Outcomes of Partial Pulpotomy Treatment in Cariously Exposed Teeth

Treatment Outcomes of Partial Pulpotomy Using Two Different Calcium Silicate Materials in Cariously Exposed Mature Permanent Teeth: A Randomized Clinical Trial

The aim of this clinical trial is to learn how successful Biodentine and Theracal PT dental filling materials are in treating deep tooth decay in adults. It will also provide information about post-treatment pain. The main questions it aims to answer are:

Do Biodentine and Theracal PT dental filling materials treat exposed tooth decay in participants? Do they reduce the need for root canal treatment? After the application of Biodentine and Theracal PT 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 Theracal PT dental filling materials with each other.

Participants will undergo a single-session partial 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: Completed
• Conditions: Deep Dental Caries
• Intervention / Treatment: Device: Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France); Device: Theracal PT (resin modified calcium silicate-based cement) (Bisco Inc., Schaumburg, IL, USA)

• Study Type: Interventional
• Enrollment (Actual): 61
• 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 should be between 18-50 years

  • Should be able to give written informed consent
  • Should have systemic status (ASA 1)
  • Should have permanent molar or premolar (lower and upper) root development
  • Should be asymptomatic, deep (D3) or extremely deep (D4) caries
  • Should give vital response in cold test and electric pulp test
  • Should have teeth where the pulp is exposed with caries
  • Should not have pain during palpation and percussion
  • Should not have periodontal disease
  • Should have restorable teeth
  • Should have teeth without pulp necrosis, sinus tract or swelling/abscess
  • Should have bleeding time less than 10 minutes
  • Should be able to include a maximum of two teeth in a patient in the study (should be in different quadrants and there should be at least 2 weeks between treatment periods)

Exclusion Criteria:

• Teeth with incomplete root development

  • Severely affected teeth that do not respond to pulp sensitivity tests
  • Teeth with signs and symptoms of irreversible pulpitis
  • Teeth without signs of bleeding after communicating 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 at-risk 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: Partial 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: Partial Pulpotomy with Theracal PT	Device: Theracal PT (resin modified calcium silicate-based cement) (Bisco Inc., Schaumburg, IL, USA); It will be placed on the exposed pulp with the help of its injection tip 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

• 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.
• Ricucci D, Siqueira JF Jr, Li Y, Tay FR. Vital pulp therapy: histopathology and histobacteriology-based guidelines to treat teeth with deep caries and pulp exposure. J Dent. 2019 Jul;86:41-52. doi: 10.1016/j.jdent.2019.05.022. Epub 2019 May 21.
• 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): March 20, 2024
• Primary Completion (Actual): June 15, 2025
• Study Completion (Actual): June 20, 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: partial pulpotomy; deep dental caries; calcium silicate-based material
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium, Dietary; Calcium
• Other Study ID Numbers: FIRATUNI-DENTISTRY-TUBAGOK-002

Plan for Individual participant data (IPD)

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

IPD Plan Description

Title: Data Sharing for Parial Pulpotomy Treatment in Teeth with Cariously Exposed:

The objective of this IPD (Individual Participant Data) sharing plan is to enhance the understanding of the success of partial pulpotomy treatment in cariously exposed teeth using Biodentine and Theracal PT 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