Outcomes of Partial Pulpotomy Treatment in Cariously Exposed Teeth

NCT06802549 | Completed Phase 4 DMC FDA Device

• 1 other identifier: FIRATUNI-DENTISTRY-TUBAGOK-002
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deep Dental Caries

Keywords

deep dental caries; partial pulpotomy; calcium silicate-based material

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)

Partial Pulpotomy with Biodentine

ACTIVE COMPARATOR

Device: Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France)

Partial Pulpotomy with Theracal PT

EXPERIMENTAL

Device: Theracal PT (resin modified calcium silicate-based cement) (Bisco Inc., Schaumburg, IL, 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

Partial Pulpotomy with Biodentine

Theracal PT (resin modified calcium silicate-based cement) (Bisco Inc., Schaumburg, IL, USA) DEVICE

It will be placed on the exposed pulp with the help of its injection tip and the exposed pulp will be covered with material

Partial Pulpotomy with Theracal PT

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Firat University

Elâzığ, 23119, Turkey (Türkiye)

Location

Related Publications (3)

• 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

• 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.

  PMID: 31121241 RESULT

• 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

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: March 20, 2024
• Primary Completion: June 15, 2025
• Study Completion: June 20, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

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

Locations

TU (1)