Outcomes of Partial Pulpotomy Treatment in Cariously Exposed Teeth

NCT ID: NCT06802549

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2025-06-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Partial Pulpotomy with Biodentine

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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 Theracal PT

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Firat University

OTHER

Sponsor Role: lead

Responsible Party

Tuba Gök

PhD., Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Firat University

Elâzığ, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 35080024 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31121241 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30664240 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

FIRATUNI-DENTISTRY-TUBAGOK-002

Identifier Type: -

Identifier Source: org_study_id