Outcomes of Partial Pulpotomy Treatment in Cariously Exposed Teeth

Firat University

Status and phase: Completed; Phase 4

Conditions: Deep Dental Caries

Treatments: 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

Funder types: Other

Identifiers

NCT06802549

FIRATUNI-DENTISTRY-TUBAGOK-002

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 2 patient groups

Partial Pulpotomy with Biodentine

Active Comparator group

Treatment:

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

Partial Pulpotomy with Theracal PT

Experimental group

Treatment:

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