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

Firat University

Status and phase: Active, not recruiting; Phase 4

Conditions: Pulpitis - Irreversible

Treatments: Device: NeoPutty (calcium silicate-based cement) (Avalon Biomed, Bradenton, USA); Device: Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France)

Study type: Interventional

Funder types: Other

Identifiers

NCT06802536

FIRATUNI-DENTISTRY-TUBAGOK-001

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Total Pulpotomy with Biodentine

Active Comparator group

Treatment:

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

Total Pulpotomy with NeoPutty

Experimental group

Treatment:

Device: NeoPutty (calcium silicate-based cement) (Avalon Biomed, Bradenton, USA)