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NCT Number: NCT06802536

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pulpitis - Irreversible

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Firat University

Elâzığ, 23119, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Device

It will be placed on the exposed pulp with the help of a carrier and the exposed pulp will be covered with material.

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.

    Time frame: 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.

    Time frame: From enrollment to the follow up at 1 week, 3,6.12 months"

Sponsors and collaborators

Lead sponsor

Firat University

Other

Registry information

Official study title

Treatment Outcomes of Full Pulpotomy Using Two Different Calcium Silicate-based Materials in Mature Permanent Teeth With Irreversible Pulpitis Symptoms: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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