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Completed

NCT Number: NCT06802549

Outcomes of Partial Pulpotomy Treatment in Cariously Exposed Teeth

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.

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Key information

Conditions

Deep Dental Caries

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 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.

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

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

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 Partial Pulpotomy Using Two Different Calcium Silicate Materials in Cariously Exposed Mature Permanent Teeth: 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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