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Completed

NCT Number: NCT05297344

Clinical Study of the Direct Pulp Capping in Primary Teeth

Research content: select the patients with accidental pulp exposure or decayed pulp exposure in the pediatric dentistry department of The Affiliated Stomatology Hospital of Zhejiang University School of Medicine from February 2022 to October 2022.

1. Strictly implement the case selection criteria to reduce the deviation. 2. Conduct uniform training and assessment for doctors. 3. Record in detail: the age, gender, tooth position, cavity type, x-Ray examination, size and reason of pulp exposure, time of hemostasis, filling material, signs and symptoms of initial consultation and follow-up, etc. 4. Analyze the clinical data to study the success rate of direct pulp capping of primary teeth; analyze the influence of various factors to study how to improve the success rate of direct pulp capping of primary teeth.

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Key information

Conditions

Direct Pulp Capping Primary Teeth Pulpotomy

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Hospital of Stomatology, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • No irreversible signs or symptoms of pulpitis in the affected tooth.
  • Mechanical pulp exposure caused by cavity preparation or trauma, or pulp exposure after decayed tissue removal, with healthy dentin around the pulp exposure.
  • The size of the exposed pulp<1 mm.
  • The morphology of pulp tissue at the pulp exposure is normal, and the bleeding should be able to be controlled within 5 minutes.
  • X-ray showed that there was no abnormal resorption or fracture of the root and no lesions around the root.

Exclusion criteria

  • The child is unable to cooperate with the treatment.
  • Pulp exposure > 1 mm.
  • Irreversible signs or symptoms of pulpitis in the affected tooth.
  • Abnormal morphology of the pulp tissue at the pulp exposure, much bleeding and inability to stop bleeding.
  • X-ray shows: abnormal resorption or fracture of the tooth root and lesions around the root.
  • The parents or the child refused to participate in the experiment.

Treatment and study plan

direct pulp capping

Procedure

direct pulp capping

Pulpotomy

Procedure

pulpotomy

Primary outcomes

  1. Success rate of the direct pulp capping

    Time frame: 12 months

    The success rate of the direct pulp capping of primary teeth

Sponsors and collaborators

Lead sponsor

The Dental Hospital of Zhejiang University School of Medicine

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 28, 2022
Registry last updated
Mar 27, 2024

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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