Clinical Study of the Direct Pulp Capping in Primary Teeth

March 25, 2024 updated by: JINjin Yu, The Dental Hospital of Zhejiang University School of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The Affiliated Hospital of Stomatology, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: direct pulp capping
If a pulp exposure occurred, direct pulp capping will be performed according to the parents' wishes
Procedure: direct pulp capping
direct pulp capping
Active Comparator: pulpotomy
If a pulp exposure occurred, pulpotomy will be performed according to the parents' wishes
Procedure: pulpotomy
pulpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of the direct pulp capping
Time Frame: 12 months
The success rate of the direct pulp capping of primary teeth
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Dental Hospital of Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2022

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • DHZhejiangU-2022（22）

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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