- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jinjin Yu
- Phone Number: 13588003034
- Email: m05yujinjin@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- The Affiliated Hospital of Stomatology, Zhejiang University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
|
direct pulp capping
|
Active Comparator: pulpotomy
If a pulp exposure occurred, pulpotomy will be performed according to the parents' wishes
|
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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