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CompletedNCT05297344Updated Mar 27, 2024

Clinical Study of the Direct Pulp Capping in Primary Teeth

An interventional study of direct pulp capping and pulpotomy in Direct Pulp Capping, Pulpotomy and Primary Teeth, sponsored by The Dental Hospital of Zhejiang University School of Medicine. Completed at 1 site in China. Open to participants aged 4 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-27.

Sponsored by The Dental Hospital of Zhejiang University School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
4 Years to 8 Years
Sex
All
01

Study summary

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.
02

Conditions studied

  • Direct Pulp Capping
  • Pulpotomy
  • Primary Teeth
03

In context

Lead sponsor

The Dental Hospital of Zhejiang University School of Medicine is the lead sponsor of 25 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    direct pulp capping

    If a pulp exposure occurred, direct pulp capping will be performed according to the parents' wishes

    Procedure: direct pulp capping

  • Active comparator
    pulpotomy

    If a pulp exposure occurred, pulpotomy will be performed according to the parents' wishes

    Procedure: pulpotomy

Interventions

  • Proceduredirect pulp capping

    direct pulp capping

  • Procedurepulpotomy

    pulpotomy

06

What researchers measure

Primary outcomes

  1. Success rate of the direct pulp capping

    The success rate of the direct pulp capping of primary teeth

    Time frame: 12 months

07

Study locations

1 site
  • The Affiliated Hospital of Stomatology, Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05297344
Lead sponsor
The Dental Hospital of Zhejiang University School of Medicine
Responsible party
JINjin Yu (Attending Physicians, The Dental Hospital of Zhejiang University School of Medicine) — Principal investigator
First posted
Mar 28, 2022
Start date
Feb 18, 2022
Primary completion
Oct 31, 2023
Completion
Oct 31, 2023
Last update
Mar 27, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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