Clinical Study of the Direct Pulp Capping in Primary Teeth

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05297344

Enrollment

Registered

2022-03-28

Start date

2022-02-18

Completion date

2023-10-31

Last updated

2024-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Direct Pulp Capping, Pulpotomy, Primary Teeth

Brief 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.

Interventions

PROCEDUREdirect pulp capping

direct pulp capping

PROCEDUREpulpotomy

pulpotomy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 8 Years

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

* 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.

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026