Clinical Study of the Direct Pulp Capping in Primary Teeth

NCT05297344 | Completed

• 1 other identifier: DHZhejiangU-2022（22）
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Direct Pulp Capping; Pulpotomy; Primary Teeth

Outcome Measures

Primary Outcomes (1)

• Success rate of the direct pulp capping

  The success rate of the direct pulp capping of primary teeth

  12 months

Study Arms (2)

direct pulp capping

EXPERIMENTAL

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

Procedure: direct pulp capping

pulpotomy

ACTIVE COMPARATOR

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

Procedure: pulpotomy

Interventions

direct pulp capping PROCEDURE

direct pulp capping

direct pulp capping

pulpotomy PROCEDURE

pulpotomy

pulpotomy

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Dental Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Affiliated Hospital of Stomatology, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

Pulpotomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physicians

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 28, 2022
• Study Start: February 18, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)