Direct Pulp CappingNCT05297344
Clinical Study of the Direct Pulp Capping in Primary Teeth
A study testing direct pulp capping and pulpotomy in people with Direct Pulp Capping and Pulpotomy, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Direct Pulp Capping, Pulpotomy, Primary Teeth
- What is being tested?
- direct pulp capping and pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Stomatology, Zhejiang University School of Medicine
Hangzhou, Zhejiang
About this study
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.
- 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
- Being tested
- direct pulp capping, pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct pulp cappingProcedure or surgery
direct pulp capping
pulpotomyProcedure or surgery
pulpotomy
| Study group | Role | What they receive |
|---|---|---|
| direct pulp capping | Experimental | If a pulp exposure occurred, direct pulp capping will be performed according to the parents' wishes Receives: Procedure: direct pulp capping |
| pulpotomy | Active comparator | If a pulp exposure occurred, pulpotomy will be performed according to the parents' wishes Receives: Procedure: pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of the direct pulp capping
The success rate of the direct pulp capping of primary teeth
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start18 Feb 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Direct Pulp CappingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JINjin Yu, The Dental Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297344
- Sponsor's protocol ID
- DHZhejiangU-2022（22）
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2022
- Last updated
- 27 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Direct Pulp Capping in Primary Teeth
- ClinicalTrials.gov ID
- NCT05297344
- Acronym / sponsor ID
- DHZhejiangU-2022（22）
- Conditions
- Direct Pulp Capping, Pulpotomy, Primary Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| direct pulp capping | Experimental | Procedure: direct pulp cappingIf a pulp exposure occurred, direct pulp capping will be performed according to the parents' wishes |
| pulpotomy | Active comparator | Procedure: pulpotomyIf a pulp exposure occurred, pulpotomy will be performed according to the parents' wishes |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| direct pulp cappingdirect pulp capping | Procedure or surgery | direct pulp capping |
| pulpotomypulpotomy | Procedure or surgery | pulpotomy |
Primary outcome
Success rate of the direct pulp capping
Time frame: 12 months
The success rate of the direct pulp capping of primary teeth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: No
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Influence of Proximal Caries on Outcome of Direct Pulp Capping in Permanent Mandibular Molars With Reversible Pulpitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing direct pulp capping and pulpotomy in people with Direct Pulp Capping and Pulpotomy, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of the direct pulp capping (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.