Pulpitis - IrreversibleNCT06514053
Prognostic Biomarkers for Pulpotomy Outcome
A study testing Full pulpotomy and Root canal treatment in people with Pulpitis - Irreversible, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study will recruit 180 molars diagnosed with irreversible pulpitis. Full pulpotomy will be performed on 120 teeth, while RCT (root canal treatment) will be conducted on another cohort of 60 teeth as the control for assessing long-term outcomes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Full pulpotomy and Root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Permanent molars showing clinical and radiographic evidence of a deep carious lesion (extend to the three-quarters thickness of dentine radiographically) extending close to the pulp chamber
- Clinical diagnosis of irreversible pulpitis, including spontaneous pain, lingering pain with cold stimulation, no or mild tenderness to percussion, normal apical tissue or widening of the periodontal ligament space but with no signs of periapical periodontitis (i.e., PAI score 1 or 2)
- Positive response to cold and electric pulp test.
Who cannot join
- Tooth with no response to the cold and electric tests, presence of apical radiolucency (greater than periodontal widening), signs of canal calcification and resorption, history of trauma, unrestorable or nonfunctional teeth, and evidence of perio-endo lesion
- Intraoperative bleeding time is more than 10 minutes or less than 10 μL pulpal blood can be obtained
- Patients with a compromised immune status (such as HIV or organ transplant) or with any history of taking analgesics/antibiotics in the past one week.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Clinical Research Centre, Faculty of Dentistry, The University of Hong Kong
Hong Kong
Rong Cen, +852 28590290
About this study
Official title: Discovering Prognostic Biomarkers for Pulpotomy Outcome in Permanent Mature Teeth With Irreversible Pulpitis
This study will recruit 180 molars diagnosed with irreversible pulpitis. Full pulpotomy will be performed on 120 teeth, while RCT (root canal treatment) will be conducted on another cohort of 60 teeth as the control for assessing long-term outcomes. Additionally, 12 blood samples and pulp tissues from healthy teeth receiving elective RCT will be collected as the controls. The first pulpal blood sample will be collected after caries removal and pulp exposure. Subsequently, the entire coronal pulp tissue will be removed and collected for histological examination, image-based spatial and scRNA-seq analyses. A second pulpal blood sample will be collected from the radicular pulp tissue. Both blood samples will be used to profile the inflammation-related biomarkers through multiplex immunoassays. The remaining pulp tissue will be covered by Biodentine and restored with resin-based composite. Pulpotomy treatment outcomes will be evaluated clinically and radiographically at 6 and 12 months. The biomarkers identified in the pulpal blood and histology and the single-cell transcriptomes of the coronal pulp will be compared with the treatment "success" and "failure" groups upon one year. The outcome of RCT will be compared with that of full pulpotomy at 24 months.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Full pulpotomy, Root canal treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full pulpotomyProcedure or surgery
A full pulpotomy will be performed by removing the entire roof of the pulp chamber and the remaining pulp tissue will be covered by Biodentine.
Root canal treatmentProcedure or surgery
The regular procedure of root canal treatment will be performed on teeth with irreversible pulpitis
| Study group | Role | What they receive |
|---|---|---|
| Full pulpotomy | Active comparator | Not described Receives: Procedure: Full pulpotomy |
| Root canal treatment | Active comparator | Not described Receives: Procedure: Root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Success rate of full pulpotomy and RCT in teeth with irreversible pulpitis
Measured: 2 years
Biomarkers
Quantitative descriptive analysis of the expression of biomarkers commonly found in tissue inflammation using multiplex immunoassay (Millipore, USA). The kits include targets as follows: sCD40L;EGF;Eotaxin;FGF-2;Flt-3 ligand;Fractalkine;G-CSF;GM-CSF;GROα;IFNα2;IFNγ;IL-1α;IL-1β;IL-1ra;IL-2;IL-3;IL-4;IL-5;IL-6;IL-7;IL-8;IL-9;IL-10;IL-12 (p40);IL-12 (p70);IL-13;IL-15;IL-17A;IL-17E/IL-25;IL-17F;IL-18;IL-22;IL-27;IP-10;MCP-1;MCP-3;M-CSF;MDC (CCL22);MIG;MIP-1α;MIP-1β;PDGF-AA;PDGF-AB/BB;RANTES;TGFα;TNFα;TNFβ;VEGF-A; MMP-1, -2, -7, -9, -10.
Measured: 2 years
Secondary outcomes (1)
Correlation
Correlation of biomarkers' expression to the outcome of full pulpotomy in teeth with irreversible pulpitis to identify objective prognostic biomarkers for full pulpotomy; biomarkers to investigate are described in Outcome 2
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Jan 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Zhang Chengfei, The University of Hong Kong
- Investigators
- Chengfei Zhang, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514053
- Sponsor's protocol ID
- UW 23-133
- Status last verified
- Jul 2024
- First submitted
- 17 Apr 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovering Prognostic Biomarkers for Pulpotomy Outcome in Permanent Mature Teeth With Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT06514053
- Acronym / sponsor ID
- UW 23-133
- Conditions
- Pulpitis - Irreversible
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Jul 2024 (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.
This study will recruit 180 molars diagnosed with irreversible pulpitis. Full pulpotomy will be performed on 120 teeth, while RCT (root canal treatment) will be conducted on another cohort of 60 teeth as the control for assessing long-term outcomes. Additionally, 12 blood samples and pulp tissues from healthy teeth receiving elective RCT will be collected as the controls. The first pulpal blood sample will be collected after caries removal and pulp exposure. Subsequently, the entire coronal pulp tissue will be removed and collected for histological examination, image-based spatial and scRNA-seq analyses. A second pulpal blood sample will be collected from the radicular pulp tissue. Both blood samples will be used to profile the inflammation-related biomarkers through multiplex immunoassays. The remaining pulp tissue will be covered by Biodentine and restored with resin-based composite. Pulpotomy treatment outcomes will be evaluated clinically and radiographically at 6 and 12 months. The biomarkers identified in the pulpal blood and histology and the single-cell transcriptomes of the coronal pulp will be compared with the treatment "success" and "failure" groups upon one year. The outcome of RCT will be compared with that of full pulpotomy at 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full pulpotomy | Active comparator | Procedure: Full pulpotomy |
| Root canal treatment | Active comparator | Procedure: Root canal treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Permanent molars showing clinical and radiographic evidence of a deep carious lesion (extend to the three-quarters thickness of dentine radiographically) extending close to the pulp chamber
- Clinical diagnosis of irreversible pulpitis, including spontaneous pain, lingering pain with cold stimulation, no or mild tenderness to percussion, normal apical tissue or widening of the periodontal ligament space but with no signs of periapical periodontitis (i.e., PAI score 1 or 2)
- Positive response to cold and electric pulp test.
Key exclusion criteria (3 listed)
- Tooth with no response to the cold and electric tests, presence of apical radiolucency (greater than periodontal widening), signs of canal calcification and resorption, history of trauma, unrestorable or nonfunctional teeth, and evidence of perio-endo lesion
- Intraoperative bleeding time is more than 10 minutes or less than 10 μL pulpal blood can be obtained
- Patients with a compromised immune status (such as HIV or organ transplant) or with any history of taking analgesics/antibiotics in the past one week.
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 |
|---|---|---|
| Full pulpotomyA full pulpotomy will be performed by removing the entire roof of the pulp chamber and the remaining pulp tissue will be covered by Biodentine. | Procedure or surgery | Full pulpotomy |
| Root canal treatmentThe regular procedure of root canal treatment will be performed on teeth with irreversible pulpitis | Procedure or surgery | Root canal treatment |
Primary outcome
Success rate
Time frame: 2 years
Success rate of full pulpotomy and RCT in teeth with irreversible pulpitis
Biomarkers
Time frame: 2 years
Quantitative descriptive analysis of the expression of biomarkers commonly found in tissue inflammation using multiplex immunoassay (Millipore, USA). The kits include targets as follows: sCD40L;EGF;Eotaxin;FGF-2;Flt-3 ligand;Fractalkine;G-CSF;GM-CSF;GROα;IFNα2;IFNγ;IL-1α;IL-1β;IL-1ra;IL-2;IL-3;IL-4;IL-5;IL-6;IL-7;IL-8;IL-9;IL-10;IL-12 (p40);IL-12 (p70);IL-13;IL-15;IL-17A;IL-17E/IL-25;IL-17F;IL-18;IL-22;IL-27;IP-10;MCP-1;MCP-3;M-CSF;MDC (CCL22);MIG;MIP-1α;MIP-1β;PDGF-AA;PDGF-AB/BB;RANTES;TGFα;TNFα;TNFβ;VEGF-A; MMP-1, -2, -7, -9, -10.
1 secondary outcome
Correlation
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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Pain
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.
Chengfei Zhang principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full pulpotomy and Root canal treatment in people with Pulpitis - Irreversible, run by The University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 Jul 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rong Cen (+852 28590290, cenrong@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 2 years). The study lists 2 primary outcomes in all. 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 23 Jul 2024.