Irreversible PulpitisNCT05622266
Effectiveness of Pulpotomy in the Management of Mature Permanent Tooth With Irreversible Pulpits
A study testing Pulpotomy and Root Canal Therapy in people with Irreversible Pulpitis and Mature Teeth, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This study is to evaluate the effectiveness of pulpotomy in mature permanent tooth with irreversible pulpits, and compare the clinical efficacy of pulpotomy and root canal therapy. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis, Mature Teeth
- What is being tested?
- Pulpotomy and Root Canal Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Dec 2024
- 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Intended to participate with this study, and provide informed assent/consent. Aged 18 and 59 years. At least one mature permanent teeth diagnosed as acute pulpitis or chronic pulpitis, and the teeth was in Nolla stage 9 and above by radiographic examination.
- To be prepared to appear for follow-up.
Who cannot join
- Allergic to any medications or materials necessary to complete the procedures. The teeth with severe coronal defect that find to be non-restorable. The teeth with full crown restoration. The teeth with root fracture or vertical root fractures. Patients with periodontitis. Patients who are undergoing orthodontic treatment. Patients with dental dysplasia or other oral genetic disorders. Women who are pregnant or lactating, or women who plan to become pregnant in the subsequent 2 years.
- Patients with mental disorders. Patients with a history of systemic diseases that may alter immune function.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Zilong Deng, Doctor, +86-020-62787149, zldeng@yeah.net
About this study
Official title: Comparative Effectiveness of Pulpotomy and Root Canal Therapy in the Management of Mature Permanent Tooth With Irreversible Pulpits: a Randomized Controlled Non-inferiority Clinical Trial
This study is to evaluate the effectiveness of pulpotomy in mature permanent tooth with irreversible pulpits, and compare the clinical efficacy of pulpotomy and root canal therapy.
Read the detailed description
At present, root canal therapy ( RCT ) is still the main treatment for mature teeth diagnosed as irreversible pulpitis, but the teeth after RCT become non-vital, losing the immune defense mechanism and regeneration potential of pulp, which is not conducive to the long-term preservation of teeth. The traditional view is that mature permanent teeth with irreversible pulpitis are not indications for pulpotomy. However, with the deepening of pulp biology research and the availability of new pulp capping materials, the effect of pulpotomy is more predictable. Recent studies have shown that pulpotomy for irreversible pulpitis teeth can achieve good results, however, there is a lack of high-quality randomized controlled clinical studies, and the effect of pulpotomy compared with RCT studies rarely reported. Therefore, this project intends to explore the curative effect of pulpotomy on mature permanent teeth with irreversible pulpitis, and analyze the influence of age, tooth position and other factors on its curative effect, broaden the indications of pulpotomy, and establish the indications and standardized operation process of pulpotomy for mature permanent teeth with irreversible pulpitis.
- Conditions
- Irreversible Pulpitis, Mature Teeth
- Being tested
- Pulpotomy, Root Canal Therapy
- Keywords
- pulpotomy, root canal therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
The patients who are randomly assigned to the experimental group receive pulpotomy.
Root Canal TherapyProcedure or surgery
The patients who are randomly assigned to the Active Comparator group receive root canal therapy.
| Study group | Role | What they receive |
|---|---|---|
| Pulpotomy | Experimental | The removal of a small portion of the vital coronal pulp as a means of preserving the remaining coronal and radicular pulp tissues. Receives: Procedure: Pulpotomy |
| Root Canal Therapy | Active comparator | The complete removal of the vital dental pulp. Any material or combination of materials placed inside a root canal for the purpose of obturating and sealing the canal space. Receives: Procedure: Root Canal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of pulpotomy and root canal therapy
The teeth were asymptomatic. Clinical examination showed absence of clinical signs of pain and abscess or sinus tract. Radiographic assessment showed absence of periapical radiolucency.
Measured: From baseline to two years
Secondary outcomes (2)
The pulp vitality in pulpotomy group
The pulpal vitality will be assessed through pulpal response to thermal and electric pulp tests in teeth treated with pulpotomy.
Measured: From baseline to two years
Survival rate of teeth
Survival rate of teeth will be evaluated by function and clinical symptoms.
Measured: From baseline to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Jan 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhigang Guo, Doctor, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622266
- Sponsor's protocol ID
- NFEC-2022-334
- Status last verified
- Sep 2022
- First submitted
- 13 Nov 2022
- Last updated
- 18 Nov 2022
- 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 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Pulpotomy and Root Canal Therapy in the Management of Mature Permanent Tooth With Irreversible Pulpits: a Randomized Controlled Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT05622266
- Acronym / sponsor ID
- NFEC-2022-334
- Conditions
- Irreversible Pulpitis, Mature Teeth
- Keywords
- pulpotomy, root canal therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 18 Nov 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.
This study is to evaluate the effectiveness of pulpotomy in mature permanent tooth with irreversible pulpits, and compare the clinical efficacy of pulpotomy and root canal therapy.
Detailed description
At present, root canal therapy ( RCT ) is still the main treatment for mature teeth diagnosed as irreversible pulpitis, but the teeth after RCT become non-vital, losing the immune defense mechanism and regeneration potential of pulp, which is not conducive to the long-term preservation of teeth. The traditional view is that mature permanent teeth with irreversible pulpitis are not indications for pulpotomy. However, with the deepening of pulp biology research and the availability of new pulp capping materials, the effect of pulpotomy is more predictable. Recent studies have shown that pulpotomy for irreversible pulpitis teeth can achieve good results, however, there is a lack of high-quality randomized controlled clinical studies, and the effect of pulpotomy compared with RCT studies rarely reported. Therefore, this project intends to explore the curative effect of pulpotomy on mature permanent teeth with irreversible pulpitis, and analyze the influence of age, tooth position and other factors on its curative effect, broaden the indications of pulpotomy, and establish the indications and standardized operation process of pulpotomy for mature permanent teeth with irreversible pulpitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulpotomy | Experimental | Procedure: PulpotomyThe removal of a small portion of the vital coronal pulp as a means of preserving the remaining coronal and radicular pulp tissues. |
| Root Canal Therapy | Active comparator | Procedure: Root Canal TherapyThe complete removal of the vital dental pulp. Any material or combination of materials placed inside a root canal for the purpose of obturating and sealing the canal space. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Intended to participate with this study, and provide informed assent/consent. Aged 18 and 59 years. At least one mature permanent teeth diagnosed as acute pulpitis or chronic pulpitis, and the teeth was in Nolla stage 9 and above by radiographic examination.
- To be prepared to appear for follow-up.
Key exclusion criteria (2 listed)
- Allergic to any medications or materials necessary to complete the procedures. The teeth with severe coronal defect that find to be non-restorable. The teeth with full crown restoration. The teeth with root fracture or vertical root fractures. Patients with periodontitis. Patients who are undergoing orthodontic treatment. Patients with dental dysplasia or other oral genetic disorders. Women who are pregnant or lactating, or women who plan to become pregnant in the subsequent 2 years.
- Patients with mental disorders. Patients with a history of systemic diseases that may alter immune function.
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 |
|---|---|---|
| PulpotomyThe patients who are randomly assigned to the experimental group receive pulpotomy. | Procedure or surgery | Pulpotomy |
| Root Canal TherapyThe patients who are randomly assigned to the Active Comparator group receive root canal therapy. | Procedure or surgery | Root Canal Therapy |
Primary outcome
Success rate of pulpotomy and root canal therapy
Time frame: From baseline to two years
The teeth were asymptomatic. Clinical examination showed absence of clinical signs of pain and abscess or sinus tract. Radiographic assessment showed absence of periapical radiolucency.
2 secondary outcomes
The pulp vitality in pulpotomy group
Time frame: From baseline to two years
Survival rate of teeth
Time frame: From baseline to two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Zhigang Guo, Doctor principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulpotomy and Root Canal Therapy in people with Irreversible Pulpitis and Mature Teeth, run by Nanfang Hospital, Southern Medical University 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zilong Deng, Doctor (+86-020-62787149, zldeng@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of pulpotomy and root canal therapy (time frame: From baseline to two years). 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 18 Nov 2022.