Pulpitis - IrreversibleNCT05964933
Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis
A study testing Complete Pulpotomy and Pulpectomy and Root Canal Treatment in people with Pulpitis - Irreversible, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This study is a randomised controlled trial for complete pulpotomy as an alternative to root canal treatment for teeth with clinical diagnosis of symptomatic irreversible pulpitis (i.e. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Complete Pulpotomy and Pulpectomy and Root Canal Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSingapore
- Study dates
- 11 Jul 2023to Dec 2027
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients aged 12 years or older
- Mature permanent tooth with deep caries/restorations
- Symptoms indicative of irreversible pulpitis (moderate to severe spontaneous lingering pain)
- Tooth is responsive to cold and electric pulp test (EPT) sensibility testing
- Tooth is restorable and can be adequately isolated during treatment
- One tooth (molar or premolar) per patient.
Who cannot join
- Teeth with active periodontal disease (pocket depth >5mm)
- Teeth indicated for elective root canal treatment for restorative purposes
- Teeth with apical periodontitis
- Patients with complex medical histories that may affect their caries experience and healing ability (immunocompromised, radiotherapy etc.)
- Patients who are unable to consent
- History of trauma to the tooth
Show all 9Show fewer
- Presence of apical radiolucency
- Patients who are pregnant or breast-feeding
- Teeth with any evidence of purulence or excessive bleeding that cannot be controlled with a cotton pellet with 2-4% hypochlorite for 10 minutes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study is a randomised controlled trial for complete pulpotomy as an alternative to root canal treatment for teeth with clinical diagnosis of symptomatic irreversible pulpitis (i.e. signs and symptoms indicative of irreversible pulpitis) conducted at the National University Centre for Oral Health Singapore (NUCOHS) Endodontic unit. Up to 70 teeth, 35 in each group, will be enrolled.
Clinical and radiographic outcome data will be collected and analysed, and a parallel cost-effectiveness analysis will also be undertaken to examine the potential costs and benefits of pulpotomy. A process evaluation will also be conducted to assess the acceptability of the intervention to both dentists and patients, while exploring the barriers and enablers to implementation.
Read the detailed description
Mature permanent teeth with deep caries/restorations and symptoms indicative of irreversible pulpitis (moderate to severe spontaneous lingering pain) will be included in the study. The teeth will be randomised to receive one of two treatments: RCT or complete pulpotomy (n=35 in each group).
Baseline clinical and radiographic data will be collected at the first visit. In addition, patients (or their guardians, if relevant) will be invited to complete the acceptability and willingness to pay questionnaires for health economics analysis at both the first visit and at 12 months from the date of completed treatment. Pain data will be collected via a pain diary after completion of treatment at days 3 and 7 post-treatment. Patients will be clinically and radiographically reviewed at 6 and 12 months from the date of completed treatment. Review clinical data collected will include the absence of pain (and details on the nature of pain, if relevant), tenderness to percussion and palpation, presence of a swelling or a sinus tract, pathological mobility, structural integrity of tooth, intact and non-defective restoration, and response to electric pulp testing (for the pulpotomy group only). Radiographic data collected will include the presence of periapical radiolucency, presence of inter-radicular radiolucency, presence of resorption, and presence of calcifications. The need for any further intervention (including details of any procedure) or any adverse events or unscheduled visits over the follow-up period will also be recorded.
Success will be defined as 1) the absence of pain indicative of irreversible pulpitis, 2) the absence of signs and symptoms indicative of acute or chronic periapical disease, and 3) the absence of radiographic evidence of failure including radiolucency or resorption. SPSS Statistical Package (IBM SPSS Statistics) will be used for all statistical analysis, with the significance level for all statistical tests set at p-value<0.05.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Complete Pulpotomy, Pulpectomy and Root Canal Treatment
- Keywords
- dental caries, deep caries, pulpotomy, root canal treatment, vital pulp therapy
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete PulpotomyProcedure or surgery
Also called Full Pulpotomy, Coronal Pulpotomy
Complete caries removal and excision of the entire coronal pulp to the level of the root canal orifices will be performed. After haemostasis, the pulp chamber will be filled with Biodentine® and a final direct restoration placed in 1 or 2 visits.
If there is no bleeding from the exposed pulp, pulpectomy and root canal treatment will be performed instead, and the patient will be excluded from the study.
Pulpectomy and Root Canal TreatmentProcedure or surgery
Also called Conventional Root Canal Treatment, Non-surgical Endodontic Treatment
After complete caries removal and pulp exposure, Pulpectomy will be performed to remove all pulp tissues. Conventional root canal treatment will be performed using rotary instrumentation followed by obturation with gutta percha and traditional sealers in 1 or 2 visits. A final restoration will be placed to ensure a good coronal seal, and this may include full coronal coverage restorations if clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Complete Pulpotomy | Active comparator | The tooth will be treated with Complete Pulpotomy. Receives: Procedure: Complete Pulpotomy |
| Pulpectomy and Root Canal Treatment | Active comparator | The tooth will be treated with Pulpectomy and Root Canal Treatment. Receives: Procedure: Pulpectomy and Root Canal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure is defined by the change from baseline pain and radiographic status at 6 months and again at 12 months.
Composite measure defined as:
- absence of pain indicative of irreversible pulpitis;
- absence of signs and symptoms indicative of acute or chronic periapical disease;
- absence of radiographic evidence of failure including radiolucency or resorption.
Measured: 6, 12 months
Secondary outcomes (6)
Numeric Rate Scale (NRS): minimum value = 0 (best outcome), maximum value = 10 (worst outcome)
A patient reported outcome of pain experienced and use of analgesia in the immediate post-operative period, collected through a Numeric Rating Scale (NRS).
Measured: 3, 7 days
Restoration: the restoration remains intact and adapts completely to the prepared cavity margins.
The presence of a structurally integral tooth with an intact, non-defective restoration.
Measured: 6, 12 months
A "yes" or "no" response when the Cold Test and Electric Pulp Test are applied on the treated tooth.
Positive sensibility response on electrical pulp test (EPT) for the Pulpotomy group only.
Measured: 6, 12 months
N5. Clinicians examine the treated tooth to determine if there is pathology that resulted from the treatment.
Absence of need for any further intervention during the follow-up period or any adverse event.
Measured: 12 months
Data to be collected include time spent on receiving the treatment, cost of treatment, and patients' willingness to pay for treatment.
A parallel process evaluation and health economics analysis will be completed using data collected from participants at baseline and at 12 months.
Measured: 12 months
Radiographic appearance of the dental pulp and its canal(s) at baseline will be compared to that at 12 months.
Radiographic evidence of pulp calcification in response to Pulpotomy (applicable to the Pulpotomy group only).
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 Jul 2023
- Study start11 Jul 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (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 National University Hospital, SingaporeThe 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
- Model description
- Study subject (tooth) will be randomized in a 1:1 allocation ratio between the two treatment groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoria Yu, PhD, Principal investigator, National University Hosptial, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964933
- Sponsor's protocol ID
- DSRB 2023/00044
- Status last verified
- May 2023
- First submitted
- 11 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT05964933
- Acronym / sponsor ID
- DSRB 2023/00044
- Conditions
- Pulpitis - Irreversible
- Keywords
- dental caries, deep caries, pulpotomy, root canal treatment, vital pulp therapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Jul 2023 (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 a randomised controlled trial for complete pulpotomy as an alternative to root canal treatment for teeth with clinical diagnosis of symptomatic irreversible pulpitis (i.e. signs and symptoms indicative of irreversible pulpitis) conducted at the National University Centre for Oral Health Singapore (NUCOHS) Endodontic unit. Up to 70 teeth, 35 in each group, will be enrolled.
Clinical and radiographic outcome data will be collected and analysed, and a parallel cost-effectiveness analysis will also be undertaken to examine the potential costs and benefits of pulpotomy. A process evaluation will also be conducted to assess the acceptability of the intervention to both dentists and patients, while exploring the barriers and enablers to implementation.
Detailed description
Mature permanent teeth with deep caries/restorations and symptoms indicative of irreversible pulpitis (moderate to severe spontaneous lingering pain) will be included in the study. The teeth will be randomised to receive one of two treatments: RCT or complete pulpotomy (n=35 in each group).
Baseline clinical and radiographic data will be collected at the first visit. In addition, patients (or their guardians, if relevant) will be invited to complete the acceptability and willingness to pay questionnaires for health economics analysis at both the first visit and at 12 months from the date of completed treatment. Pain data will be collected via a pain diary after completion of treatment at days 3 and 7 post-treatment. Patients will be clinically and radiographically reviewed at 6 and 12 months from the date of completed treatment. Review clinical data collected will include the absence of pain (and details on the nature of pain, if relevant), tenderness to percussion and palpation, presence of a swelling or a sinus tract, pathological mobility, structural integrity of tooth, intact and non-defective restoration, and response to electric pulp testing (for the pulpotomy group only). Radiographic data collected will include the presence of periapical radiolucency, presence of inter-radicular radiolucency, presence of resorption, and presence of calcifications. The need for any further intervention (including details of any procedure) or any adverse events or unscheduled visits over the follow-up period will also be recorded.
Success will be defined as 1) the absence of pain indicative of irreversible pulpitis, 2) the absence of signs and symptoms indicative of acute or chronic periapical disease, and 3) the absence of radiographic evidence of failure including radiolucency or resorption. SPSS Statistical Package (IBM SPSS Statistics) will be used for all statistical analysis, with the significance level for all statistical tests set at p-value<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Study subject (tooth) will be randomized in a 1:1 allocation ratio between the two treatment groups.
| Arm | Type | Receives |
|---|---|---|
| Complete Pulpotomy | Active comparator | Procedure: Complete PulpotomyThe tooth will be treated with Complete Pulpotomy. |
| Pulpectomy and Root Canal Treatment | Active comparator | Procedure: Pulpectomy and Root Canal TreatmentThe tooth will be treated with Pulpectomy and Root Canal Treatment. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 12 years or older
- Mature permanent tooth with deep caries/restorations
- Symptoms indicative of irreversible pulpitis (moderate to severe spontaneous lingering pain)
- Tooth is responsive to cold and electric pulp test (EPT) sensibility testing
- Tooth is restorable and can be adequately isolated during treatment
Key exclusion criteria (9 listed)
- Teeth with active periodontal disease (pocket depth >5mm)
- Teeth indicated for elective root canal treatment for restorative purposes
- Teeth with apical periodontitis
- Patients with complex medical histories that may affect their caries experience and healing ability (immunocompromised, radiotherapy etc.)
- Patients who are unable to consent
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 |
|---|---|---|
| Complete PulpotomyAlso: Full Pulpotomy, Coronal PulpotomyComplete caries removal and excision of the entire coronal pulp to the level of the root canal orifices will be performed. After haemostasis, the pulp chamber will be filled with Biodentine® and a final direct restoration placed in 1 or 2 visits. If there is no bleeding from the exposed pulp, pulpectomy and root canal treatment will be performed instead, and the patient will be excluded from the study. | Procedure or surgery | Complete Pulpotomy |
| Pulpectomy and Root Canal TreatmentAlso: Conventional Root Canal Treatment, Non-surgical Endodontic TreatmentAfter complete caries removal and pulp exposure, Pulpectomy will be performed to remove all pulp tissues. Conventional root canal treatment will be performed using rotary instrumentation followed by obturation with gutta percha and traditional sealers in 1 or 2 visits. A final restoration will be placed to ensure a good coronal seal, and this may include full coronal coverage restorations if clinically indicated. | Procedure or surgery | Pulpectomy and Root Canal Treatment |
Primary outcome
Composite measure is defined by the change from baseline pain and radiographic status at 6 months and again at 12 months.
Time frame: 6, 12 months
Composite measure defined as: 1. absence of pain indicative of irreversible pulpitis; 2. absence of signs and symptoms indicative of acute or chronic periapical disease; 3. absence of radiographic evidence of failure including radiolucency or resorption.
6 secondary outcomes
Numeric Rate Scale (NRS): minimum value = 0 (best outcome), maximum value = 10 (worst outcome)
Time frame: 3, 7 days
Restoration: the restoration remains intact and adapts completely to the prepared cavity margins.
Time frame: 6, 12 months
A "yes" or "no" response when the Cold Test and Electric Pulp Test are applied on the treated tooth.
Time frame: 6, 12 months
N5. Clinicians examine the treated tooth to determine if there is pathology that resulted from the treatment.
Time frame: 12 months
Data to be collected include time spent on receiving the treatment, cost of treatment, and patients' willingness to pay for treatment.
Time frame: 12 months
Radiographic appearance of the dental pulp and its canal(s) at baseline will be compared to that at 12 months.
Time frame: 12, months
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 28 Jul 2023.
- 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.
Victoria Yu, PhD principal investigator
National University Hosptial, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete Pulpotomy and Pulpectomy and Root Canal Treatment in people with Pulpitis - Irreversible, run by National University Hospital, Singapore at 1 site in Singapore.
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 6 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 28 Jul 2023. 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 Singapore. 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?
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?
Composite measure is defined by the change from baseline pain and radiographic status at 6 months and again at 12 months. (time frame: 6, 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 28 Jul 2023.