Extremely Deep CariesNCT07242742
Effectiveness of Pulpotomy vs. Root Canal Treatment in Extremely Deep Caries
A study testing Full Pulpotomy and root canal treatment and intracanal medicament in people with Extremely Deep Caries and Pulpitis, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Recent clinical trials comparing pulpotomy versus root canal treatment (RCT) have shown promising outcomes; however, the current evidence lacks generalisability to general practitioners. It remains to be elucidated whether these favourable results can be replicated in a primary care setting. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Extremely Deep Caries, Pulpitis
- What is being tested?
- Full Pulpotomy and root canal treatment and intracanal medicament
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteSingapore
- Study dates
- 16 Jul 2025to Jul 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 12 years or older
- Mature maxillary or mandibular permanent tooth with extremely deep restorations/caries penetrating the entire thickness of dentine on the radiograph without a radiopaque zone separating the lesion from the pulp (Bjorndal et al., 2019)
- Tooth may or may not be symptomatic at the time of recruitment but must be responsive to cold and EPT sensibility testing
- Tooth is restorable and can be adequately isolated during treatment
- One tooth per patient
Who cannot join
- Teeth with difficult access and unpredictable isolation using a rubber dam
- Teeth aberrant root canal morphology, extreme root curvatures (>30 degrees), calcified canals/sclerosed pulp
- Teeth indicated for elective root canal treatment for restorative purposes
- Teeth with apical periodontitis
- Presence of apical radiolucency
- Any evidence of purulence or excessive bleeding that cannot be controlled with a cotton pellet with 1.25% hypochlorite for 10 minutes
Show all 11Show fewer
- History of trauma to the tooth
- Teeth with active periodontal disease (pocket depth >5mm)
- Patients with complex medical histories that may affect their caries experience and healing ability (immunocompromised, radiotherapy etc.)
- Patients who are pregnant or breast-feeding
- Patients who are unable to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National University Centre For Oral Health Singapore (NUCOHS)
Singapore
Victoria Yu Associate Professor, (65) 9004 1044, denyshv@nus.edu.sg
Victoria Yu, PhD
About this study
Official title: Effectiveness of Pulpotomy vs. Root Canal Treatment in Extremely Deep Caries: A Randomized Controlled Trial Conducted in Supervised Undergraduate Clinics
Recent clinical trials comparing pulpotomy versus root canal treatment (RCT) have shown promising outcomes; however, the current evidence lacks generalisability to general practitioners. It remains to be elucidated whether these favourable results can be replicated in a primary care setting. This study aims to address that gap by involving senior dental students undergoing supervised university education and training, with the potential to inform future best practice guidelines and promote the adoption of vital pulp therapy (VPT) as a predictable treatment alternative in the general dental population.
The clinical procedure involves complete caries-free excavation carried out under rubber dam isolation. After confirming vital pulp status-demonstrated by bleeding upon entry, participants will be randomised to receive one of two treatments: RCT or full pulpotomy.
Outcomes will include clinical and radiographic success or failure of the intervention at 12 months. Additionally, patient-reported outcomes will be collected, specifically pain experienced and the use of analgesia during the immediate post-operative period (days 3 and 7).
- Conditions
- Extremely Deep Caries, Pulpitis
- Being tested
- Full Pulpotomy, root canal treatment and intracanal medicament
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full PulpotomyProcedure or surgery
Preservation of vital pulp tissue for tooth survival.
root canal treatment and intracanal medicamentProcedure or surgery
Root canal treatment as a comparator to pulpotomy.
| Study group | Role | What they receive |
|---|---|---|
| Full Pulpotomy | Experimental | The intra-operative standard care for pulpotomy is as follows:
* Clinical procedure should be completed over one or 2 visits
* Performed under local anaesthesia and rubber dam isolation
* Complete caries removal
* Pulp resection using sterile high-speed bur with water coolant
* Irrigation protocol with 1.25% sodium hypochlorite
* Haemostasis with a 1.25% sodium hypochlorite-moistened cotton pellet over the amputated pulps for up to 10 minutes
* Placement of Biodentine (Septodont Ltd., Saint Maur des Fausse s, France) or its alternative approved by NUCOHS for pulpotomy
* Final definitive resin-based restoration
* Post-operative periapical radiograph taken Receives: Procedure: Full Pulpotomy |
| Root Canal Treatment | Active comparator | The intra-operative standard care for root canal treatment is as follows:
* Clinical procedure can be carried out over one or 2 visits
* Use of rubber dam mandatory
* Irrigation protocol with 1.25% sodium hypochlorite
* Working length with combined radiographs and apex locators
* Automated instrumentation to accompany hand instrumentation
* Preparation to apical size 2-3 larger than largest file that binds at the WL in the uninstrumented canal initial apical file (IAF)
* Canal medicament; non setting calcium hydroxide if done in two visits
* Root canal filling with gutta pecha and traditional sealers (cold lateral or warm vertical condensation)
* Ensure coronal seal
* Good quality postoperative radiograph using parallel cone technique
* Final restoration as per undergraduate clinical protocols Receives: Procedure: root canal treatment and intracanal medicament |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Clinical and radiographic success or failure of the intervention will be measured at 12 months. The primary outcome is a composite measure at 12 months: 1) absence of pain indicative of unhealthy pulp; 2) absence of signs and symptoms indicative of acute or chronic periapical disease; 3) absence of radiographic evidence of failure including radiolucency or resorption. Failure of any part of the composite, at or any time before 12 months, will equate to overall treatment failure.
Measured: 12 months
Secondary outcomes (1)
Secondary Outcome
A patient reported outcome of pain experienced and use of analgesia in the immediate post-operative period (days 3, 7) will be collected through a paper questionnaire distributed at visit 1. The presence of a structurally integral tooth with an intact, nondefective restoration at 12 months, with positive sensibility response to EPT and with absence of need for any further intervention during the 12-month follow-up period, presence of calcification or adverse event will be reported on. A parallel health economics analysis will be completed using data collected from participants at baseline and at 12 months using common agreed templates.
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 posted21 Nov 2025
- Study start16 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extremely Deep CariesStudies 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242742
- Sponsor's protocol ID
- 2024-4505
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only anonymised data can be shared, subject to local health records governance.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pulpotomy vs. Root Canal Treatment in Extremely Deep Caries: A Randomized Controlled Trial Conducted in Supervised Undergraduate Clinics
- ClinicalTrials.gov ID
- NCT07242742
- Acronym / sponsor ID
- 2024-4505
- Conditions
- Extremely Deep Caries, Pulpitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 21 Nov 2025 (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.
Recent clinical trials comparing pulpotomy versus root canal treatment (RCT) have shown promising outcomes; however, the current evidence lacks generalisability to general practitioners. It remains to be elucidated whether these favourable results can be replicated in a primary care setting. This study aims to address that gap by involving senior dental students undergoing supervised university education and training, with the potential to inform future best practice guidelines and promote the adoption of vital pulp therapy (VPT) as a predictable treatment alternative in the general dental population.
The clinical procedure involves complete caries-free excavation carried out under rubber dam isolation. After confirming vital pulp status-demonstrated by bleeding upon entry, participants will be randomised to receive one of two treatments: RCT or full pulpotomy.
Outcomes will include clinical and radiographic success or failure of the intervention at 12 months. Additionally, patient-reported outcomes will be collected, specifically pain experienced and the use of analgesia during the immediate post-operative period (days 3 and 7).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Pulpotomy | Experimental | Procedure: Full PulpotomyThe intra-operative standard care for pulpotomy is as follows: * Clinical procedure should be completed over one or 2 visits * Performed under local anaesthesia and rubber dam isolation * Complete caries removal * Pulp resection using sterile high-speed bur with water coolant * Irrigation protocol with 1.25% sodium hypochlorite * Haemostasis with a 1.25% sodium hypochlorite-moistened cotton pellet over the amputated pulps for up to 10 minutes * Placement of Biodentine (Septodont Ltd., Saint Maur des Fausse s, France) or its alternative approved by NUCOHS for pulpotomy * Final definitive resin-based restoration * Post-operative periapical radiograph taken |
| Root Canal Treatment | Active comparator | Procedure: root canal treatment and intracanal medicamentThe intra-operative standard care for root canal treatment is as follows: * Clinical procedure can be carried out over one or 2 visits * Use of rubber dam mandatory * Irrigation protocol with 1.25% sodium hypochlorite * Working length with combined radiographs and apex locators * Automated instrumentation to accompany hand instrumentation * Preparation to apical size 2-3 larger than largest file that binds at the WL in the uninstrumented canal initial apical file (IAF) * Canal medicament; non setting calcium hydroxide if done in two visits * Root canal filling with gutta pecha and traditional sealers (cold lateral or warm vertical condensation) * Ensure coronal seal * Good quality postoperative radiograph using parallel cone technique * Final restoration as per undergraduate clinical protocols |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 12 years or older
- Mature maxillary or mandibular permanent tooth with extremely deep restorations/caries penetrating the entire thickness of dentine on the radiograph without a radiopaque zone separating the lesion from the pulp (Bjorndal et al., 2019)
- Tooth may or may not be symptomatic at the time of recruitment but must be responsive to cold and EPT sensibility testing
- Tooth is restorable and can be adequately isolated during treatment
- One tooth per patient
Key exclusion criteria (11 listed)
- Teeth with difficult access and unpredictable isolation using a rubber dam
- Teeth aberrant root canal morphology, extreme root curvatures (>30 degrees), calcified canals/sclerosed pulp
- Teeth indicated for elective root canal treatment for restorative purposes
- Teeth with apical periodontitis
- Presence of apical radiolucency
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 PulpotomyPreservation of vital pulp tissue for tooth survival. | Procedure or surgery | Full Pulpotomy |
| root canal treatment and intracanal medicamentRoot canal treatment as a comparator to pulpotomy. | Procedure or surgery | Root Canal Treatment |
Primary outcome
Primary Outcome
Time frame: 12 months
Clinical and radiographic success or failure of the intervention will be measured at 12 months. The primary outcome is a composite measure at 12 months: 1) absence of pain indicative of unhealthy pulp; 2) absence of signs and symptoms indicative of acute or chronic periapical disease; 3) absence of radiographic evidence of failure including radiolucency or resorption. Failure of any part of the composite, at or any time before 12 months, will equate to overall treatment failure.
1 secondary outcome
Secondary Outcome
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 21 Nov 2025.
- Individual participant dataSharing planned: Yes. Only anonymised data can be shared, subject to local health records governance.
Related trials for Extremely Deep Caries
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"The Relationship Between Pulpal Inflammatory Marker Levels in Moderate and Severe Pulpitis and Outcome of Full Pulpotomy in Mandibular Molars With Extremely Deep Caries: A Prospective Cohort Study."
Moderate Severe Pulpitis, Extremely Deep Caries
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Outcome of Partial Pulpotomy in Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis After Wound Lavage With Calcium Hypochlorite or Sodium Hypochlorite
Symptomatic Irreversible Pulpitis (SIP), Extremely Deep Caries
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Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars .
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Influence of Proximal Caries on Outcome of Direct Pulp Capping in Permanent Mandibular Molars With Reversible Pulpitis
Reversible Pulpitis, Extremely Deep Caries
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Outcomes of Pulpotomy and Root Canal Treatment in Teeth With Symptomatic Irreversible 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.
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 and intracanal medicament in people with Extremely Deep Caries and Pulpitis, 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 5 inclusion and 11 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 21 Nov 2025. 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?
Contact Victoria Yu ((65) 9004 1044, denyshv@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (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 21 Nov 2025.