Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full Pulpotomy | Experimental | The intra-operative standard care for pulpotomy is as follows:
|
|
| Root Canal Treatment | Active Comparator | The intra-operative standard care for root canal treatment is as follows:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full Pulpotomy | Procedure | Preservation of vital pulp tissue for tooth survival. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria Yu | Contact | (65) 9004 1044 | denyshv@nus.edu.sg |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Centre For Oral Health Singapore (NUCOHS) | Recruiting | Singapore | Singapore |
Only anonymised data can be shared, subject to local health records governance.
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011671 | Pulpitis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
care providers and participants are masked at the start of caries removal and up to the stage of random allocation to pulpotomy or root canal treatment.
| root canal treatment and intracanal medicament |
| Procedure |
Root canal treatment as a comparator to pulpotomy. |
|
| 12 months |