Traditional root canal or minimally invasive pulpotomy treatment for managing painful carious teeth in general dental practice

Not Applicable

• Conditions: Conservative treatment of irreversible pulpitis in adult patients in pre/molar teeth; Oral Health

• Registration Number: ISRCTN49302282
• Lead Sponsor: Queen's University Belfast

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-17
• Last Update Posted: 4 December 2023
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

1. Patients 18 years or older with symptoms of irreversible pulpitis affecting a permanent posterior tooth. Symptomatic irreversible pulpitis may include sharp pain upon thermal stimulus, lingering pain, spontaneity (unprovoked pain) and referred pain (AAE 2017)
2. Tooth should be responsive to sensibility tests
3. Tooth should be restorable and can be adequately isolated during treatment

Exclusion Criteria

1. Teeth with active periodontal disease (pocket depth >5 mm)
2. Participants with complex medical histories that may affect their caries experience and healing ability
3. Inability to provide consent
4. History of trauma to tooth
5. Presence of apical radiolucency or ligament enlargement on radiograph
6. Pregnant or breast-feeding patient

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success or failure of the composite outcome measure at 12 months. Success will be defined as achieving all three criteria and failure of any single criteria within the composite will indicate a treatment failure: absence of pain, absence of swelling or sinus around the tooth indicative of acute or chronic periapical infection, no evidence of periapical radiolucency or internal root resorption confirmed by history, clinical examination and radiographic assessment.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Absence of pain measured using a numeric rating scale (NRS) on days 3 and 7 postoperatively<br> 2. Structural integrity of tooth defined as an intact, non-defective restoration at 12 months<br> 3. No further interventions or adverse events using patient records during the 12-month follow-up period<br> 4. A health economic evaluation to include incremental cost-effectiveness analysis at 12 months<br> 5. Process evaluation (patients' and practitioners' satisfaction with the procedure) and identification of facilitators and barriers over 12 months<br> 6. Concentration of inflammatory biomarkers collected from infected pulp tissue samples and measured using ELISA at baseline<br>