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

TRaditional or minimally invasive Endodontics FOr managing caRious teeth with syMptomatic pulpitis- a pragmatic randomised trial in general dental practice in Northern Ireland

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN49302282

Enrollment

164

Registered

2021-08-17

Start date

2021-09-23

Completion date

Unknown

Last updated

2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conservative treatment of irreversible pulpitis in adult patients in pre/molar teeth Oral Health

Interventions

164 patients aged 18 years or older with a diagnosis of irreversible pulpitis affecting a permanent posterior tooth will be randomised to one of two treatment arms- traditional root canal treatment or

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

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

Measure

Time frame

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

—

Countries

United Kingdom

Contacts

Public ContactSiobhan Cushley

s.cushley@qub.ac.uk+44 (0)7860707782

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026