Health Condition 1: K026- Dental caries on smooth surface
Conditions
Interventions
Intervention1: Pulpotomy: Pulpotomy will be performed for teeth having irreversible pulpitis (1 year)
Control Intervention1: Root canal treatment: RCT will be performed for teeth having irreversible p
Sponsors
Manipal College of Dental Sciences
Ikhlas El karim
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Patients aged 18 years or older (with a mature permanent tooth with deep caries/restorations and symptoms indicative of IRP (moderate to severe spontaneous lingering pain). Tooth is responsive to cold and EPT sensibility testing, restorable and can be adequately isolated during treatment. One tooth (molar or premolar) per patient.
Exclusion criteria
Exclusion criteria: 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, presence of apical radiolucency and patients who are pregnant or breast-feeding, any evidence of purulence or excessive bleeding that cannot be controlled with a cotton pellet with 2-4% hypochlorite for 10 minutes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 IRP; 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.Timepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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, non-defective 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 process evaluation and health economics analysis will be completed using data collected from participants at baseline and at 12 months using common agreed templates.Timepoint: 3 and 7 days and 1 year | — |
Countries
India
Contacts
Public ContactDr Rajkumar Narkedamalli
MCODS Manipal
Outcome results
None listed