IADR Abstract Archives
Traditional or Minimal Endodontics for Symptomatic Pulpitis- Clinical Trial Protocol
Objectives: Complete pulpotomy (Cp) has been suggested as a minimally invasive treatment for the management of caries-compromised pulps. The outcome of this procedure is however uncertain when carried out by non-specialists. This trial aims to: 1) determine the clinical effectiveness of complete pulpotomy (Cp) in treating symptomatic irreversible pulpitis (IP) in mature permanent teeth in general dental practice (GDP). 2) Investigate the long -term costs and benefits of the intervention from an NHS perspective and its acceptability to both patients and general practitioners. 3) Determine the feasibility of using inflammatory biomarkers as a diagnostic and prognostic tool.
Methods: 164 patients aged ≥18years with a diagnosis of symptomatic irreversible pulpitis in a posterior tooth will be randomised to a 2-arm single-blinded clinical trial. 82 patients will receive standard care root canal treatment and 82 Biodentine Cp. Absence of clinical and radiographic signs and symptoms will determine success or failure at 12months. Treatment outcome will be followed up to 10 years post intervention. Univariate analysis and logistic regression will be conducted to determine the impact of different factors on treatment outcome. Concentration of inflammatory biomarkers will be measured within collected pulp tissue samples. A cost-effectiveness analysis and process evaluation will be untaken in parallel to the trial.
Results: The primary outcome is a composite measure of clinical and radiographic findings at 12months expressed as success or failure. Secondary outcomes include absence of pain in the immediate post-operative period, structurally integral tooth with an intact non-defective restoration at 12months, no further intervention during 12month follow-up, health economics evaluation, process evaluation and concentration of inflammatory biomarkers in pulpal tissue samples.
Conclusions: REFORM can provide evidence of the utility of a more conservative, simpler, and less costly treatment in the real world of general practice and offer insight into the application of biomarkers in pulpal diagnosis and treatment need.
Methods: 164 patients aged ≥18years with a diagnosis of symptomatic irreversible pulpitis in a posterior tooth will be randomised to a 2-arm single-blinded clinical trial. 82 patients will receive standard care root canal treatment and 82 Biodentine Cp. Absence of clinical and radiographic signs and symptoms will determine success or failure at 12months. Treatment outcome will be followed up to 10 years post intervention. Univariate analysis and logistic regression will be conducted to determine the impact of different factors on treatment outcome. Concentration of inflammatory biomarkers will be measured within collected pulp tissue samples. A cost-effectiveness analysis and process evaluation will be untaken in parallel to the trial.
Results: The primary outcome is a composite measure of clinical and radiographic findings at 12months expressed as success or failure. Secondary outcomes include absence of pain in the immediate post-operative period, structurally integral tooth with an intact non-defective restoration at 12months, no further intervention during 12month follow-up, health economics evaluation, process evaluation and concentration of inflammatory biomarkers in pulpal tissue samples.
Conclusions: REFORM can provide evidence of the utility of a more conservative, simpler, and less costly treatment in the real world of general practice and offer insight into the application of biomarkers in pulpal diagnosis and treatment need.