Clinical and Patient-Reported Outcomes in Grade III Furcations: A Randomized Feasibility Trial With SMART Design

Abstract

Aim: To assess the feasibility of applying sequential, multiple assignment, randomized trial (SMART) design in periodontology and to assess the response of grade III furcation-involved molars to various treatments. Methods: A member of the public served as a co-investigator. Twenty participants with at least one grade III furcation-involved molar tooth were randomized to either non-surgical periodontal treatment (NSPT) or open-flap debridement (OFD). They were reassessed 6 months later, where ‘successful response’ to therapy was defined with a ‘combined outcome’ incorporating patient-reported and clinical parameters. Based on SMART principles, non-responders underwent further treatment and were followed up to 12 months. Results: All study feasibility criteria were met, except ‘planned recruitment rate’, which was slower than expected. At the 6-month review, those who underwent OFD showed a greater reduction in probing pocket depth (PPD) compared to those who received NSPT (p = < 0.01). ‘Success’ was reached by 6 out of 10 NSPT participants and by 7 out of 10 OFD participants. Non-responders were further randomized and followed up to 12 months. Conclusion: This SMART design is feasible in periodontology trials. This study demonstrates its advantages and limitations along with clinical and patient-reported data of grade III furcations treated surgically or non-surgically.