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

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.