Aim: To assess the efficacy of a commercially available adjunctive phototherapy protocol ("Perio-1") in treatment of periodontitis.
Materials and Methods:In an examiner-blind, randomized, controlled, split-mouth, multicentre study, 60 periodontitis patients received root surface debridement (RSD) in sextants either alone (control sextants) or with the adjunctive phototherapy protocol (test sextants). Re-evaluation was performed at 6, 12 and 24 weeks.
Results:No statistically significant differences in mean (± standard deviation) clinical attachment level (CAL) change from baseline to week 24 were observed between test (−1.00 ± 1.16 mm) and control sextants (−0.87 ± 0.79 mm) at sites with probing pocket depths (PPDs) ≥5 mm ("deep sites") at baseline (p = .212). Comparisons between test and control sextants for all other parameters (CAL change at all sites, PPD change at deep sites/all sites, bleeding on probing, plaque scores), and for all change intervals, failed to identify any statistically significant differences.
Conclusions:The phototherapy protocol did not provide any additional clinical benefits over those achieved by RSD alone. (German Clinical Trials Register DRKS00011229).
K E Y W O R D Speriodontal debridement, periodontitis, phototherapy, randomized controlled trial
Clinical RelevanceScientific rationale for the study: An adjunctive phototherapy protocol ("Perio-1") is available for treatment of periodontitis. However, there is a lack of evidence regarding the clinical efficacy of the protocol.Principal findings: Sextants treated with root surface debridement (RSD) plus the adjunctive phototherapy protocol did not demonstrate better clinical outcomes compared to sextants treated with RSD alone.
Practical implications:The findings of this research do not support use of the phototherapy protocol in the treatment of periodontitis. It is important that properly designed studies that investigate mechanisms of action and clinical efficacy are performed prior to new technologies being