A randomized clinical trial for the clinical efficacy evaluation of dental plaque disclosing agents

Purpose: The aim of this study is to assess the local irritation, disclosing efficacy, and ease of removal of dental plaque disclosing agents (PDAs) containing various colorants through clinical investigation.Materials and Methods: Four types of PDAs (A: Hellotis<sup>TM</sup> solution, B: Trace<sup>TM</sup> solution, C: 2Tone<sup>TM</sup> solution, D: PlaqSearch<sup>TM</sup> two-tone tablet) were sequentially applied to 40 subjects at weekly intervals. Oral pain and gingival index were evaluated for local irritation assessment, while dental plaque index was assessed for efficacy.Results: The incidence rate of pain was not significantly different between groups (P>0.05). No changes in the Loe & Silness Gingival Index were observed in any PDA group after 1 week of application (P>0.05). The Patient Hygiene Performance Index (PHP Index) for each plaque disclosing agent was ranked as B > C > A > D, with B having the highest staining ability. A statistically significant difference was observed between B and D (P<0.05). As a result of the equivalence test, A and C, A and D, and B and C were equivalent when the margin of clinical equivalence (△) was set to 0.5. There was no difference in the removal rate between the PDA groups (P>0.05).Conclusion: The clinical study illustrated that plaque disclosing agents, including the Hellotis<sup>TM</sup>, efficiently stained plaque and were easily removed by brushing. No side effects were observed concerning oral pain or changes in gingival health following the application of the PDAs.