The effect of active oxygen-containing toothpaste on Streptococcus mutans and white spot lesions: An in-vivo randomized controlled trial

Abstract

Fixed appliances limit patients' ability to clean their teeth, thus making orthodontic patients highly susceptible to developing white spot lesions (WSLs). Using patient compliance would be one of the simplest methods to prevent WSLs. A parallel trial design with 34 patients that met the eligibility criteria were randomized to experimental (received Blue M oxygen for health toothpaste) and control (received Colgate Total fluoridated toothpaste) groups. The eligibility criteria were that the patients should be aged 13-30 years, on fixed mechanotherapy, had undergone therapeutic extraction of all first premolars, had completed leveling and aligning, and had satisfactory oral hygiene (assessed using pretreatment and current Simplified Oral Hygiene Index scores). The objectives were to assess the effects of active oxygen-containing toothpaste on Streptococcus mutans (SM) and WSLs in patients undergoing fixed mechanotherapy. The random allocation sequence was generated using the RAND function in Microsoft Excel. The sequence generated was sealed in opaque white envelopes. The investigators and the participants were blinded until allocation. Blinding of the first author (J.A.G.) who dispensed the toothpaste or the participants was not possible. The outcome assessment was blinded by coding the plaque specimens sent for real-time polymerase chain reaction (RT-PCR) to ensure that the final data assessment was blinded. The study setting was the Department of Orthodontics and Dentofacial Orthopedics, Sri Ramachandra Institute of Higher Education and Research (SRIHER) University. The primary outcome was SM counts, which were analyzed using RT-PCR. The secondary outcome was WSL assessment, performed using DIAGNOdent and International Caries Detection and Assessment System (ICDAS) II criteria at baseline and after 4 weeks. The data were subjected to statistical analysis. Thirty-four patients were randomized to 17 per group and analyzed. RT-PCR showed lower SM in the experimental group (Ct= 32.25 ± 10.6) than in the control group (Ct= 30.9 ± 10.49). However, this was not statistically significant (P= 0.70). ICDAS scores remained the same from baseline and after 4 weeks for both groups. The DIAGNOdent values were in tandem with the ICDAS scores and showed minimal change for the 2 groups (P>0.05). A strong positive correlation was observed for DIAGNOdent and ICDAS scores (τb>0.30). No harms or adverse effects were observed or reported by the patients during the experimental period. The active oxygen-containing toothpaste showed a greater inhibitory effect on SM than the fluoridated toothpaste. However, this effect was minimal. Both kinds of toothpaste showed negligible effects on WSLs. Thus, active oxygen-containing toothpaste is as effective as fluoridated toothpaste. The Trial was registered in the Controlled Trials Registry India (CTRI/2021/10/037458). The full protocol can be obtained from any of the authors via e-mail. The project was self-funded.