Efficacy Study Background

Title of Project: Conducting a Pilot Clinical Study to Evaluate the Safety and Efficacy of a Newly Developed Chemical Formula for Managing Bracket-Induced Plaque Formation

Period of Study: Fall 2017

Location: UCLA School of Dentistry Orthodontic Clinic

Funding: Partial funding support provided by the American Association of Orthodontics Foundation

Summary/Abstract

Orthodontic brackets hamper effective oral hygiene with heavy accumulation of dental plaques in the area, leading to the negative consequences such as decalcification of enamel surface (white spot lesions), caries, as well as gingival inflammation. So far, no effective methods could control the dental plaque in orthodontic patients. Thus, I specifically focused my research effort on developing new ways to inhibit bracket-induced plaque formation. My previous research led to the discovery of several anti-plaque formation chemical compounds that were formulated into toothpaste with strong inhibitory effect against bracket-induced plaque in vitro. In this study, building on the strong preliminary data, a randomized, double-blinded, placebo-controlled, pilot clinical study was conducted to evaluate the in vivo safety and efficacy of this newly formulated toothpaste on managing bracket-induced plaque formation.

As there were no safety concerns identified, the efficacy study was initiated with 28 days of newly formulated toothpaste administration. 15 patients have been recruited as treatment group with the average age of 13.6y, while 14 patients have been recruited as control group with the average age of 13.4 y.

Plaque index and gingival scores in full dentition of the participants were recorded as baseline at day 0 (Visit 0) and then were provided toothpastes. To evaluate anti-plaque effect, study subjects were recalled to the clinic and examined for bracket-induced plaque index and gingival index at day 7, 14, 28 (Visit 2-4). Results of plaque index and gingival scores were expressed as median with the interquartile range (IQR) shown in Fig. 1 and Fig. 2. Variables were compared using non-parametrical tests, Wilcoxon rank-sum test was used for paired data analysis and Mann-Whitney test was used for non-paired data. The level of significance was established at the 0.05 level (two-sided). The analysis was performed using SPSS (SPSS Inc., USA).

For patients with heavy plaque at the beginning of the study (Plaque Index >=3), we found that the difference of the gingival score on days 14 and 28 when comparing day 0 in treatment group has significant decrease compare to the placebo group on the buccal surface of teeth with bands. The test group for day 14 had a 39.3% difference compared to the placebo, which had a p-value of .0362. For day 28, it was shown even a larger difference of 42.2% with a p-value of .0107. In addition, the gingival score of day 14 on the buccal side of teeth with brackets had a 18.8% reduction for the treatment group in comparison with the placebo.

In summary, the study showed that the new formula is safe as no adverse event was observed during the entire study. On the efficacy part, when we focused on patients with heavy plaque (Plaque Index >=3), we did find statistically and clinically significant reduction in gingival scores within the treatment group, suggesting this newly formulated toothpaste could potentially increase the gingival health in orthodontic patients with heavy plaques.

Full report available here.