الفهرس 
Evaluation of remineralization potential of preventive regimens containing herbal based compared to fluoride based toothpastes in high caries risk patients with initial carious lesions: A Randomized Clinical Trial
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Abstract
This study was conducted to assess the effect of preventive regimens using herbal or fluoride toothpastes on remineralization of initial carious lesions and caries risk in high caries risk patients.
Material and methods: Two parallel armed group, triple blinded, randomized, controlled trial. The study was carried out on 32 participants with high caries risk and 32 initial carious lesions at their smooth surfaces. Participants were separated randomly into two groups, 16 participants each. According to the test regimen, where (A1) participants were exposed to a regimen including herbal based toothpaste (Himalaya complete care) and (A2) participants were exposed to a regimen including fluoride based toothpaste (Colgate cavity protection). The research study was conducted over a three-month period, assessment of remineralization of initial carious lesions were evaluated by diagnodent at T0: baseline, T1: one week and T3: after 12 weeks follow up periods, visual examination of initial lesions was evaluated by International Caries Detection and Assessment System (ICDAS) scoring system at T0: baseline and T3: 12 weeks follow up periods, and percentage to avoid new lesions by cariogram at T0: baseline, T1: one week, T2: four weeks, and T3: 12 weeks follow up periods.
Results: statistical methods: Data will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 25 (SPSS Inc., Chicago, IL). Categorical data will be described as absolute risk for each intervention independently and relative risk when comparing
both interventions. Comparisons between categorical variables will be performed using the chi square test and Kruskal Wallis will be used to test interaction of variables. Continuous data will be described using mean and standard deviation. Comparison between continuous data will be performed using t-test and two-way ANOVA will be used to test interaction of variables. A p-value less than or equal to 0.05 will be considered statistically significant and all tests will be two tailed.
According to diagnodent there was no statistically significant difference throughout the follow-up phases; baseline and 1 week (P = 0.6669), while at 3 months’ intergroup comparison revealed statistically significant difference (P=0.0155), intragroup comparison within Himalaya or
Colgate have proven that there is a statistically significant difference between the various follow-up times (P < 0.0001). According to ICDAs within the varied follow-up periods, there was no statistical difference; baseline and 3 months respectively (P = 0.1506 and P = 0.7273), intragroup comparison within Himalaya have shown statistically significant difference between different follow-up periods (P = 0.0159*). Within Colgate, intragroup comparisons revealed no significant differences between different follow-up periods (P = 0.1506). However, cariogram (chance to avoid new lesions) during follow-up periods, an intergroup analysis of both components revealed no statistically significant differences; baseline,1 week, 1 month and 3 months (P = 0.3282, P = 0.3282, P = 0.4817 and P = 0.8565) respectively. Intragroup comparison within Himalaya or Colgate have shown statistically significant difference between different follow-up periods (P < 0.0001)
Conclusion: Preventive regimens containing different toothpastes are positively influencing caries prevention and remineralization potential of initial carious lesions in high caries risk patients, while herbal based toothpaste was superior along three months follow up. Different preventive regimens didn’t produce significant effect in altering visual appearance of initial carious lesions.