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Randomized Controlled Trial
. 2022 Aug;8(4):863-874.
doi: 10.1002/cre2.559. Epub 2022 Apr 14.

Aragonite toothpaste for management of dental calculus: A double-blinded randomized controlled clinical trial

Affiliations
Randomized Controlled Trial

Aragonite toothpaste for management of dental calculus: A double-blinded randomized controlled clinical trial

Ashwaq A Al-Hashedi et al. Clin Exp Dent Res. 2022 Aug.

Erratum in

Abstract

Objectives: Aragonite from animal origin such as cuttlefish bone powder is an abrasive with hardness properties ideal for calculus removal. The purpose of this randomized controlled trial was to test the efficacy of a cuttlebone-derived aragonite toothpaste in removing dental calculus.

Materials and methods: Eighty-one patients who fulfilled the inclusion criteria were blindly and randomly assigned into two study groups. The intervention treatment group (n = 40) received cuttlebone toothpaste (Dr. D-Tart) and the control group (n = 41) received an off-the-shelf commercial toothpaste (Crest). Evaluations were performed before and after scaling and polishing procedures done at 3 months in order to evaluate the toothpaste's ability to remove calculus and to prevent calculus formation. Calculus, stains, plaque, and gingival indices scores, and patient satisfaction surveys were compared at baseline (first visit), 3, and 9 months, using generalized linear models and Wald's χ2 test.

Results: At the end of the 3-month period, the intervention group showed a 30% reduction in total calculus compared to the baseline score (p = .0006) and 45% less total calculus compared to the control group (p = .0001). Six months after scaling, the mean calculus score for Crest users was 42% higher than that for Dr. D-Tart users (p = .0692). There was a significant improvement in the gingival health of cuttlebone toothpaste users at the observed intervals, and both kinds of toothpaste achieved comparable results in terms of plaque and stains removal.

Conclusions: Aragonite toothpaste can remove calculus, prevent calculus formation, and improve gingival health. Patients are generally satisfied with the performance of the aragonite toothpaste.

Clinical significance: Animal-derived aragonite toothpaste (Dr. D-Tart) shows promising efficacy in removing calculus, preventing calculus formation, and for the improvement of gingival health.

Clinical trial id: A08-M35-16B.

Keywords: aragonite; dental calculus; oral hygiene; toothpaste.

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Conflict of interest statement

Dr. Faleh Tamimi has aquired shares in the company that developed the aragonite toothpaste described in this study, Visionaturalab Inc. Also, this study was financially supported by Visionaturalab Inc., which is the company that developed the aragnoite toothpaste described in the study.

Figures

Figure 1
Figure 1
Flowchart showing the study design. QHI, Quigley–Hain Plaque Index; VM, Volpe–Manhold
Figure 2
Figure 2
(a) Demographic data of two study groups at baseline, showing gender, age, and ethnic group. Values are expressed as the number and percent of subjects in each group. (b) Bar charts illustrating the comparison of clinical indices scores in the study groups after assigning them to the Crest and Dr. D‐Tart toothpastes (baseline). Scores are expressed as means ± standard errors of the means. No significant differences between study groups were observed
Figure 3
Figure 3
Photographs showing the labial/lingual aspects of lower anterior teeth and bar charts comparing the changes in clinical indices scores in the study groups (Crest and Dr. D‐Tart toothpastes) after 3 months of toothpaste usage. Scores are expressed as means ± standard errors of the means. *Significantly different from baseline score, before using the toothpaste (p < .05). Brackets indicate significant differences between groups (p < .05).
Figure 4
Figure 4
Bar charts comparing the clinical indices scores in the study groups (Crest and Dr. D‐Tart toothpastes) 6 months after scaling (9‐month time point). Scores are expressed as means ± standard errors of the means. The brackets indicate significant differences between the Crest and Dr. D‐Tart groups (p < .05)
Figure 5
Figure 5
(a) Analysis of comments by patients and (b) results of patient satisfaction survey at month 9. Brackets indicate significant differences between groups at each time interval (p < .05). Statistical analysis was done with Student's test. CAB, cannot be determined; CI, confidence interval; VAS, visual analog scale
Figure 6
Figure 6
(a) Results of the survey on Dr. D‐Tart toothpaste for the different questions at different timepoints. No significant correlations between the question scores and the timepoints and no significant differences between time points were found. (b) Results of the survey on Crest toothpaste for the different questions at different timepoints. Bracket indicates statistically significant difference (p < .05) between timepoints. Statistical analysis was done with one‐way analysis of variance with post hoc Bonferroni test. Significant Pearson's correlation coefficients are presented as insets in the graphs

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