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Title Hydroxyapatite Toothpaste Is as Effective as Fluoride Toothpaste in Preventing the Development of caries Lesions
Clinical Question For a patient seeking to prevent dental caries, would hydroxyapatite toothpaste be as effective as fluoride toothpaste in preventing the development of enamel caries?
Clinical Bottom Line Fluoride-free hydroxyapatite toothpaste has been shown to be as effective as standard fluoride toothpaste in preventing the development of caries lesions. Recent randomized controlled trials showed that hydroxyapatite toothpaste can prevent the formation and progression of enamel caries lesions in primary teeth as well as in patients at high caries risk.
Best Evidence (you may view more info by clicking on the PubMed ID link)
PubMed ID Author / Year Patient Group Study type
(level of evidence)
#1) 30701704Schlagenhauf/2019147 subjects (11-25 y/o) who were scheduled for orthodontic therapy with fixed appliancesRandomized Controlled Trial
Key resultsAfter 168 days of the orthodontic patients using their assigned dentifrices (10% microcrystalline hydroxyapatite [HAP] or 1400ppm fluoride toothpaste) non-inferiority testing (Δ ≤ 20% margin and 95% CI) demonstrated the absence of a significant difference between the groups. With per protocol (PP) analysis, 54.7% of the subjects using HAP toothpaste and 61.6% of the fluoride control group had at least one new enamel caries, ICDAS code ≥ 1 (primary outcome). For secondary outcome measure (ICDAS code ≥ 2), 23.4% of the subjects using HAP toothpaste had at least one caries lesion compared to 34.8% in the fluoride group, and this was not a significant difference.
#2) 33514787Paszynska/2021207 children (3-7 y/o) randomly assigned a fluoride or a hydroxyapatite toothpasteRandomized Controlled Trial
Key resultsAfter 336 days of using either 10% HAP or 500 ppm fluoride toothpaste, non-inferiority testing (Δ ≤ 20% margin and 95% CI) demonstrated no statistically significant difference among the groups with respect to caries progression. With PP analysis, the development of enamel caries lesions of ICDAS code ≥ 1 or the progression of an existing enamel caries lesion by at least one ICDAS code was observed in 72.7% of the subjects using HAP toothpaste and 74.2% of the subjects using fluoride control toothpaste.
Evidence Search (enamel caries OR incipient caries OR initial carious lesion) AND hydroxyapatite (toothpaste OR dentifrice) AND fluoride AND (prevention OR development OR progression)
Comments on
The Evidence
Validity: Both clinical trials were multicenter, randomized, controlled, and conducted in a double blind manner. In both studies caries assessment was performed using the International Caries Detection and Assessment System (ICDAS) II criteria. In Schlagenhauf/2019, the subjects were equally randomized in two groups (test [HAP] and control [fluoride]). The subjects were healthy adolescents and young adults between 11 - 25 years old that underwent orthodontic treatment with fixed appliances for at least 6 months (high risk of caries). The examiners were calibrated with substantial agreement (mean weighted kappa for interrater reliability k=0.80). The subjects were advised to brush their teeth twice a day with the assigned product. There was adequate follow-up (8 visits) and measures were taken to guarantee subject compliance. Analysis of the per-protocol and intention-to-treat datasets were performed, with both showing similar results. From 147 subjects that were randomized, 133 completed the study. In Paszynska/2021 children between 3 – 7 years old were randomized equally in two groups (HAP and Fluoride). In this study, the enamel surfaces of primary molars were assessed (ICDAS II criteria). Examiner calibrations were performed to ensure inter-examiner reliability (final agreement k=0.92). The subjects should have their teeth brushed twice a day by their parents and once a day by themselves. There was adequate follow-up (6 visits) and measures were taken to guarantee subject compliance. From 214 randomized patients, 207 entered the ITT analyses and 177 entered the PP analyses, with both analyses showing similar results.
Applicability These two recent randomized controlled clinical trials demonstrate that HAP toothpaste can be an option for patients and dental care providers that are seeking an alternative to fluoride toothpaste. These clinical trials complement each other due to the fact that Schlagenhauf/2019 was performed in young adults at high caries risk indicating that it can also be used to prevent caries in patients at low and moderate caries risk status. Paszynska/2021 showed the efficacy of HAP toothpaste in primary teeth that led us to a conclusion that it can be used to prevent caries in children as well. One of the concerns about fluoride is that it can cause fluorosis in children when swallowed during teeth formation. This does not happen with HAP toothpaste due to its biocompatibility.
Specialty/Discipline (Public Health) (General Dentistry) (Restorative Dentistry)
Keywords Hydroxyapatite, toothpaste, fluoride, prevention, caries
ID# 3471
Date of submission: 11/22/2021spacer
E-mail phillipst5@livemail.uthscsa.edu
Author Thais Phillips, DDS
Co-author(s) Zak James, DMD
Co-author(s) e-mail jamesz@livemail.uthscsa.edu
Faculty mentor/Co-author Bennett T. Amaechi, BDS, MSc, PhD
Faculty mentor/Co-author e-mail amaechi@uthscsa.edu
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