Summary Background: Dental caries is a global public health challenge. The objective of this 18-month, double-blind, randomized clinical trial was to compare the cavity prevention effect of a fluoride-free toothpaste with hydroxyapatite (test) and a sodium fluoride toothpaste (1450 ppm fluoride). ; positive control) in adults. . Methods: The primary endpoint was the percentage of subjects who did not show an increase in the overall deteriorated missing filled surfaces (DMFS) index. The study was designed as a non-inferiority trial. Non-inferiority was claimed if the upper limit of the exact one-sided 95% confidence interval for the difference in the primary endpoint DMFS between the test and control toothpaste was less than the predefined margin of non-inferiority (Δ ≤ twenty %). Results: In total, 189 adults were included in the intention-to-treat (ITT) analysis; 171 subjects completed the per protocol (PP) study. According to PP analysis, no increase in DMFS index was observed in 89.3% of subjects in the hydroxyapatite group and in 87.4% of subjects in the fluoride group. Hydroxyapatite toothpaste was not statistically inferior to a fluoride toothpaste with respect to the primary endpoint. Conclusion: Hydroxyapatite was shown to be a safe and effective anti-caries agent in oral care. The results of this randomized, double-blind, long-term clinical trial in adults clearly show the non-inferiority of fluoride-free hydroxyapatite toothpaste versus 1450 ppm fluoride toothpaste with respect to the primary endpoint of the DMFS index. According to per-protocol analysis, no increase in DMFS index was observed in 89.3% of subjects in the hydroxyapatite group and in 87.4% of subjects in the fluoride group. In conclusion, hydroxyapatite was shown to be a safe and effective anti-caries agent in oral care. Clinical trial registration: NCT04756557. |
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Patients who used a toothpaste containing a mineral crucial for bone formation were no more likely to develop cavities than patients who used a toothpaste with fluoride.
Can we improve the toothpaste we use to keep our teeth clean, avoiding medical problems that arise from poor dental health? Most toothpastes use fluoride , a powerful oral hygiene tool. However, fluoride can pose health problems in some cases, especially for children who consume too much fluoride by swallowing most of their toothpaste: children typically use only a small dose of toothpaste to avoid these problems, but that reduces the effectiveness of tooth brushing. In search of alternatives, a team of international scientists and Polish doctors have identified a toothpaste with hydroxyapatite that works as well as toothpaste with fluoride in protecting against cavities.
“Hydroxyapatite is a safe and effective alternative to fluoride in cavity prevention for daily use,” said Professor Elzbieta Paszynska of the Poznan University of Medical Sciences, co-principal investigator and corresponding author of the study published in Frontiers in PublicHealth .
Minimally invasive dentistry
Hydroxyapatite is a calcium phosphate mineral found in the skeleton . It is known to be very safe for human consumption and has previously been shown to help with oral conditions such as periodontitis. It can inhibit tooth demineralization, a key step toward cavities, and contribute to remineralization, which strengthens damaged tooth surfaces.
“In dental care today, the goal is to use ’minimally invasive dentistry’ as often as possible,” Paszynska explained. “This means trying to preserve as much dental tissue as possible, including those altered by initial decay that still show the ability to remineralize. "The use of remineralization compounds is a blessing as it can limit the need for invasive treatment of carious lesions with a drill."
To see if it would help patients without specific dental conditions, doctors recruited 189 adults ages 18 to 45 to participate in an 18-month, double-blind, randomized clinical trial. Their goal was to see all patients through the end of the study without an increase in cavities.
171 patients completed the trial, split evenly between the hydroxyapatite toothpaste group and the fluoride toothpaste control group. All patients had at least 10 cavity-free teeth, were willing to use an electric toothbrush, and had no preexisting dental problems that needed treatment. Patients were provided with electric toothbrushes and replacement heads for these brushes, as well as neutrally packaged toothpaste that may have contained hydroxyapatite toothpaste or fluoride toothpaste. Neither patients nor examiners knew which toothpaste a given patient was using, and patients did not use other oral care products. They were also asked to brush their teeth at the same time every day, twice a day, after meals, for three minutes each time, but they were not asked to change their diet.
“We did not monitor each subject’s diet since the goal was to test two different toothpastes, not the influence of diet on caries progression,” Paszynska said.
Equally effective hydroxyapatite
Throughout the trial, patients visited doctors every six months for an exam and to receive a new supply of toothpaste. Their teeth were visually examined and checked for shadows that could reveal early-stage decay using a DIAGNOcam device. A plaque revealing solution was also used to see how clean their teeth were. Each stage of the trial was monitored for consistency between patients, and patient safety was monitored at each appointment to ensure there were no unforeseen side effects.
At the end of the trial, scientists found that almost 90% of patients in both groups had no new cavities . There was no statistical difference in effectiveness between patients who used a toothpaste with hydroxyapatite and the control group who used a toothpaste with fluoride: both worked equally well.
“Previously published clinical trials also show the caries-preventive effect of hydroxyapatite in risk groups such as children and patients receiving orthodontic therapy,” Paszynska said. “With our new clinical trial, hydroxyapatite has been shown to prevent tooth decay in adults. “This is important from a public health perspective.”
