Scientists find a simple way to stop cavities without drilling | ScienceDaily
Summary
A University of Michigan study has revealed that silver diamine fluoride (SDF), a liquid brushed onto cavities, can effectively stop decay in over half of treated baby teeth without drilling or anesthesia. Approved as a medical device for sensitivity, this low-cost treatment, used for decades internationally, now has strong U.S. clinical trial data supporting its efficacy and safety for caries management, potentially benefiting young children and other hard-to-treat patients despite permanently darkening the treated area.
Key Insights
Silver diamine fluoride (SDF) offers a non-invasive method to halt cavity progression in young children.
Untreated cavities lead to significant health issues for young children, including pain, infection, and the need for surgery under general anesthesia. Silver diamine fluoride (SDF) presents a simpler, low-cost alternative. This liquid is applied directly to the cavity using a small applicator, a process that takes only seconds per tooth. The treatment effectively stops decay without the need for drilling, injections, or sedation, although it does cause the decayed area to permanently darken.
New clinical trial data strengthens the case for FDA approval of SDF as a cavity treatment.
While SDF has been used off-label in the U.S. since 2014 for tooth sensitivity and internationally for decades to treat cavities, robust U.S. clinical trial data was previously lacking. A Phase III study led by the University of Michigan, involving 830 children under age 6, provided this evidence. The study found that SDF stopped decay in over half of affected baby teeth when applied every six months. These findings are crucial for the manufacturer to submit a dental caries drug application to the FDA, which could lead to broader acceptance, insurance coverage, and consistent product quality.
Sections
A Long-Used Treatment Gains Stronger Evidence
SDF is an inexpensive liquid that stops many childhood cavities without drilling or anesthesia.
Researchers have demonstrated that a quick and inexpensive liquid, known as silver diamine fluoride (SDF), can effectively halt many childhood cavities without the need for drilling or anesthesia. This treatment provides a simpler option compared to traditional methods which often involve painful procedures and hospital visits for severe cases.
SDF has a history of use internationally and was approved in the U.S. for sensitivity.
SDF has been utilized successfully in numerous countries for many years. In the United States, dentists have been using it off-label since 2014, following its approval as a medical device specifically for reducing tooth sensitivity. However, large-scale U.S. clinical trials to definitively prove its safety and effectiveness as a cavity treatment were pending.
A University of Michigan-led trial provided critical evidence for FDA approval.
A significant clinical trial, spearheaded by the University of Michigan, has now generated the necessary data to support SDF's approval as a drug for treating tooth decay. This Phase III study involved 830 children under the age of 6 and was conducted across Michigan, New York, and Iowa, recruiting participants through various health and educational programs.
SDF Stopped Decay in Many Baby Teeth
The study found SDF stopped decay in over 38% of affected baby teeth.
The research findings indicated that SDF was effective in stopping tooth decay in more than 38% of the affected baby teeth when the treatment was administered every six months. This demonstrates a significant impact on arresting the progression of decay in primary dentition.
SDF is a non-invasive alternative to traditional cavity treatments like fillings.
In contrast to traditional cavity treatments, which typically involve removing decayed tooth material and placing a filling, SDF requires no such removal. The liquid is simply painted directly onto the decayed area, making it a less invasive procedure.
SDF is safe and effective even for very young children.
Margherita Fontana, a professor of dentistry at the University of Michigan School of Dentistry and the study's lead investigator, stated that SDF is a very effective and safe treatment, suitable even for children as young as one year old. This highlights its applicability in early childhood dental care.
Tooth decay is the most common chronic disease in U.S. children.
The article points out that tooth decay is the most prevalent chronic disease among children in the United States, affecting over 40% of this population. Untreated cavities can result in severe consequences, including intense pain, infections, disruptions to sleep and eating patterns, missed school days, and frequent medical consultations.
A Potential Option for Hard-to-Treat Patients
SDF is beneficial for specific patient groups with dental challenges.
Fontana highlighted that SDF could be particularly advantageous for several groups of patients. These include very young children, elderly individuals, people with developmental or physical disabilities, and those who experience severe dental anxiety. It also serves as an option for individuals with limited access to conventional dental care or those who find standard dental procedures difficult to tolerate.
The main drawback of SDF is that it permanently darkens the treated tooth area.
A notable disadvantage of the SDF treatment is that it permanently discolors the decayed portion of the tooth, turning it dark. While this is a cosmetic issue, it is important for patients and caregivers to be aware of this permanent change.
Rigorous evidence supports wider acceptance and implementation of SDF.
Fontana emphasized the importance of rigorous evidence demonstrating both the effectiveness and safety of SDF to enable broader adoption of the treatment. From a public health standpoint, having data from U.S. populations is essential for wider implementation, including in medical settings, allowing more cavities to be treated effectively.
Research continued despite COVID-19 disruptions.
The research initiative commenced in 2018 and persevered through various challenges, including disruptions caused by the COVID-19 pandemic, demonstrating a commitment to obtaining these crucial clinical findings.
Data supports SDF's use in medical settings before dental referrals.
Fontana explained that clinicians require high-quality evidence before altering their practices. Having reliable data is crucial because young children often interact with pediatricians long before seeing a dentist. Broader acceptance of SDF could significantly increase the number of cavities treated in medical settings, potentially preventing them from becoming painful, infected, or requiring surgery.
Findings Could Support FDA Approval
The trial generated evidence needed for an FDA drug application for SDF.
The clinical trial yielded the necessary evidence for the manufacturer, Elevate Oral Care (which supplied the tested product, Advantage Arrest 38% SDF), to submit a dental caries drug application to the Food and Drug Administration (FDA). The National Institute of Dental and Craniofacial Research provided substantial funding, over $12 million, for the study.
FDA approval could expand treatment access and insurance coverage.
Amr Moursi, a professor of pediatric dentistry at New York University College of Dentistry and a co-principal investigator, believes the study's findings could significantly enhance access to SDF. He anticipates that FDA approval, moving SDF beyond its off-label status, would encourage greater utilization by dental providers, improve insurance reimbursements, and ensure more consistent product quality.
SDF can serve as a temporary or long-term solution for decay.
For some children, repeated SDF applications every few months might be sufficient to manage a cavity until the baby tooth naturally falls out. In adults, SDF can act as a long-term treatment option or provide temporary protection until more permanent restorative procedures are affordable or feasible.
SDF can arrest decay, stop infection, and alleviate pain.
Fontana concluded that SDF possesses the capability to arrest decay, effectively stop the infection associated with cavities, and relieve the pain they cause for nearly all individuals. This broad applicability suggests it could be a beneficial treatment for a wide range of people experiencing dental caries.
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Scientists find a simple way to stop cavities without drilling | ScienceDaily
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