Cavity Treatment for Children Without Drills or Injections: The Potential of SDF Revealed in a Trial with 830 Participants

Cavity Treatment for Children Without Drills or Injections: The Potential of SDF Revealed in a Trial with 830 Participants

Treatment to Stop Cavities in Baby Teeth Without Using a Drill

Treating cavities in young children presents challenges different from those in adults.

Young children often can't sit still in a dentist's chair, are afraid of the sound and vibration of dental tools, can't keep their mouths open for long, and can't tolerate local anesthesia injections. When cavities spread to multiple teeth, treatment involving sedation or general anesthesia might be considered.

Cavities can't be left untreated. However, parents feel anxious about subjecting their young children to treatments that impose a significant burden.

A method gaining attention to bridge this gap is Silver Diamine Fluoride, abbreviated as "SDF." In Japan, it's known as "Fluoride Diamine Silver" and has been recognized for its use in inhibiting cavity progression.

By applying the liquid to the cavity, the activity of the lesion is suppressed without drilling the tooth. While it doesn't restore the lost shape of the tooth like fillings, it is expected to slow down or stop the progression of cavities.

A large-scale clinical trial published in the medical journal "JAMA Pediatrics" in July 2026 became one of the largest studies in the U.S. to verify the effectiveness of SDF for young children.


Phase III Trial Involving 830 Children Aged 1 to 6

The study included 830 children aged 12 to 71 months, all with severe early childhood caries, including cavities with holes reaching the dentin.

Participants were randomly divided into two groups: 414 children received 38% SDF, and 416 children received a placebo resembling the color.

The medication was applied twice, at the start of the study and six months later. The procedure involved cleaning and drying the cavity area with a toothbrush or small brush, then applying the solution with a special tool for about 10 seconds, without drilling the cavity.

Examinations were conducted at the start, and at 3, 6, and 8 months. Researchers checked whether the cavity area remained soft or had hardened and stopped progressing.

Importantly, the primary evaluation unit for effectiveness was not "the number of children" but "each individual cavity lesion." It doesn't mean that half of the treated children were completely free from cavities.


Arrest Rate at 6 Months Was 54.0%

The results showed a clear progression-inhibiting effect of SDF.

Among the cavity lesions treated with SDF, the arrest rate was 57.5% at 3 months, 54.0% at 6 months, and 50.2% at 8 months.

In contrast, the placebo group's arrest rates were 18.8% at 3 months, 22.5% at 6 months, and 17.4% at 8 months.

At the primary evaluation point of 6 months, the arrest rate in the SDF group was more than double that of the placebo group. The study initially planned to enroll more participants, but new registrations were terminated early at 830 due to confirmed effectiveness in an interim analysis.

If cavity progression can be suppressed for a certain period, options arise such as waiting until the child is old enough to accept dental treatment, planning less burdensome procedures, or avoiding or delaying treatments requiring general anesthesia.

However, at 8 months, about half of the lesions had not been arrested even with SDF. High effectiveness does not equate to stopping all cavities.


Why Cavities Stop with "Just Applying"

SDF is a liquid containing silver, fluoride, ammonia, and other components.

Silver has an antibacterial effect, and fluoride strengthens tooth structure and promotes remineralization. Together, they are believed to suppress the activity of bacteria related to cavities and the breakdown of tooth structure, hardening the softened cavity areas.

In typical filling treatments, the decayed part is drilled out, and the lost shape is restored with materials like resin or metal. SDF is a "non-restorative treatment" that suppresses cavity activity rather than restoring tooth shape.

Therefore, in cases where there are large holes that trap food, possible infection to the tooth nerve, swelling, pus, or persistent severe pain, SDF alone may not suffice.

In this trial, teeth with confirmed pain, infection, or pulp exposure were excluded from the study and referred for necessary treatment. SDF is a medication used based on a dentist's diagnosis and follow-up, differing from typical fluoride products applied at home.


The Biggest Drawback: The Cavity Area Turns Black

SDF has a very noticeable drawback: the cavity area turns dark brown or black, and this color generally remains.

This is due to the reaction of the silver component with the decayed tissue, and the blackening and hardening of the lesion indicate the treatment is working. However, in visible areas like the front teeth, the aesthetic issue becomes significant.

It may not be noticeable on molars or the back of front teeth, but if cavities are on the surface of the upper front teeth, the black areas may be visible when smiling.

Even though baby teeth will eventually fall out, if applied at 1 or 2 years old, the condition may persist for several years until the teeth are replaced. While it doesn't affect the permanent teeth that come in later, some families worry about the child's photos, reactions from others, and the child's potential concern about appearance.

While primarily the decayed areas turn black, temporary staining can occur if the solution contacts skin or mucous membranes. In the study, staining outside the mouth was reported in 2.4% of the SDF group, and inside the mouth in 1.2%.

The American Dental Association also lists the permanent blackening of arrested cavity lesions as a representative side effect of SDF. It's important to review actual photos and understand the aesthetic changes before consenting to treatment.


No Significant Difference in Safety Compared to Placebo

During the trial, the proportion of children reporting any adverse events was 47.3% in the SDF group and 43.3% in the placebo group.

Although the numbers may seem high, they include events not directly related to the trial drug, such as fever, cough, ear infections, constipation, diarrhea, and dental trauma.

Adverse events judged to be related to the treatment were 22.9% in the SDF group and 22.2% in the placebo group, almost the same. Study discontinuation due to adverse events was 7.5% in both groups.

Researchers reported no significant ongoing safety issues after one or two applications. However, there was no clear difference in pain associated with cavities between the SDF and placebo groups.

This means that even if the lesion hardens and progression stops, pain may not necessarily improve. Regular check-ups by a dentist are necessary even after treatment.


Voices on Social Media Highlight "Wanting to Avoid Anesthesia"

A review of public social media posts shows that parents considering SDF are not only concerned about "whether it turns cavities black."

 

Especially for toddlers, it is sometimes explained that sedation or general anesthesia is necessary to fill multiple cavities or place crowns. Parents face anxiety about delaying treatment and worsening cavities, as well as concerns about subjecting young children to anesthesia.

One parent posted about being offered the option to apply SDF to their 16-month-old's front teeth to temporarily suppress cavities until the child is old enough for treatment. Despite reservations about the black areas being visible for over six months, they compared the possibility of future white fillings without sedation.

Another post evaluated the procedure as short, painless, and without sedation, while expressing sadness about the black areas being visible when smiling.

These posts reveal that SDF is not merely seen as "an unsightly treatment," but as a realistic option to avoid anesthesia and invasive procedures.


The Dilemma of "Wanting to Protect a Child's Self-Esteem"

Posts from parents advised to use SDF on front teeth show concerns about the permanent and noticeable black discoloration, with some wondering, "Should I choose to protect the teeth or the child's self-esteem?"

There are worries about the black areas being pointed out by others or children being teased by peers. Especially for toddlers with a long time before permanent teeth come in, it's not easy to dismiss it as "just baby teeth."

Conversely, some have accepted the discoloration to avoid infection or general anesthesia, and found that others pointed it out less than expected.

How much the appearance is perceived as a burden varies depending on the location of the cavity, the child's age, family values, and cultural background. Dental professionals should not just explain that "baby teeth will eventually fall out," but share specific impacts on appearance.


There Are Experiences of "Stopped Cavities," But It's Not a Panacea

Another parent posted that SDF helped stop the progression of multiple cavities in a child with weak tooth formation. However, the family didn't rely solely on SDF, but also practiced nighttime brushing and flossing by parents and used prescribed fluoride toothpaste.

This experience aligns with the conclusions of the current paper. SDF alone doesn't solve everything; it needs to be combined with brushing, fluoride use, dietary habit review, and regular check-ups.

Social media posts are personal experiences and not medical data proving treatment effectiveness. Since the depth and cause of cavities, tooth quality, and lifestyle habits vary for each individual, methods that worked for other families may not apply directly.

Nevertheless, they provide insight into parents' dilemmas, relief, guilt, and feelings about post-treatment appearance that are not easily seen in research paper numbers.


Reasons Not to Overestimate Research Results

This study has several limitations.

First, although 830 people were registered, only 584, or 70% of the total, completed the study. Among those who couldn't be followed up, 81 were due to the impact of the COVID-19 pandemic.

The study period is also limited to 8 months. This trial alone cannot determine whether the effect will be maintained until the baby teeth fall out, how many times it should be applied over a long period, or the optimal interval for reapplication.

Although a second application was made six months after the start, the arrest rate at 8 months was 50.2%, and no additional improvement from the second application was confirmed in this trial. Researchers suggest examining whether shorter intervals for reapplication are effective for children at high risk of cavities.

Moreover, because SDF changes the color of the cavity area, the examiners might have been able to guess which drug was used, possibly compromising the blinding.

Above all, many lesions remained unarrested even with SDF. Researchers themselves concluded that SDF should be combined with other preventive measures and carefully monitored after treatment.


In Japan, It Has Been Used as "Saforide" for a Long Time

This news might make SDF seem like a completely new treatment due to the large-scale U.S. trial, but in Japan, "Saforide Liquid Dental 38%," containing 38% fluoride diamine silver, is registered as a medical pharmaceutical.

The product information lists the inhibition of early cavity progression, suppression of secondary cavities after treatment, and suppression of dentin hypersensitivity as its indications and effects.

Its use is also envisioned for children who are difficult to treat and elderly people who have difficulty visiting the dentist. The blackening of cavity areas is also clearly stated as a product feature.

In the U.S., at the time of the paper's publication, SDF was approved by the FDA for use in hypersensitivity, but its use for stopping cavity progression was off-label. This Phase III trial aimed to obtain data supporting formal approval for stopping cavity progression in children aged 1 to 6.

Therefore, the significance of this study is not that "an unknown new drug was suddenly discovered." It lies in the fact that the effectiveness and safety of a long-used drug were demonstrated in a rigorous comparative trial targeting young children in the U.S.


SDF Adds a "Third Option"

The value of SDF is not in completely eliminating cavities or making drilling treatments unnecessary.

Previously, difficult choices arose for cavities in young children: "immediately drill and fill," "treat all at once with sedation or general anesthesia," or "wait until the child is old enough for treatment."

SDF adds the option of "first suppressing progression and securing time until treatment can be done more safely."

However, to use that time effectively, continuous dental visits are essential. If one stops visiting the dentist after applying SDF, cavities that were not arrested may spread to the nerves or surrounding tissues.

Whether the blackened appearance can be accepted, whether the location and depth of the cavity are suitable for SDF, whether fillings or crowns are needed, and how much treatment with anesthesia can be postponed—these need to be shared with the dentist and individually assessed.

The large-scale U.S. trial showed that SDF is a promising non-invasive treatment for cavities in young children. However, about half of the lesions were not arrested, and pain relief effects were not confirmed.

What is expected is not a "magic potion that cures with a single application," but a realistic means to create time until the next treatment while minimizing the child's physical burden.


Source URL

An article from FinanzNachrichten.de introducing the Phase III clinical trial of SDF conducted in the U.S. for a general audience.
https://www.finanznachrichten.de/nachrichten-2026-08/69215377-silver-diamine-fluoride-treatment-may-stop-tooth-decay-in-children-study-finds-020.htm

Original research paper. Check participants, research methods, cavity lesion arrest rates at each point, safety, and study limitations.
https://jamanetwork.com/journals/jamapediatrics/fullarticle/2851913

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