Silver Diamine Fluoride for Tooth Decay

Not yet recruiting at 2 trial locations

Overseen By Nadia Gargouri, Assistant professor

Age: 65+

Sex: Any

Trial Phase: Phase 4

Sponsor: Université de Montréal

Disqualifiers: Inadequate collaboration, Cardiac valve issues, Allergies, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Silver Diamine Fluoride (SDF) to determine its effectiveness in stopping tooth decay in elderly individuals living in long-term care facilities. The study compares SDF to a placebo (a treatment that resembles the real thing but isn’t) to assess its effectiveness in managing cavities and improving oral health. Suitable candidates for this trial are those aged 65 or older in long-term care, with at least one untreated cavity that does not involve the tooth's nerve (pulp). The aim is to find a helpful treatment for older adults who struggle to maintain oral hygiene due to reduced mobility. As a Phase 4 trial, this research examines how an already FDA-approved and effective treatment can further benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What is the safety track record for Silver Diamine Fluoride 38%?

Research has shown that silver diamine fluoride (SDF) 38% effectively and safely stops cavities. Studies have found that SDF works as well as traditional methods like sealants used in school programs. It is approved for dental use and is known to be safe.

The most common side effect is black staining on the treated cavities. This staining is permanent but usually only affects the treated area. Other side effects are rare. Overall, SDF is considered safe for preventing tooth decay. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Silver diamine fluoride is unique because it combines silver, which has antimicrobial properties, with fluoride, a mineral known to strengthen tooth enamel. Unlike traditional treatments for tooth decay, like fillings or fluoride varnishes, silver diamine fluoride can stop decay and prevent further progression without the need for drilling or invasive procedures. Researchers are excited about this treatment because it offers a quick and painless way to manage cavities, especially for people who have difficulty accessing traditional dental care. Its ability to not only halt decay but also protect against future cavities sets it apart from other options.

What evidence suggests that Silver Diamine Fluoride is effective for tooth decay?

Studies have shown that 38% Silver Diamine Fluoride (SDF), which participants in this trial may receive, effectively stops cavities from worsening. Research indicates that SDF works as well as traditional dental sealants in preventing tooth decay and is particularly effective in stopping cavities in baby teeth. One study found that a single application of SDF controls cavities effectively compared to standard dental treatments. These findings support using SDF as a reliable option for managing tooth decay, especially for those who might have difficulty with regular dental care. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for elderly individuals living in long-term care facilities who have lost some autonomy and are experiencing tooth decay. They must be able to participate in a study lasting 12 months with several check-ins.

Inclusion Criteria

I am 65 or older and live in a long-term care facility.

I have an untreated, painless cavity or a cavity under a filling without nerve damage.

Exclusion Criteria

Participants with inadequate collaboration that may impede dental examination or treatment

Participants allergic to silver, fluoride or ammonia

I have a heart valve prosthesis, a history of bacterial endocarditis, or valve disease after a heart transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Treatment

SDF group participants receive an SDF application on their active caries; control group receives a placebo application

1 day

1 visit (in-person)

First Data Collection

6 months after baseline, both groups receive SDF application

1 day

1 visit (in-person)

Second Data Collection

12 months after baseline, control group receives SDF application for ethical reasons

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including fluoride varnish application and satisfaction questionnaire

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo solution
• Silver diamine Fluoride 38%

Trial Overview The study tests the effectiveness of Silver Diamine Fluoride (SDF) 38% on stopping active tooth decay compared to a placebo solution. Participants will receive SDF applications at different times over a year, with data collection phases at 6 and 12 months.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

This arm will be provided with the intervention

Group II: Control Placebo Group 1 Intervention

For ethical reasons the control arm will receive treatment after the first phase of data analysis

Who Is Running the Clinical Trial?

Université de Montréal

Lead Sponsor

Trials

223

Recruited

104,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0020653925000061

A Clinical Trial of 38% Silver Diamine Fluoride With Light ... A number of studies have shown the effectiveness of 38% SDF in arresting or slowing caries progression in primary teeth. ... Further, it is now known that the ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2801193

Effect of Silver Diamine Fluoride on Caries Arrest and ... This study found that silver diamine fluoride was noninferior to traditional sealants when used in a school-based program.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05084001

Silver Diamine Fluoride in Preventing Occlusal Caries ... The primary outcome is whether cavitated dentine caries lesion is found in the treated occlusal tooth surface. The null hypothesis tested is that there is no ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jphd.12578

Effectiveness of silver diamine fluoride in arresting dental ... Our results suggest that a single application of 38% SDF solution is an effective measure for arresting and controlling caries compared to standard oral ...

5. aapd.org aapd.org/globalassets/media/events/gao-et-al-2016-clinical-trials-of-silver-diamine-fluoride-in-arresting-caries-among-children-a-systematic-review.pdf

Clinical Trials of Silver Diamine Fluoride in Arresting ... SDF was commonly used at 38%. It was effective in arresting dentine caries in primary teeth among children. Knowledge Transfer Statement: This systematic review ...

6. ada.org ada.org/resources/ada-library/oral-health-topics/silver-diamine-fluoride

Silver Diamine Fluoride One common adverse effect of SDF treatment is permanent black staining of the arrested caries lesions. Biannual applications of SDF are ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0300571217302129

Topical silver diamine fluoride for dental caries arrest in ... Topical 38% silver diamine fluoride is effective and safe in arresting cavities in preschool children. Clinical Significance: The treatment is applicable to ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07153328?term=NA

SDF With or Without Fluoride Varnish for Caries Arrest in ... Safety and Monitoring SDF and fluoride varnish are approved topical agents for dental use and have well-established safety profiles. Adverse events were ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6500430/

Evidence-Based Dentistry Update on Silver Diamine Fluoride Each milliliter of product contains 380 mg (38 w/v%) of Ag(NH3)2F. They described its effects for prevention and arrest of dental caries in children, prevention ...