SDF With or Without Fluoride Varnish for Caries Arrest in Primary Teeth of Young Children

Summary

Tooth decay (dental caries) occurs when acids dissolve tooth structure. If not treated, cavities in primary teeth can progress quickly, leading to caries, infection and early tooth loss. These problems may affect chewing, speech, nutrition, and overall health. In Albania and many other countries, cavities in young children are very common. Standard dental treatments are often difficult in very young or uncooperative children and may require sedation or general anesthesia.

Silver diamine fluoride (SDF) is a liquid medication that can be painted directly onto cavities. SDF stops cavities from worsening by killing bacteria and hardening softened tooth surfaces. The main side effect is dark staining of the treated area. Despite this, SDF is considered safe and effective, especially for children who cannot tolerate conventional treatment. Fluoride varnish (FV) is another preventive treatment applied to all tooth surfaces to strengthen enamel and help prevent new cavities.

The purpose of this study is to compare two approaches for managing tooth decay in young children who have difficulty cooperating for dental care:

* SDF applied to cavities every six months.
* SDF applied every six months, with FV applied to all teeth every three months. A total of 104 children between the ages of 1.5 and 8 years with active cavities in their primary (baby) teeth were enrolled. Children were randomly assigned to one of the two treatment groups.

The children were followed for 24 months. The main outcome measured is whether cavities became arrested, meaning the surface became hard and inactive with no further breakdown. Additional outcomes include whether combining SDF with FV provides added benefit and whether baseline factors such as oral hygiene and diet influence treatment success.

The information from this study may help dentists and parents understand how SDF, with or without FV, can be used as a safe, effective, and child-friendly option to manage cavities in young children.

Conditions

• Dental Caries

Interventions

DRUG

Silver Diamine Fluoride (SDF, 38%) and Sodium Fluoride Varnish (NaF, 5%)

Application of 38% silver diamine fluoride (SDF) to all active carious lesions at baseline and every 6 months (months 0, 6, 12, and 18, 24). In addition, a 5% sodium fluoride varnish (NaF) is applied to all teeth at 3-month intervals (months 3, 9, 15, 21). Applications are performed by a dentist using standard microbrush or applicator techniques, ensuring lesions coverage for SDF and full dentition coverage for NaF varnish. This alternating protocol evaluates whether combining periodic SDF with regular fluoride varnish enhances caries arrest in primary teeth compared to semiannual SDF alone.

DRUG

Silver Diamine Fluoride (SDF, 38%)

Application of 38% silver diamine fluoride (SDF) to all active carious lesions at baseline and every 6 months (months 0, 6, 12, and 18, 24). Applications are performed by a dentist using a microbrush to directly cover the lesion surface until fully saturated. No additional fluoride varnish is provided in this arm. The protocol evaluates the effectiveness of semiannual SDF application alone for arresting active caries in primary teeth of young, uncooperative pediatric patients.

Sponsors & Collaborators

• Beaty Dent

  lead OTHER

Principal Investigators

• Manola Kelmendi, DMD, PhD · Faculty of Dental Medicine, University of Medicine of Tirana, Albania

• Shirli Kelmendi, PhD Cand. · Universidad Cardenal Herrera, UCHCEU, Valencia, Spain

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Months

Max Age

8 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-07

Primary Completion

2024-03-25

Completion

2024-03-25

Countries

• Albania

Study Locations