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

NCT07153328 | Completed

• 1 other identifier: SDF-FV-TRIAL-2021-2022
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Caries arrest rate of treated lesions

  Proportion of active carious lesions that transition to a hardened, non-progressive state (surface hardness on probing, dark discoloration, no cavitation/enlargement), assessed by visual-tactile examination using ICDAS-based criteria under proper lighting and dry conditions. Evaluations conducted by blinded assessors.

  Baseline, 6, 12, 18, and 24 months post-treatment

Secondary Outcomes (1)

• Progression of treated lesions to advanced caries or pulpal complications

  6, 12, 18, and 24 months post-treatment

Study Arms (2)

Semiannual 38% Silver Diamine Fluoride (SDF)

EXPERIMENTAL

Participants assigned to this arm receive topical 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%) and Sodium Fluoride Varnish (NaF, 5%); Drug: Silver Diamine Fluoride (SDF, 38%)

Alternating 38% SDF + 5% Sodium Fluoride Varnish (FV)

ACTIVE COMPARATOR

Participants assigned to this arm receive topical 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.

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

Interventions

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

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.

Also known as: Saforide (Toyo Seiyaku Kasei, Japan), Advantage Arrest (Elevate Oral Care, USA), Riva Star (SDI, Australia), 3M™ Fast Release Varnish, Duraphat (Colgate), CavityShield (3M), Flor-Opal (Ultradent)

Alternating 38% SDF + 5% Sodium Fluoride Varnish (FV); Semiannual 38% Silver Diamine Fluoride (SDF)

Silver Diamine Fluoride (SDF, 38%) DRUG

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.

Also known as: Saforide (Toyo Seiyaku Kasei Co., Japan), Advantage Arrest (Elevate Oral Care, USA), Riva Star (SDI Limited, Australia) 3M™ Fast Release Varnish, Duraphat (Colgate-Palmolive), CavityShield

Semiannual 38% Silver Diamine Fluoride (SDF)

Eligibility Criteria

• Age: 18 Months - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1.5 to 8 years
• Uncooperative to dental procedures (Frankl Behavior Rating 1 or 2)
• Presence of at least one active, cavitated carious lesion in primary teeth, without pulp involvement
• Eligible primary teeth: active caries without pulp involvement

You may not qualify if:

• Children with clinical signs of infection (pain, parulis, fistula, or abscess)
• Cooperative to dental procedures
• Children who are candidates for conscious sedation
• Known allergy to silver, fluoride, or ammonia
• Teeth with pulpal complications, non-restorable, exfoliating, or scheduled for extraction

Sponsors & Collaborators

• Beaty Dent: lead

Study Sites (2)

Beaty Dent

Tirana, Tirana, 1001, Albania

Location

Happy Dent

Tirana, Tirana, 1001, Albania

Location

Related Publications (4)

• Duangthip D, Wong MCM, Chu CH, Lo ECM. Caries arrest by topical fluorides in preschool children: 30-month results. J Dent. 2018 Mar;70:74-79. doi: 10.1016/j.jdent.2017.12.013. Epub 2017 Dec 28.

  PMID: 29289726 BACKGROUND

• Trieu A, Mohamed A, Lynch E. Silver diamine fluoride versus sodium fluoride for arresting dentine caries in children: a systematic review and meta-analysis. Sci Rep. 2019 Feb 14;9(1):2115. doi: 10.1038/s41598-019-38569-9.

  PMID: 30765785 BACKGROUND

• Abdellatif EB, El Kashlan MK, El Tantawi M. Silver diamine fluoride with sodium fluoride varnish versus silver diamine fluoride in arresting early childhood caries: a 6-months follow up of a randomized field trial. BMC Oral Health. 2023 Nov 17;23(1):875. doi: 10.1186/s12903-023-03597-5.

  PMID: 37978488 BACKGROUND

• Chu CH, Lo EC, Lin HC. Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children. J Dent Res. 2002 Nov;81(11):767-70. doi: 10.1177/0810767.

  PMID: 12407092 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

silver diamine fluoride; sodium fluoride topical preparation; Sodium Fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Manola Kelmendi, DMD, PhD

  Faculty of Dental Medicine, University of Medicine of Tirana, Albania

  PRINCIPAL INVESTIGATOR

• Shirli Kelmendi, PhD Cand.

  Universidad Cardenal Herrera, UCHCEU, Valencia, Spain

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: No other parties were masked in this study beyond the outcomes assessor, who was blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Director- Pediatric Dentistry Unit Beaty Dent Clinic

Model Details: Participants were randomized into two parallel groups: (1) semiannual application of 38% silver diamine fluoride (SDF) to active lesions, or (2) an alternating protocol of 38% SDF applied to active lesions and 5% sodium fluoride varnish (FV) applied to all teeth every three months. Participants remained in their assigned group for the 24-month follow-up period.

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: September 3, 2025
• Study Start: January 7, 2021
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AL (2)