Skip to content

Effectiveness of Silver Diamine Fluoride (SDF) in Combination with Fluoride Varnish in Arresting Dental Caries

Comparison of the Clinical Effectiveness of 38% Silver Diamine Fluoride (SDF) Alone and in Combination with Fluoride Varnish in Arresting Dental Caries in Children Under 7 Years Old

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20260422069128N2
Enrollment
238
Registered
2026-05-05
Start date
2026-05-10
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The effect of SDF in arresting active caries lesions on primary teeth and permanent first molars, with or without varrnish fluoride.

Interventions

Intervention 1: Intervention group: An initial examination is performed on the patient on a fixed or mobile unit chair in the appropriate position using appropriate lighting, using a mirror and a prob

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 7 Years

Inclusion criteria

Inclusion criteria: Children aged between 1 and 7 years. Children presenting with at least one carious lesion classified with ICDAS codes 3, 4, or 5. Children who are currently unwilling to undergo definitive restorative treatment for any reason.

Exclusion criteria

Exclusion criteria: Dental caries with spontaneous pain or infection. Potential participants unable to adhere to the follow-up schedule. Children who have a known allergy to fluoride. Children who are completely uncooperative.

Design outcomes

Primary

MeasureTime frame
Caries status in terms of whether it has arrested or not. Timepoint: Baseline, 6 weeks after intervention, 6 months later if possible. Method of measurement: The lesion will be assessed by visual inspection and palpation using a probe and mirror. At baseline, lesions with code 3 will be recorded as active if their surface is white or dull yellow and lacks luster; or feels rough to the touch with a probe. All lesions with code 4 will be recorded as active. After 6 weeks, lesions with codes 3 or 4 will be considered arrested if they have not progressed to cavities and have not changed to codes 5 or 6. Arrested caries is shiny black and hard on examination with a probe. Lesions that were pitted at the start of the study (ICDAS code 5) will be recorded as active if they feel soft to the touch. After 6 weeks, if the wall or floor of the lesion is soft and easily penetrated with gentle pressure of the probe, it will be diagnosed as an active lesion. A lesion whose entire surface is hard and smooth will be diagnosed as arrested.

Secondary

MeasureTime frame
Acceptance of silver diamine fluoride. Timepoint: Initially when obtaining consent and at follow-up after 6 weeks. Method of measurement: The acceptance of silver diamine fluoride to parents will be assessed by completing two questionnaires at the initial consent stage and at the 6-week follow-up. Responses to the questions will be in Likert and multiple-choice format. Parents will be asked whether they are satisfied with the appearance of their child's teeth and responses will be recorded in Likert format. Parents will be asked about side effects of silver diamine fluoride, including tooth or gum pain, gum swelling, gum discoloration, and systemic effects such as nausea, vomiting, or general discomfort.This questionnaire is a translation of questions used in previous studies, and according to the opinions of experts and professors of Tabriz Dental School, three more questions have been added to it. Before conducting the study, questions with Likert options will be provided to ten relevant experts and specialists to calculate CVI and CVR to measure the content validity of the questionnaire. To measure the reliability of the questionnaire questions, about 20 parents will complete this questionnaire twice in the pilot phase, one week apart, and Cronbach's alpha and intraclass correlation will be calculated.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasrin Sharififard

Tabriz University of Medical Sciences

nsharifid@yahoo.com+98 41 3334 0310

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026