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Effectiveness and Cost-effectiveness of Silver Diamine Fluoride (SDF) in Arresting Dental Caries in Primary School aged Children

Effectiveness and Cost-effectiveness of Silver Diamine Fluoride (SDF) in Arresting Dental Caries in Primary School aged Children

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240205060915N1
Enrollment
700
Registered
2024-02-11
Start date
2024-02-28
Completion date
Unknown
Last updated
2024-03-06

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

Conditions

To investigate SDF in arresting active coronal caries lesions on primary teeth and permanent first molars.

Interventions

Intervention 1: Intervention group: Annual SDF + OHE. Intervention 2: Intervention group: Semi Annual SDF + OHE. Intervention 3: Control group: OHE only.

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 8 Years

Inclusion criteria

Inclusion criteria: o All 6-year-olds, grade 1 primary school students who have ECC. o Cooperative children who are willing to participate in oral health education sessions and voluntarily allow oral examination (all groups) and application of SDF (intervention groups) by the examiners at baseline and follow up cessions. o Submission of written consent form by parent/Legal Guardians for participation of their children prior to study initiation.

Exclusion criteria

Exclusion criteria: o Child with gingivitis (redness, swelling, tenderness, bleeding) or any oral ulceration or stomatitis. Developmental dental abnormalities such as enamel defects. Known allergy/sensitivity to silver or other heavy metal ions. Children with more than one-third of the crown missing, or pulp involved (tooth with pulp exposure, presence of an abscess or a sinus tract, obvious discoloration, and hypermobility. Uncooperative children (after the failure of basic pediatric patient management protocols). Children with special healthcare needs (CYSHCN): children who are at increased risk for chronic physical, developmental, behavioral, or emotional conditions. Any child being sick or absent for any reason. Tooth pain at baseline (based on child’s present history) or 7 days after SDF application. Any tooth with failures after SDF treatment. The failure is defined as the treated tooth receiving a restoration, endodontic treatment, or extraction seven or more days after initial SDF application, except for sedative filling/ protective restorations if they occurred within 10 weeks of initial application (30).

Design outcomes

Primary

MeasureTime frame
Dental caries. Timepoint: Following a visual oral/dental examination, each child's oral health status will be documented. Subsequently, silver diamine fluoride (SDF) will be applied to all carious teeth, with repetition based on the assigned intervention group. Follow-up appointments are scheduled for 6 and 9 months after the initial visit. Method of measurement: SDF assessment by direct observation.

Countries

Iraq

Contacts

Public ContactAmmar Albujeer

Shahid Beheshti University of Medical Sciences

a.albujeer@gmail.com+964 780 907 0517

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026