Effectiveness and Cost-effectiveness of Silver Diamine Fluoride (SDF) in Arresting Dental Caries in Primary School aged Childre
- Conditions
- To investigate SDF in arresting active coronal caries lesions on primary teeth and permanent first molars.
- Registration Number
- IRCT20240205060915N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 700
oAll 6-year-olds, grade 1 primary school students who have ECC.
oCooperative 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.
oSubmission of written consent form by parent/Legal Guardians for participation of their children prior to study initiation.
oChild 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).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method