Dental Caries
Conditions
Keywords
Silver Diamine Fluoride, 38% SDF, Light Curing, Primary Teeth, Pediatric Dentistry
Brief summary
This randomized clinical trial aims to evaluate and compare the clinical and radiographic performance of 38% silver diamine fluoride (SDF) with 38% silver diamine fluoride followed by light curing in children with carious primary molars. Children aged 4-8 years with active caries in mandibular primary molars will be included in the study. One group will receive 38% silver diamine fluoride followed by LED light curing, while the comparison group will receive 38% silver diamine fluoride without light curing. The primary outcome is postoperative pain, assessed using the visual analogue scale (VAS). Secondary outcomes include caries lesion arrest, lesion extension and severity, signs of infection, pain on percussion, pathological tooth mobility, and radiographic changes. Participants will be followed for 12 months. The findings may help determine whether adding light curing to silver diamine fluoride application improves the management of caries in primary molars.
Interventions
Topical application of 38% silver diamine fluoride to carious lesions in primary molars for 1 minute, followed by gentle air drying for 10 seconds, without light curing.
DEVICELED light curing
LED light curing applied for 20 seconds after topical application of 38% silver diamine fluoride, using a wavelength of 420-480 nm and an intensity of 1200-1500 mW/cm².
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Statistician
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy and cooperative children aged 4-8 years. * Children with active carious lesions in mandibular primary molars, with ICDAS scores of 3-6. * Teeth with normal pulp or reversible pulp inflammation. * Children able to attend the scheduled follow-up visits.
Exclusion criteria
* Teeth with pulpal involvement. * Teeth with abscess or fistula. * Teeth with pathological mobility or non-restorable carious lesions. * Children unable to attend follow-up visits. * Children with general health conditions that make them unsuitable for participation. * Children with a known allergy to silver.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | At baseline and at 3, 6, 9, and 12 months after treatment. | Postoperative pain will be assessed using a visual analogue scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Internal or external root resorption | At baseline, 6 months, and 12 months after treatment. | Presence or absence of internal or external root resorption on radiographic examination. |
| Caries lesion arrest | At baseline and at 3, 6, 9, and 12 months after treatment. | Assessment of whether the carious lesion has arrested (yes/no). |
| Caries lesion severity (ICDAS) | At baseline and at 3, 6, 9, and 12 months after treatment. | Assessment of caries lesion severity using ICDAS scores 3-6. |
| Caries lesion activity (Nyvad criteria) | At baseline and at 3, 6, 9, and 12 months after treatment. | Assessment of lesion activity using Nyvad criteria scores 0-9. |
| Soft-tissue pathology | At baseline and at 3, 6, 9, and 12 months after treatment. | Presence or absence of swelling, sinus tract, or fistula. |
| Pain on percussion | At baseline and at 3, 6, 9, and 12 months after treatment. | Presence or absence of pain on percussion. |
| Pathological tooth mobility | At baseline and at 3, 6, 9, and 12 months after treatment. | Presence or absence of pathological mobility. |
| Widening of the periodontal ligament space | At baseline, 6 months, and 12 months after treatment. | Presence or absence of widening of the periodontal ligament space on radiographic examination. |
| Furcation or periapical radiolucency | At baseline, 6 months, and 12 months after treatment. | Presence or absence of furcation or periapical radiolucency on radiographic examination. |
Contacts
CONTACTTarteel Abdelrahman Alsmani Mohammed Ali, Principal Investigator
Outcome results
None listed