Dental Caries in Children
Conditions
Brief summary
This study will be conducted to test the cariostatic effect of Nano Silver Fluoride in a comparison to Silver Diamine Fluoride in a group of preschool children.
Detailed description
Silver Diamine Fluoride has offered a non-invasive and easily performed method to manage dental caries in very young children.Studies shows that SDF has been proven to arrest caries in cavitated lesions and to prevent caries in sound teeth as Fluoride is effective in enhancing the remineralization of dental hard tissue and silver ion acts as an antibacterial agent. However, It was found that silver causes staining to the dental tissues with a black discoloration, which can be considered to be a main drawback specifically, when it is used on anterior teeth. Nano-silver fluoride varnish preparation showed high efficacy in arresting caries progression in primary teeth without causing black discoloration to the tissues.Silver diamine fluoride (SDF) . Benefits for patient: 1. Non-invasive treatment leading to reduce patient anxiety and stress. 2. No drilling and filling. 3. Protects against further caries progression. Benefits for the practitioner: 1. Provide alternative treatment options. 2. Pain-free procedure that facilitates child management and saves time. Benefits for the community: 1. Increasing overall oral health 2. Provides more information by testing new material 3. To provide better service quality.
Interventions
NSF is a varnish which has been introduced as experimental formulation . the laboratory synthesis of NSF was carried out in a nano techonolgy center .
DRUGSilver diamine fluoride
38% silver diamine fluoride
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double blinded study. Participants were blinded towards agents used in the study by using two identical squeezable plastic droppers with tag codes A and B. Also the bio-statistician will be blinded from the meaning of codes.
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged from 3 to 5 years * clinical diagnosis of active dentinal caries in primary teeth * Co-operative participants and free of any systemic diseases
Exclusion criteria
* Children whose parents refuse to sign consent * Primary teeth with pulp involvement, pain, mobility, abscess, sinus, fistula; or discoloration related to tooth non-vitality.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| caries lesion activity and severity assessment using Nyvad criteria | baseline | visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICDAS II | baseline | Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin ) |
Countries
Egypt
Outcome results
None listed