Dental Caries
Conditions
Keywords
Atraumatic Restorative Treatment, Chlorhexidine, Silver Diamine Fluoride, Primary Teeth
Brief summary
The purpose of this study is to evaluate the effectiveness of silver diamine fluoride (SDF) compared to chlorhexidine (CHX) as a cavity disinfectant in primary molars after Atraumatic Restorative Treatment approach (ART).
Detailed description
This study is a three arm randomized controlled clinical trial, where children with an age range of 4-6 years indicated for Atraumatic Restorative Treatment (ART) are selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. Sixty teeth are randomly allocated into 3 groups of Atraumatic restorative treatment approaches. Group I is assigned to silver diamine fluoride as an antibacterial agent, Group II is assigned to chlorhexidine as an antibacterial agent, and Group III serves as a negative control.
Interventions
DRUGSilver Diamine Fluoride
SDF will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect)
DRUGChlorhexidine
Chlorhexidine will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect)
PROCEDUREAtraumatic Restorative Treatment without Disinfection
Atraumatic Restorative Technique will be performed without cavity disinfection
Sponsors
Alexandria University
Nourhan M.Aly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The operator will not be blinded to the type of treatment as each antibacterial agent has different consistency, color and application technique. However the expert assessing the microbiologic sample and statistician will be blinded to the treatment groups.
Intervention model description
This study is a three arm randomized controlled clinical trial, where children indicated for Atraumatic Restorative Treatment (ART) will be selected.
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Children free of any systemic disease or special health care needs. * Class I cavity involving dentin in primary molars. * Lesion wide enough to allow access of instruments. * Informed consent fulfilled.
Exclusion criteria
* Signs of irreversible pulpitis or pulp necrosis. * Patients allergic to silver products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the streptococcus mutans count. | 14 days | A second dentin sample will be taken from the same position with a sterile round bur for bacteriologic assessment. |
| Change in the total viable count. | 14 days | A second dentin sample will be taken from the same position with a sterile round bur for bacteriologic assessment. |
| Change in the lactobacilli count. | 14 days | A second dentin sample will be taken from the same position with a sterile round bur for bacteriologic assessment. |
| Microbiological assessment of total viable bacterial count | First day (baseline) | The first dentin sample will be collected with a sterile spoon excavator from the firm dentin in the center of the cavity. Two microliters of the samples collected will be inoculated on blood agar for total viable count. |
| Microbiological assessment of streptococcus mutans count | First day (baseline) | The first dentin sample will be collected with a sterile spoon excavator from the firm dentin in the center of the cavity. Two µl of the samples will be inoculated on mitis salivarius agar supplemented with 15 percent sucrose and bacitracin (0.2 U/ml) for selective isolation of Streptococcus mutans. |
| Microbiological assessment of lactobacilli count | First day (baseline) | The first dentin sample will be collected with a sterile spoon excavator from the firm dentin in the center of the cavity.Two µl of the samples will be inoculated on Rogosa agar, a medium selective for Lactobacilli. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical changes in the dentin consistency | 14 days | Restoration will be removed and the dentin will be checked using visual-tactile method of examination. |
| Clinical changes in the dentin color | 14 days | Restoration will be removed and the dentin will be checked using visual-tactile method of examination. |
Countries
Egypt
Outcome results
None listed