Dental Caries Clinical Trial
Official title:
ASSESSMENT OF SDF vs. GIC AND HALL TECHNIQUE
Early childhood caries (ECC) ,a global public health problem, highly prevalent and severe with life long implications is entirely preventable. as an alternative to general anesthesia low cost innovative materials such as SDF are promising for low income countries such as Pakistan for reducing the burden of dental caries. SDF may positively transform prevntive and clinical pediatric dental practices and services in Pakistan. FDA approves 38% SDF for arresting caries in vulnerable populations.
Status | Recruiting |
Enrollment | 132 |
Est. completion date | February 2022 |
Est. primary completion date | February 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 10 Years |
Eligibility | Inclusion Criteria: - Patients of both genders. - Age range between 5 to 10 years old. - Both deciduous maxillary and mandibular untreated teeth. - Carious teeth categorized as ICDAS code 4, 5 and 6 will be included. - Active carious lesions on occlusal surface of primary molars Exclusion Criteria: Permanent dentition will be excluded from this study - Primary molar showing signs of irreversible pulpitis - Patients diagnosed with periapical abscess - Patients allergic to silver - Medically compromised or patients with childhood impairment and disability. - Hemophilic patients - Epileptic patients - Non-consenting patients for silver staining |
Country | Name | City | State |
---|---|---|---|
Pakistan | Foundation University Islamabad | Islamabad | Federal |
Lead Sponsor | Collaborator |
---|---|
Foundation University Islamabad |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Caries arresting potential of all 3 treatment groups | At each recall, ICDAS scores were compared to initial values of teeth. Treatment was classified as success when caries on teeth was classified as inactive based on lower ICDAS score compared to initial scores | 6 months | |
Secondary | Parental aesthetic perception questionnaire. | 24 hours | ||
Secondary | Facial Image scale for child anxiety | 24 hours | ||
Secondary | Treatment time through digital timer | 24 hours | ||
Secondary | Gingival irritation from follow-up interview | 24 hours |
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