University
Al Mansurah, El Gomhoria Street, Mansoura,egypt, 35511, Egypt
NCT Number: NCT05438381
This study conducted on thirty children aged 3-6 years old of both genders, have bilateral carious lower first primary molars. Pre-operative periapical x- ray were taken for both sides. The children were divided into 2 groups(SMART group and ART group). For Atraumatic Restorative Technique (ART technique), glass ionomer cement(GIC) was applied according to manufacturer's instructions. For Silver Modified Atraumatic Restorative Technique (SMART technique), SDF was applied carefully using bended micro sponge brush. It was applied directly to only the affected tooth surface. After one week GIC was applied according to manufacturer's instructions. Clinical and radiographic evaluation were done for all teeth at 6, 12 months. The data were collected then statistically analyzed using chi-square test to show the difference between groups.
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Al Mansurah, El Gomhoria Street, Mansoura,egypt, 35511, Egypt
Sample size calculation:
For this study, a sample size of 30 was obtained using unpaired two sample two tail z-test. The effect size (dz=2.813) and the required sample size were calculated for α =0.05 and a confidence power of 0.8039, assuming a normal distribution.
Patient selection: This study conducted on thirty children aged 3-6 years old of both genders. The children selected from Pediatric Dental Clinic, Faculty of Dentistry, Mansoura University. Included children in the study were. Apparent healthy and free from any systemic diseases or chronic conditions. Child should have bilateral restorable carious lower first primary molars, occlusal caries, International Caries Detection and Assessment System(ICDAS) score (4, 5), asymptomatic or have reversible pulpitis. Radiographic examination show intact lamina dura, absence of internal and external pathological root resorption or periapical infection.
Randomization. The study was spilt mouth design. The right side of all participants was done atraumatic restorative technique (ART) and the left side was silver modified atraumatic restorative technique (SMART technique).
Clinical procedures:
Experimental group: Left side of the patient (SMART technique) (group 2) (D2):(21)
Evaluation:
All primary molars were evaluated clinically and radiographically at 6 and 12 months for the overall success/failure criteria:
Statistical Analysis:
The collected data were tabulated and statistically analyzed . The results were considered statistically significant at p≤0.05.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
Glass ionomer capsule (GC, USA)
silver diamine fluoride (SDF) then glass ionomer cement capsule (GC, USA)
Time frame: 12 months
numerical/visual analogue scale 0 no pain 10 worst possible pain
Time frame: 12 months
x ray will be done( qualitative assessment looking for presence of interradicular or periapical radiolucency will be performed and will be scored as yes or no)
Time frame: 12 months
x ray will be done( qualitative assessment looking for presence of pathological internal or external root resorption will be performed and will be scored as yes or no)
Time frame: 12 months
clinical method of assessing tooth mobility 0 no mobility 3 mobility more than 2 mm bucco-lingually
Time frame: 12 months
visual inspection( visual assessment will be performed clinically looking for presence or absence and will be scored yes or no)
Mansoura University
Other
Assistant Lecturer of Pediatric Dentistry, Mansoura University (2019)
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