Aims : To assess the clinical effectiveness of Chemomechanical versus Conventional caries removal for alternative restorative treatment (ART). Objectives: To compare the success of the restorations at 1, 6 and 12 months between the groups. To compare the time taken and pain reaction measured by the Sound, Eye, and Motor scale (SEM) between the groups. Justification for study (whether of national significance with rationale) : Chemomechanical caries removal technique provides less anxiety and more clinical acceptance thus instilling a positive attitude towards dental treatment in a person. This study would also provide information regarding the efficacy of newer caries removal techniques that can be used in community or field settings. Departments involved: Department of Public Health Dentistry, Manipal college of Dental Sciences, Manipal. Study period: 18 months Sample size: G-power software, 82 (With the effect size of 0.5, power of 95% and significance level of α=0.05, yielded a sample size of 52. Considering an attrition of 20%, we inflated the sample size to 82.) Materials and methods: a) Inclusion criteria: Children aged 6-15 years, with one or more than one cavitated carious lesions, single surface, occlusal load bearing area, which are be accessible to hand instruments in permanent dentition. Consent given by children and their parents are included. b) Exclusion criteria : Presence or history of pain/abscess/fistula/swelling near to the carious tooth. Deep carious lesions exposing pulp of tooth. Presence of tenderness on percussion. Children with syndromes, undergoing orthodontic treatment, developmental defects of teeth, or any other conditions that contraindicate the caries excavation/restorations. c) Biological materials required (type - blood, tissue etc and quantity): Nil d) Statistical methods: Intergroup comparisons would be done with chi-square test/ Student t-test 9. Detailed description of procedure / processes: School children would be screened based on inclusion and exclusion criteria. Eligible children and their parents would be approached for consent and participation in the study. Children would be randomized into Group I and Group II based on the block randomization. Group 1 will receive Chemomechanical caries removal using Carie care as per manufacturer instructions followed by alternative restorative treatment using Fuji IX restorative material. Group 2 will receive conventional caries removal using excavators followed by alternative restorative treatment using Fuji IX restorative material. evaluated at 1, 6 and 12 months (scores 0, 1 and 7) 11. Potential risks: Children may experience mild discomfort during excavation of caries. Benefits: Treatment of caries at early stages prevents further progression of the disease. 12. Ethical considerations and methods to address issues : Informed consent, indirect identifiers for maintaining confidentiality. Patient may experience pain which might require root canal treatment. Camp cards will be provided to avail the necessary treatment at subsidized rates. 13. Budget : 12,100 |