Caries-preventive effectiveness of adding an antibacterial agent to fluoride varnish among 4-6-year-old children

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2021
INTERVENTION: Intervention1: 1% Chlorhexidine and 5% sodium fluoride varnish application: Two‐step application procedure Child will be comfortably seated on the portable dental chair in upright position. Plaque will be removed from the surfaces of the teeth by wiping with cotton gauze. In the first step, 0.25 mL of the allocated formulation will be dispensed in the dispensing wells. The teeth will be dried using cotton gauze and isolated. The formulation will be applied and allowed to dry up while maintaining complete isolation using suction tips. In the second step, 0.25 mL of 5% NaF varnish will be dispensed in the dispensing wells and will be applied on all the teeth using an applicator tip by using paint on technique. Adequate isolation will be ensured by the use of suction tips throughout the application procedure. After varnish application, the patient will be made to sit with the mouth open for 4 minutes with adequate suction. Thereafter, children will be advised not to rinse or drink anything for half an hour. Parents will be informed to give liquid and semisolid food items on the day of varnish application and avoid tooth brushing at the night. Intervention2: 10% povidone iodine solution followed by 5% sodium fluoride varnish application: Two‐step application procedure Child will be comfortably seated on the portable dental chair in upright position. Plaque will be removed from the surfaces of the teeth by wiping with cotton gauze. In the first step, 0.25 mL of the allocated formulation will be dispensed in the dispensing wells. The teeth will be dried using cotton gauze and isolated. The formulation will be applied and allowed to dry up while maintaining complete isolation using suction tips. In the second step, 0.25 mL of 5% NaF varnish will be dispensed in CONDITION: PRIMARY OUTCOME: Caries incrementTimepoint: Baseline, 3 months, 6 months, 1 year and 2 years SECONDARY OUTCOME: Nutritional statusTimepoint: Baseline, 3 months, 6 months, 1 year and 2 years oral microflora including Mutans streptococci and other salivary parametersTimepoint: Baseline, 1 year and 2 years. Tooth remineralization and gingival bleeding scoresTimepoint: Baseline, 3 months, 6 months, 1 year and 2 years INCLUSION CRITERIA: â?¢ Children aged 4‐6 years of age in government schools of Chandigarh UT â?¢ Children whose parent/guardian gives informed consent
Epistemonikos ID: e7e50c04303c3c93c4f06d66024351a637e1d4f3
First added on: Jul 31, 2024