Anti caries effect of three different varnishes on Milk teeth

Phase 4

Not yet recruiting

Brief Summary: Early Childhood Caries is a major dentaldisease affecting 60%-90% of children worldwide. The traditional way to manageEarly Childhood Caries involves removal of infected part followed by fillingthe cavity to restore the function and aesthetics of the tooth. However, young or apprehensivechildren are not able to cooperate for lengthy and complex restorativeprocedures. When the literature search was carried out in pastthree months, it was seen that there are a few studies carried out comparingthe effectiveness of Sodium Fluoride Varnish and Silver Diamine Fluoride in arrestingearly childhood caries in children. Hence, with this lacunae the present studyis being designed to compare the cariostatic strategy of fluoride varnish, 38% silver diamine fluoridewith 20% potassium iodide solution in primary teeth- a clinical follow-upstudy. This is an in vivo, double-blinded, triple arm, randomized controlled study inchildren. The study will be conducted in different Schools of Belagavi, Karnataka. Participants who will fulfill the inclusion andexclusion criteria shall be selected for the study. Data will beStatistically Analyzed by ANOVA . Groups of sampleswill be assessed clinically using tactile and visual inspection for 1month,3 monthand 6 month follow-up. Follow-up will be done for color of cariouslesion(yellow, brown and black),consistency(hard, medium and soft),arrestedlesions and new active lesions.

Recruitment & Eligibility

Inclusion Criteria

1.Teeth having caries involving enamel and dentin of first and second deciduous molars in age group between 3years-8years of children with dental Caries 2.Children had to have at least 1 carious lesion as defined by the International Caries Detection and Assessment System II (ICDAS II).
Using ICDAS II, Code 3,4 (Non-cavitated lesions) and code 5(cavitated lesion) will be included in the study (Code 3- Localized enamel breakdown without clinical visual signs of dentinal involvement seen when wet and after prolonged drying, Code 4- Underlying dark shadow from dentine ,Code 5-Distinct cavity with visible dentine) 3.Absence of symptoms indicative of pulpal inflammation such as spontaneous pain and history of nocturnal pain 4.No clinical or radiographical evidence of pulp pathology.

Exclusion Criteria

1.Children allergic to silver 2.Non-restorable grossly decayed teeth 3.Primary molars having spontaneous pain, swelling or fistula 4.Mobility of the tooth present 5.Teeth with pathological root resorption namely internal or external root resorption.
6.Developmental defects such as amelogenesis imperfecta or dentinogenesis imperfecta 7.Patients/ parents unwilling to participate in the study.

Primary Outcome Measures

Name	Time	Method
To determine the caries reduction after application of Fluoride Varnish, 38% Silver Diamine Fluoride, 38% Silver Diamine Fluoride with 20% Potassium Iodide Solution on primary teeth	Caries reduction will be assessed after application of Fluoride Varnish, 38% Silver Diamine Fluoride, 38% Silver Diamine Fluoride with 20% Potassium Iodide Solution on primary teeth after baseline,1 month, 3 months and 6 months interval

Secondary Outcome Measures

Name	Time	Method

Locations (1): KAHERS KLE V.K Institute of Dental Sciences, Belagavi
🇮🇳
Belgaum, KARNATAKA, India
KAHERS KLE V.K Institute of Dental Sciences, Belagavi
🇮🇳Belgaum, KARNATAKA, India
Dr Shweta Kajjari
Principal investigator
9964525733
drshwetakajjari@gmail.com