To check the effiency of Silver Diamine Fluoride And Sodium Fluoride Varnish In Preventing New Carious Lesion In Pre-Schoolers
- Conditions
- the study will be conducted On non-carious healthy teeth
- Registration Number
- CTRI/2019/06/019557
- Lead Sponsor
- Hasti Charitable Trust
- Brief Summary
**METHODOLOGY**
The 3-6 years old children from Hasti Public School, Dondaicha, Dist- Dhule will be selected. Parents of each student will be contacted personally when the screening will be conducted. All information related to the study will be delivered to them. These children will be screened under natural light using sterilized diagnostic instruments and the subjects will be selected as per the inclusion and exclusion criteria. A clinical examination of the participating children will be performed primarily through a careful visual inspection with the aid of a WHO Periodontal probe.
After examination only non-cavitated healthy primary dentition having low risk caries where dmfs score and ICDAS II score will be zero. According to Clinical finding mentioned in CAT tool given by AAPD in their guidelines, states that low risk children are those having non- cavitated carious lesion. Total population for presenting study would be 284 students. It will be selected as per the inclusion criteria and will be randomly divided in three groups. The examined teeth will be randomly allocated in three groups by co-investigator with chit method. The 94 students will be randomly ordered and sequentially assigned for application of Silver diamine fluoride, 94 for application of fluoride varnish and rest 94 students for placebo i.e non-ionized distilled water which will act as control.
Randomization-
1. Sample allocation – age matched samples will be randomly selected from the population by lottery method.
2. Blinding – The study is triple blinded.
Randomization will carried out by co-investigator 1 (AD), Co-investigator 2 (YS) will perform application of SDF, Sodium fluoride varnish and Non-ionized distilled water on the participants and Principal investigator will be blinded and record the indices. Similarly, all the data will be coded and then will be sent to statistician for data anlaysis. Dispensing containers of the agent will be sealed hence, the participants will not be knowing which material is being used in him/her.
First the demographic details will be collected and entered in the proforma. Examination will be carried out in natural day light with children seated upright in chair with back rest. Autoclaved diagnostic instruments will be used for recording the indices. Principal investigator will do all the oral examination and index recording. For data recording purpose an assistant will be trained who will help the Principal investigator during data recording. Photograph of clinical intraoral examination and index recording procedure in school will be taken for record purpose. Co-investigator/ Guide (AD) will be supervising the research and visit during the research intervention. Permission to take leaves from academic routine for conduct the study is been taken.
**METHOD OF EXAMINATION**
Visual examination will be done by Magnifying loupes 2x and LED light. Data will be recorded using loupes before application.
**METHOD OF APPLICATION**
The method of application will be done by principal investigator only after group allocation. The non-cavitated teeth will be randomly divided into 3 groups:
Group A- Control group (PLACEBO) (94 subjects)
Group B – Fluoride Varnish group (94 subjects)
Group C – SDF group (94 subjects)
GROUP A [Control group (PLACEBO)]: Tooth surface will be dried before application of Non-Ionized Distilled water. Entire procedure will be carried out with cotton roll isolation.
GROUP B [Sodium Fluoride Varnish group]: Tooth surface will be dried before application of Sodium Fluoride varnish. The isolation will be maintained throughout the procedure with cotton rolls. Then, thin layer of Voco Proflouride varnish using a suitable single-use applicator will be applied. Now, Cotton rolls will be removed after 1 minute and patient will be asked not to rinse the mouth for 45 minutes. Patients will be advised neither to eat nor brush their teeth for next 45 minutes.
GROUP C [SDF GROUP]: Teeth will be isolated and kept dry with cotton rolls. One drop of SDF will be dispensed on a plastic dappen dish, applicator tip will be used to apply the SDF on tooth surfaces of primary teeth for 2 min. The excess will be removed by gentle blotting with another cotton pellet. After treatment, the children will be asked not to eat or drink for 1 hr.
Each group will be subjected to 3 applications of these interventions at 6 months intervals. Every 6 months interval, evaluation of the incidence of caries will be conducted considering clinical appearance under natural light. All children will be evaluated for incidence of caries after every 6 months’ interval.
**METHOD OF EVALUATION**
For data recording two indices would be used namely dmfs and ICDAS 2 (ANNEXURE 2) will be used.
**Costs calculations:**
The costs of providing the preventive intervention, the costs of all treatment for newly formed carious lesions in relation to caries experience will be assessed. The costs of preventing caries will be estimated using Number of participants, number of product bottles/tubes used and also cost of product. Mean range costs will be presented for each treatment category in preventing caries. As the number of visit is same the travel cost, equipment and armamentarium used will be same in all the three groups.
Cost per child = No. of bottle \* Cost of bottles or tube/No. Of participants
Cost effectiveness will be calculated of each group using this formula:
Cost effectiveness = Total number of new carious lesion/No. Of participants
OBJECTIVES
1. To evaluate the effectiveness of sodium fluoride varnish on caries status with dmfs (Decayed Missing Filled Surfaces) and ICDAS 2 (The International Caries Detection and Assessment System) indices.
2. To evaluate the effectiveness of Silver Diamine fluoride caries status with dmfs (Decayed Missing Filled Surfaces) and ICDAS 2 (The International Caries Detection and Assessment System) indices.
3. To evaluate the effectiveness of Non-ionized distilled water caries status with dmfs (Decayed Missing Filled Surfaces) and ICDAS 2 (The International Caries Detection and Assessment System) indices.
4. To compare the effectiveness of sodium fluoride varnish and Silver Diamine fluoride caries status with dmfs (Decayed Missing Filled Surfaces) and ICDAS 2 (The International Caries Detection and Assessment System) indices.
5. To compare cost effectiveness between sodium fluoride varnish group, SDF group, Non-Ionized distilled water
Attaching Refrence
Refrence:
Chu CH, Lo EC, Lin HC. Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children. Journal of dental research. 2002 Nov;81(11):767-70.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 284
- Children with non-cavitated healthy dentition will be included (dmfs and ICDAS II score is zero) 2.
- Population is provided with same water supply.
- The children whose parents will give the written informed consent for study.
- Allergic to silver.
- Children using mouth wash.
- Any obvious loss of tooth structure due to caries, hypoplasia, trauma or excessive wear.
- Children who fall under Frankel’s Behavior rating scale 1 (definitely negative) and 2 (negative) will not be included.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method This study will present which intervention is better in prevention of caries. Baseline, 3months, 6months, 12months
- Secondary Outcome Measures
Name Time Method To find which material is cost effective and which will give good clinical outcome.
Trial Locations
- Locations (1)
Hasti public school
🇮🇳Dhule, MAHARASHTRA, India
Hasti public school🇮🇳Dhule, MAHARASHTRA, IndiaDr Aishwarya jainPrincipal investigator7744887366aishjain1994@gmail.com