COMPARATIVE ASSESSMENT OF CONVENTIONAL AND ARGININE ENRICHED FLUORIDE VARNISHES ON CARIES INCREMENT, SALIVARY FLUORIDE ION CONCENTRATION AND ORAL MICROBIAL PROFILE : AN INVIVO STUDY
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
The present study will be done on 80 children aged 6-10 years who meets the inclusion criteria and will be distributed randomly into two groups as follows.
Group I (n=40): Children treated with MI varnish.
Group II (n=40): Children treated with 2%L-Arginine enriched MI varnish.
BASELINE:
All Patients will be instructed to refrain from eating and drinking for 1 hour before the saliva sample collection. Then the patients will be made to rinse the mouth with water and to swallow the preexisting saliva. Baseline saliva sample will be collected from the floor of mouth using disposable syringe to avoid any possible contamination and is injected into Eppendorf tubes with buffer solution and refrigerated at -20 degree Celsius and stored in laboratory until further analysis. Tooth surface will be cleaned with sterile gauze and air dried. A thorough clinical examination using ICDAS II score will be done by a single evaluator using a dental mirror and probe with a blunt end on the dental chair with optimal light for both the groups. Saliva samples will be subjected for fluoride ion concentration estimation using UV spectrophotometry analysis (SPADNS Method) and cultured on selective Mitis-Salivarius-Bacitracin (MSB) agar media for Streptococcus mutans count.
INTERVENTION:
Patients in the group I will be treated with MI varnish and group II will be treated with 2%L-Arginine enriched MI varnish. The varnish will be applied evenly to the buccal and palatal surfaces of all teeth using a microbrush and allowed to remain undisturbed for five minutes. Patients will be instructed to refrain from consuming food or rinsing for 2h. They will be advised to avoid hard or sticky food for 4h post-treatment.
POST INTERVENTION:
Patients will be recalled after 1 month and 3 month from the day of application and post -intervention saliva samples will be collected by same procedure as mentioned above and all the samples will be subjected for fluoride ion concentration estimation using UV spectrophotometry analysis (SPADNS Method) and cultured on selective Mitis-Salivarius-Bacitracin (MSB) agar media for Streptococcus mutans count. And at 6 month follow up, ICDAS II scoring will be recorded. The results obtained will be subjected to statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 10.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Children within 6-10 years of age of both the genders 2.Children at risk with 2 or more carious teeth.
- •3.Co-operative behavior (Frankl scale rating 3-4).
- •4.Good general health, no systemic diseases affecting saliva or oral health.
排除标准
- •1.Allergies to fluoride, arginine or varnish components.
- •2.Children requiring special health care needs.
- •3.Pulpally involved and grossly decayed teeth 4.Professional fluoride application, antibiotics or fluoride supplements within 3 months prior.
研究者
Dr Balasubramani
Rajarajeswari Dental College and Hospital Bangalore
