Effectiveness of pit and fissure sealants in caries prevention among 7-12 year old school children in Ettumanoor : One-year follow-up study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sealant retention will be dichotomized as completely retained ( modified Simonsen’s score 0) and not retained (modified Simonson’s score 1-4)
研究概览
简要总结
DESCRIPTION OF INTERVENTION
STUDY GROUP
Caries risk assessment will be done using Caries Risk Assessment Tool (CRA) developed by the American Academy of Paediatric Dentistry (AAPD).Calibration of the principal investigator and dental students for recording and diagnosing dental caries using ICDAS II criteria will be done by the faculty in the Department of Public Health Dentistry prior to the data collection. Inter and intra- examiner variability will be tested according to ICDAS II code 0 and ICDAS Code 1-3 combined.
Clinical examination will be done by calibrated principal investigator, final year dental undergraduates and postgraduate students.
The school children will be categorized as high caries risk based on the caries risk assessment tool.Dental Health education on oral hygiene practices and prevention of dental caries will be provided to all children in the school.Out of those children identified as high risk ,those satisfying the inclusion criteria will be selected for sealant application.Informed consent will be obtained from the parents of selected high risk children for sealant application.Pit and fissure sealant application will be done on the selected teeth of eligible candidates by calibrated investigators.
The principal investigator and the dental students will be trained by the faculty at the Department of Public Health dentistry, GDC, Kottayam for standardization of the clinical procedure in sealant placement.
Pit and fissure sealant application technique:
1. The teeth will be adequately isolated with cotton rolls.
2. 37% orthophosphoric acid (Prevest DenPro Actino Gel EtchantTM) will be used for etching occlusal pit and fissures for 15 seconds.
3. It will be followed by rinsing the area thoroughly with water for 15 seconds and drying it.
4. Pit and fissure sealants(Prevest Denpro PF SealTM) will be applied on to occlusal pits and fissures of permanent molars according to manufacturer’s instructions.
5. Photopolymerisation using (Woodpecker LED DTM) Light Cure Unit (Light Intensity-1000mW/cm² - 1700mW/cm²) for 20 seconds.
6. Sealants will be evaluated by visual and tactile examination with the help of a mouth mirror and an explorer.
7. Occlusion will be checked with an articulating paper and premature contacts will be relieved.
COMPARISON GROUP
Caries risk assessment will be recorded using Caries Risk Assessment Tool (CRA) developed by the American Academy of Paediatric Dentistry (AAPD).
Clinical examination will be done by calibrated principal investigator, final year dental undergraduates and postgraduate students and diagnosing dental caries using ICDAS II criteria.The school children will be categorized as high caries risk based on the caries risk assessment tool.Dental Health education on oral hygiene practices and prevention of dental caries will be provided to all children.
Informed consent will be obtained from parents of high risk children, for participation in 6 month,1year follow up of the study.
Follow up visits
Study group
At follow up visits at 6 months and 1 year, the sealants will be evaluated visually for sealant condition and caries development.
Sealant retention will be evaluated using modified Simonsen’s criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Study group Children of specified age attending Government aided schools in Ettumanoor, Kottayam and willing to participate in the study.
- •Children who will be categorized as high caries risk as per CRA (AAPD) Children who will be categorized as high caries risk as per CRA (AAPD), those with at least one sound first or second permanent molar (ICDAS II score is 0) or permanent first or second molars with initial caries lesion (ICDAS II score 1-3) The tooth for sealant placement should be fully erupted, i.e the entire occlusal surface should be exposed into mouth with no overlying tissue operculum and with the distal gingival tissue lying below the height of the distal marginal ridge.
- •Comparison group Children of specified age attending other neighbouring Government aided schools in Ettumanoor, Kottayam and willing to participate in the study.
- •Children who will be categorized as high caries risk as per CRA (AAPD).
排除标准
- •Children on any long-term regimen of medication that could affect the salivary flow.
- •Children undergoing any fixed or removable orthodontic treatment.
- •Children who have not participated for the 6 months follow up.
结局指标
主要结局
Sealant retention will be dichotomized as completely retained ( modified Simonsen’s score 0) and not retained (modified Simonson’s score 1-4)
时间窗: 6 months and 1 year post intervention
次要结局
- Caries incidence on sealed permanent first or second molars and caries increment will be assessed by comparing ICDAS II score at baseline, and at the end of one year for study group and comparison group.(Effectiveness of the sealant program will be assessed in terms of risk difference, relative risk and preventive fraction.)
研究者
Dr Anusree K R
Govt.Dental College, Kottayam