跳至主要内容
临床试验/NCT05894200
NCT05894200Enrolling By Invitation不适用

Effectiveness and Retention of Pit and Fissure Sealants in Rural Setup: A School-based Clinical Trial in Nepal

Kathmandu University School of Medical Sciences1 个研究点 分布在 1 个国家目标入组 377 人开始时间: 2023年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
377
试验地点
1
主要终点
Effectiveness and Retention of Pit and Fissure Sealants in Rural Setup: A School-based Clinical Trial in Nepal

研究概览

简要总结

The program titled "Campus to Community: breaking the barrier in oral health education and dental care" is uniquely designed program to link University (Kathmandu University School of Medical Sciences) to community (Sanghutar, Ramechhap). Dhulikhel Hospital, Kathmandu University Teaching Hospital has established a model dental clinic in the premises of Him Ganga Secondary School, Shangutar which is operated by council registered Dentist and dental hygienist. The objective of this study is to assess oral health condition of the children aged 6-15 years of the school followed by application of pit and fissure sealant (PFS) in non-carious permanent molar and Silver diamine fluoride (SDF) in carious permanent teeth. Data will be recorded according to the WHO Oral health assessment form for children, 2013 by a calibrated dentist from Dhulikhel Hospital and retention of PFS and efficacy of SDF application will be followed up after 6 months by the same investigators. The program is proposed with the expectation that proper oral hygiene prevention program combined with preventive procedures like pit and fissure sealant and SDF can reduce the burden of oral diseases in rural setup.

详细描述

World Health Organization reported that untreated caries in permanent teeth is the most prevalent condition, affecting 3.5 billion people globally, which seems more aggressive in developing countries. Such untreated dental caries in permanent teeth is the most common health condition according to the global burden of disease 2019 which can be largely preventable and school based preventive program are the most effective one to overcome such problems. Acute or unplanned dental care accounted loss of 34 million school hours annually compared to children with very good oral health. Silver diamine fluoride is safe and effective alternative treatment for the children which can improve oral health outcomes for community members especially for individuals from low socioeconomic settings and can transform the concept of community dental caries program. pit and fissure sealants is very effective tool for caries prevention on an individual basis or as part of a public health measure for at - risk populations which can be applied both primary and secondary level of prevention. However in developing and underdeveloped countries, because of the lack of this preventive measure, every year children develop dental caries, pulpitis and ultimately extraction of permanent teeth which could otherwise be saved.

Methodology: Screening will be done in the school premises by the expert dentist from Kathmandu University School of Medical Science with sterilized Dental kit and head lamp taking universal precautions. Participants will be segregated according to class and respective class teachers will help them in screening accordingly. Both verbal and written consent will be taken from students, respective class teachers and parents if available.

World health organization, Oral Health Assessment form for Children, 2013 will be used to collect oral health data which includes demographic details, dentition status, gingival status, enamel fluorosis, Dental trauma, oral mucosal lesions, intervention urgency and dento-facial anomalies. After recording the data, Investigator will make a treatment plan and segregate the students according to the need for Silver diamine fluoride application, GIC pit and fissure sealant application or oral urgency treatment which will be coordinated by the available volunteers. All the students who participated in this study will be provided with fluoridated toothpaste and brush.

Pit and fissure sealant application: Deep pit and fissure will be identified and plaque removal is done with the toothbrush provided, conditioning will be done by conditioner liquid available with GIC pit and fissure sealant. Tooth surface will be cleaned with three-way syringe available in dental chair, Isolation will be maintained with cotton roll and sealant will be evaluated and occlusal bite will be registered. Students will be informed about post-restoration instructions in verbal and printed form of instruction will be given to individuals.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
6 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All the students from the school who is willing to participate in this study aged between 6-15 years old

排除标准

  • Students who is not willing to participate or not permitted from parents

结局指标

主要结局

Effectiveness and Retention of Pit and Fissure Sealants in Rural Setup: A School-based Clinical Trial in Nepal

时间窗: one year

Effectiveness of pit and fissure sealant in permanent molars, change from baseline in retention of the sealant at six months

次要结局

  • Effectiveness of silver diamine fluoride in caries prevention and arrest: An observational rural school based study(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilip Prajapati

Assistant professor

Kathmandu University School of Medical Sciences

研究点 (1)

Loading locations...

相似试验