A Pilot Study to Investigate the Use of Pit and Fissure Sealants in Children Requiring Caries Related Dental Extractions Under a Chair General Anaesthetic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Caries incidence
研究概览
简要总结
The purpose of thus study is to assess the feasibility and inform the planning of a proposed definitive randomised controlled clinical trial to investigate the efficacy of sealing permanent molars in children requiring caries related extractions under a chair General Anaesthetic.
详细描述
Objective:
To evaluate,
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The ability to recruit based on failure to meet exclusion criteria, declining to participate or other reasons and retention rates based on subsequent withdrawals.
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Feasibility and acceptability of placing sealants in this setting, based on compliance with the intervention.
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Sealant retention rates based on the proportion of sealants that were fully intact, partially intact or lost after 24 months.
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Two-year incidence of caries in permanent molars that were sound and suitable for sealants at the time of the pre-GA assessment, based on the proportion of children with:
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Experience of caries into dentine in at least one permanent molar
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Untreated caries into dentine in at least one permanent molar
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Oral health related Quality of Life (OHRQoL) two years following caries related extractions under GA, based on the Child-Oral Impacts on Daily Performances (Child-OIDP) scale and separate questions relating to specified oral symptoms.
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Oral health support provided by referring practitioners, within the 2 years following the dental GA, based on,
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Structured interview questionnaire to record parents' experience of preventive advice and treatment received, following the GA extractions
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Sealants identified at follow up that were not present at baseline or provided as part of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children that are to have extraction of at least one carious tooth under a chair General Anaesthetic at Birmingham Dental Hospital
- •Birmingham residents (as indicated by post code of home address)
- •Be aged 5 to 15 years
- •Be co-operative to a clinical dental examination
- •Present with at least one permanent molar tooth that is 'sound and sealable'
- •Be accompanied by an adult that has legal capacity to give informed consent
排除标准
- •Patients who at the pre-General Anaesthetic assessment visit present with:
- •Signs of a systemic illness (e.g. coughs, 'colds', chicken pox) that might preclude placement of sealants
- •Oral symptoms (e.g. pain, swelling) that would preclude sealant placement
- •Parents unable to confirm (with a reasonable degree of certainty) that they would be contactable and able to attend for review during the 2 years duration of the study (e.g. because of plans to move)
研究组 & 干预措施
Sealant applied to molars
All 'sealable' permanent molars will be sealed: Occlusal fissures and where appropriate, buccal pits (on lower molars) and palatal pits (on upper molars) will be sealed.
If patient compliance is adequate, a resin based sealant will be used as the first choice material. The tooth is thoroughly cleaned, prepared with a special solution, and dried. The liquid sealant is then applied and allowed to set hard.
干预措施: Pit and Fissure Sealant of permanent molars (Procedure)
No sealant applied to molars.
No molars will be sealed.
干预措施: No sealant of permanent molars (Procedure)
结局指标
主要结局
Caries incidence
时间窗: 12 months
The incidence of dental caries in permanent molars will be recorded.
次要结局
未报告次要终点