Effectiveness of Using Silver Diammine Fluoride Solution and Combination of Povidone Iodine and Sodium Fluoride Varnish in Preventing Dental Root Caries in Elders: a Randomized, Double-blind, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 353
- 试验地点
- 1
- 主要终点
- new root caries found in clinical examination
研究概览
简要总结
The main objective of this study is to compare the effectiveness and cost-effectiveness of 4-monthly application of 10% povidone iodine solution followed by 5% sodium fluoride varnish with those of annual application of 38% silver diammine fluoride solution on the prevention of new dental root caries in elders. A secondary objective is to compare the effectiveness of the two interventions mentioned above on arresting (halting the progression) active root surface caries in the elders, thus avoiding the need for placing dental restorations.
This proposed study is a randomized double-blind controlled clinical trial with 24-month follow-up. A total of 353 elders aged 60 years or above living in residential homes or attending long-term care facilities in different districts in Hong Kong were recruited. Baseline clinical examination will be conducted by two calibrated examiners in the homes using an intra-oral LED light, dental mirrors and probes. Subjects were randomly allocated to one of the two study groups:
- positive control - received annual application of 38% silver diammine fluoride solution; and 2) test - received application of 10% povidone iodine solution followed by application of 5% sodium fluoride varnish every 4 months. Follow-up examinations will be carried out after 12 and 24 months by the same blinded examiners to assess the clinical outcomes, i.e. whether new dental caries has developed and whether the active root surface caries lesions found at baseline have become arrested (hardened).
详细描述
The study population of this proposed clinical trial is adults aged 60 years and above living in residential care homes or attending long-term care facilities in Hong Kong. Totally, 10 residential care homes or long-term care institutions served by NGO dental outreach teams in various districts with different background were selected by the PI in consultation with the NGOs. All elders living in the selected residential homes were invited to attend a free dental examination. Elders fulfilling the inclusion criteria were invited to participate in this study and informed written consent will be obtained before commencement of the study. Dental treatments other than the study interventions were provided by dentists from the NGOs which serve the residential homes.
Totally, 353 elder adults enrolled in the trial. The baseline examination was carried out in the residential home by two calibrated examiners, and so will be as follow-up examinations after 12 and 24 months. A portable dental chair, an intra-oral LED light, disposable dental mirrors and CPI probes were used in the examination.
For each tooth that was not indicated for extraction, status of its crown and its root were assessed and recorded separately. Caries diagnosis was based on visual and tactile inspection. No radiograph was taken. Plaque and food debris that obscures visual inspection of the tooth surfaces were removed. Four surfaces (mesial, distal, buccal and lingual) per tooth were examined and the status were recorded using the following codes which basically follow the criteria recommended by the International Caries Detection and Assessment System (ICDAS II) Coordinating Committee (2009).
The oral hygiene status of the subject was assessed and recorded by using the Visible Plaque Index (Ainamo & Bay, 1975). The presence or absence of visible plaque were recorded on four surfaces (mesial, distal, buccal and lingual) per tooth.
The gingival status of the subject was assessed and recorded using the Gingival Bleeding Index (Ainamo & Bay, 1975). The presence or absence of bleeding within 10 seconds after running a probe across the gingival margin was recorded on four surfaces (mesial, distal, buccal and lingual) per tooth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •have at least 6 teeth which are not indicated for extraction, and
- •have basic self-care ability.
排除标准
- •have serious debilitating health/medical conditions, and
- •have cognitive problems or major problems in communication.
研究组 & 干预措施
PVP-I solution combined with NaF varnish
4-monthly application of 10% povidone-iodine solution and 5% sodium fluoride varnish
干预措施: PVP-I solution combined with NaF varnish (Device)
SDF treated
Annual application of 38% SDF solution
干预措施: SDF solution (Device)
结局指标
主要结局
new root caries found in clinical examination
时间窗: 24 months
development of new carious lesion on exposed tooth root as assessed in clinical examination where there is a soft decayed root surface on gentle probing with a blunt probe
次要结局
- arrested root caries found in clinical examination(24 months)
