Minimally Invasive Treatment Approach for Early Childhood Caries Using Silver Diammine Fluoride and Sodium Fluoride With Functionalized Tricalcium Phosphate and Their Effects on Oral Health Related Quality of Life: A Pragmatic Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Frequency distribution of caries risk
研究概览
简要总结
There is still a need for the assessment of different minimal intervention strategies and treatments focusing on the prevention and arrest of carious lesions of primary molars The evidence-based clinical practice guideline on non-restorative treatments for cavitated carious lesions advocate the use of silver diammine fluoride biannually for high caries risk patients
详细描述
Although SDF has been proven to be highly effective in carious lesion arrest and prevention, the staining effect, metallic taste due to silver content and the minimal mucosal irritation have been noted as primary cause of disinterest among clinicians in the use of this material.
The use of NaF-fTCP as a caries preventive material has not been studied widely. The importance of oral hygiene education and diet modification to achieve an effective caries control has been widely discussed. The off-label use of NaF-fTCP as a caries arresting agent has not been studied on primary dentition. There is a dearth of evidence regarding the effectiveness of NaF-fTCP towards caries arrest and prevention in pragmatic settings.
A comparison between the SDF and NaF-fTCP application on the cavitated carious primary molars and their effect on the oral health-related quality of life of the children has not been published in the literature.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Topical application of 38% Silver Diammine Fluoride Solution at Baseline
- SDF is known for its corrosive nature therefore a plastic container or dappen dish will be used.
- 1 drop (0.05 ml) will be dispensed on a plastic container.
- 1 drop (2.24 F-ion mg/dose) SDF treats up to 5 tooth surfaces.
- Ultrafine microbrushes will be used to apply varnish.
干预措施: Topical application of 38% Silver Diammine Fluoride Solution (Drug)
Topical application of 38% Silver Diammine Fluoride Solution at 6 months
- SDF is known for its corrosive nature therefore a plastic container or dappen dish will be used.
- 1 drop (0.05 ml) will be dispensed on a plastic container.
- 1 drop (2.24 F-ion mg/dose) SDF treats up to 5 tooth surfaces.
- Ultrafine microbrushes will be used to apply varnish.
干预措施: Topical application of 38% Silver Diammine Fluoride Solution (Drug)
Topical application of 38% Silver Diammine Fluoride Solution at 12 months
- SDF is known for its corrosive nature therefore a plastic container or dappen dish will be used.
- 1 drop (0.05 ml) will be dispensed on a plastic container.
- 1 drop (2.24 F-ion mg/dose) SDF treats up to 5 tooth surfaces.
- Ultrafine microbrushes will be used to apply varnish.
干预措施: Topical application of 38% Silver Diammine Fluoride Solution (Drug)
Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at baseline
- 0.25 ml of the solution will be used which contains 12.5 mg of fluoride.
- Thin layer will be applied with sweeping horizontal brush strokes to all teeth present.
干预措施: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish (Drug)
Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 6 months
- 0.25 ml of the solution will be used which contains 12.5 mg of fluoride.
- Thin layer will be applied with sweeping horizontal brush strokes to all teeth present.
干预措施: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish (Drug)
Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 12 months
- 0.25 ml of the solution will be used which contains 12.5 mg of fluoride.
- Thin layer will be applied with sweeping horizontal brush strokes to all teeth present.
干预措施: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish (Drug)
结局指标
主要结局
Frequency distribution of caries risk
时间窗: Baseline
Calculated using Caries Risk Assessment questionnaire, which is denoted as low, moderate or high
Caries prevalence
时间窗: Baseline
Calculated by the frequency of participants having decayed, missing, filled surfaces of dentition
Patient behaviour towards dental treatment
时间窗: Baseline
Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive
Mean score of oral health impact
时间窗: Baseline
Calculated using Urdu-Early Childhood Oral Health Impact Scale form, the answer for each item is on a 5-point scale. The sum score of answers to the 13 questions can range from 0-52. The impact of oral health on life activities is predicted to be greater with a higher score in the summation which denotes a poorer quality of life.
Extent of selected cavitated carious lesion using ICDAS
时间窗: 12 months
Coded according to ICDAS-2 scoring system code 3: Moderate enamel breakdown, code 4: Moderate underlying dentinal shadow 5: extensive carious lesion extending to dentin without pulpal involvement
Mean value of caries experience
时间窗: Baseline
Calculated by summation of number of decayed, missing and filled surfaces of dentition
Changes in the mean score of patient behaviour towards dental treatment
时间窗: 12 months
Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive
Mean score of pain experience
时间窗: Baseline
Calculated using Wong Baker Faces Scale on a range of facial expression where 0 denotes no pain, 2, 4, 6 ,8 and 10 denotes the most painful experience
Extent of selected cavitated carious lesion using FOTI
时间窗: 12 months
Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5
Changes in the mean score of oral health impact
时间窗: 12 months
Calculated using Urdu-Early Childhood Oral Health Impact Scale form, the answer for each item is on a 5-point scale. The sum score of answers to the 13 questions can range from 0-52. The impact of oral health on life activities is predicted to be greater with a higher score in the summation which denotes a poorer quality of life.
Changes in the mean score of pain experience
时间窗: 12 months
Calculated using Wong Baker Faces Scale on a range of facial expression where 0 denotes no pain, 2, 4, 6 ,8 and 10 denotes the most painful experience
Changes in the mean value of caries experience
时间窗: 12 months
Calculated by summation of number of decayed, missing and filled surfaces of dentition
次要结局
- Percentage of dropouts(12 months)
- Number of participants reporting adverse events(12 months)
研究者
ANAS IMRAN ARSHAD
Principal Investigator
Universiti Sains Malaysia