Treatment of Early Childhood Caries Using Silver Diammine Fluoride and Sodium Fluoride Tricalciumphosphate and the Effects on Oral Health Related Quality of Life
- Conditions
- Early Childhood CariesDental Caries in ChildrenDental Caries Extending Into DentinDental CariesQuality of LifeBehavior, Child
- Interventions
- Drug: Topical application of 38% Silver Diammine Fluoride SolutionDrug: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish
- Registration Number
- NCT05772039
- Lead Sponsor
- Universiti Sains Malaysia
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Topical application of 38% Silver Diammine Fluoride Solution at Baseline Topical application of 38% Silver Diammine Fluoride Solution * 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. Topical application of 38% Silver Diammine Fluoride Solution at 12 months Topical application of 38% Silver Diammine Fluoride Solution * 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. Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 12 months Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish * 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. Topical application of 38% Silver Diammine Fluoride Solution at 6 months Topical application of 38% Silver Diammine Fluoride Solution * 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. Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at baseline Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish * 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. Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 6 months Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish * 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.
- Primary Outcome Measures
Name Time Method Frequency distribution of caries risk Baseline Calculated using Caries Risk Assessment questionnaire, which is denoted as low, moderate or high
Caries prevalence Baseline Calculated by the frequency of participants having decayed, missing, filled surfaces of dentition
Patient behaviour towards dental treatment Baseline Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive
Mean score of oral health impact 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 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 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 12 months Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive
Mean score of pain experience 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 12 months Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5
Changes in the mean score of oral health impact 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 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 12 months Calculated by summation of number of decayed, missing and filled surfaces of dentition
- Secondary Outcome Measures
Name Time Method Percentage of dropouts 12 months Frequency of participants which either withdraw and do not consent for follow up
Number of participants reporting adverse events 12 months The frequency of participants reporting fluoride or silver toxicity
Trial Locations
- Locations (1)
Crescent Montessori School
🇵🇰Lahore, Punjab, Pakistan