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| Name | Class |
|---|---|
| 3M ESPE | INDUSTRY |
| SDI Limited | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical application of 38% Silver Diammine Fluoride Solution at Baseline | Active Comparator |
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| Topical application of 38% Silver Diammine Fluoride Solution at 6 months | Active Comparator |
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| Topical application of 38% Silver Diammine Fluoride Solution at 12 months | Active Comparator |
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| Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at baseline | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical application of 38% Silver Diammine Fluoride Solution | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Caries prevalence | Calculated by the frequency of participants having decayed, missing, filled surfaces of dentition | Baseline |
| Frequency distribution of caries risk | Calculated using Caries Risk Assessment questionnaire, which is denoted as low, moderate or high | Baseline |
| Mean score of oral health impact | 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. | Baseline |
| Patient behaviour towards dental treatment | Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive | Baseline |
| Mean score of pain experience | 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 | Baseline |
| Mean value of caries experience | Calculated by summation of number of decayed, missing and filled surfaces of dentition | Baseline |
| Extent of selected cavitated carious lesion using ICDAS |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting adverse events | The frequency of participants reporting fluoride or silver toxicity | Baseline |
| Percentage of dropouts | Frequency of participants which either withdraw and do not consent for follow up |
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Inclusion criteria:
Children will be invited to participate in the trial if they fulfil the entire selection criteria as described below:
Exclusion criteria:
Children will be excluded from the trial if they fulfil any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anas Imran Arshad, MSc., BDS | Universiti Sains Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crescent Montessori School | Lahore | Punjab Province | 54600 | Pakistan |
Patient data will only be used for knowledge transfer and personal information of each patient will be kept private and confidential. After performing data analysis and report writing the collected patient data will be securely transferred to hospital archives which are not accessible without proper identification and authorization. Data from the archives will be automatically erased after two years.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 11, 2022 | Feb 23, 2023 |
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Pragmatic randomized controlled trial
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|
| Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 6 months | Experimental |
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| Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 12 months | Experimental |
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| Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish | Drug |
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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
| Baseline |
| Extent of selected cavitated carious lesion using FOTI | Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5 | Baseline |
| Changes in the mean score of oral health impact | 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. | 6 months |
| Changes in the mean score of patient behaviour towards dental treatment | Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive | 6 months |
| Changes in the mean score of pain experience | 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 | 6 months |
| Changes in the mean value of caries experience | Calculated by summation of number of decayed, missing and filled surfaces of dentition | 6 months |
| Extent of selected cavitated carious lesion using ICDAS | 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 | 6 months |
| Extent of selected cavitated carious lesion using FOTI | Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5 | 6 months |
| Changes in the mean score of oral health impact | 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. | 12 months |
| Changes in the mean score of patient behaviour towards dental treatment | Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive | 12 months |
| Changes in the mean score of pain experience | 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 | 12 months |
| Changes in the mean value of caries experience | Calculated by summation of number of decayed, missing and filled surfaces of dentition | 12 months |
| Extent of selected cavitated carious lesion using ICDAS | 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 | 12 months |
| Extent of selected cavitated carious lesion using FOTI | Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5 | 12 months |
| 6 months |
| Number of participants reporting adverse events | The frequency of participants reporting fluoride or silver toxicity | 6 months |
| Percentage of dropouts | Frequency of participants which either withdraw and do not consent for follow up | 12 months |
| Number of participants reporting adverse events | The frequency of participants reporting fluoride or silver toxicity | 12 months |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D002652 | Child Behavior |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C024633 | silver diamine fluoride |
| D012969 | Sodium Fluoride |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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