Treatment of Early Childhood Caries Using Silver Diammine Fluoride and Sodium Fluoride Tricalciumphosphate and the Effects on Oral Health Related Quality of Life

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Early Childhood Caries, Dental Caries in Children, Dental Caries Extending Into Dentin, Dental Caries, Behavior, Child, Quality of Life

Intervention / Treatment
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* Drug: Topical application of 38% Silver Diammine Fluoride Solution
* Drug: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish


Participation Criteria
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Eligibility Criteria
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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: 4 to 6 years-of-age Identification of one or more carious primary molars without involvement of the pulp confirmed by bitewing radiographs Up to three teeth per each participant will be selected for intervention Has normal salivary flow rate Does not consume medications regularly for any medical condition Has not or will not receive any fluoride therapy or relevant dental therapy from other dental sources within the last six months Exclusion criteria: Children will be excluded from the trial if they fulfil any of the following criteria: Presence of any pain, ulceration, fistula/sinus or an abscess Premature hypermobility of carious teeth which can be potentially included in the study History of allergy to any product containing silver compounds Siblings of the participants will not be allowed to participate to ensure any chance of ECOHIS duplication.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical application of 38% Silver Diammine Fluoride Solution at Baseline<br>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. | Drug: Topical application of 38% Silver Diammine Fluoride Solution<br>* Application of petroleum jelly on lips and around the mouth for prevention of temporary silver tattoo. Before SDF application, the affected area will be thoroughly dried and isolated using the cotton rolls or dri-angle. Isolation throughout the procedure and following three minutes is considered most desirable. The varnish should be allowed to be in place for 60 seconds. This is the most critical step in the process. Applied varnish will be dried with gentle flow of compressed air. SDF will be applied with a microbrush to all carious lesions and to all pits and fissures on posterior (molar) teeth for 60 seconds. To avoid gingival or mucosal irritation, contact of varnish with any oral tissue other than affected area will be avoided. If the application time is shorter due to unforeseen reasons reapplication will be considered.<br>* Other names: Saforide;|
| Active Comparator: Topical application of 38% Silver Diammine Fluoride Solution at 6 months<br>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. | Drug: Topical application of 38% Silver Diammine Fluoride Solution<br>* Application of petroleum jelly on lips and around the mouth for prevention of temporary silver tattoo. Before SDF application, the affected area will be thoroughly dried and isolated using the cotton rolls or dri-angle. Isolation throughout the procedure and following three minutes is considered most desirable. The varnish should be allowed to be in place for 60 seconds. This is the most critical step in the process. Applied varnish will be dried with gentle flow of compressed air. SDF will be applied with a microbrush to all carious lesions and to all pits and fissures on posterior (molar) teeth for 60 seconds. To avoid gingival or mucosal irritation, contact of varnish with any oral tissue other than affected area will be avoided. If the application time is shorter due to unforeseen reasons reapplication will be considered.<br>* Other names: Saforide;|
| Active Comparator: Topical application of 38% Silver Diammine Fluoride Solution at 12 months<br>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. | Drug: Topical application of 38% Silver Diammine Fluoride Solution<br>* Application of petroleum jelly on lips and around the mouth for prevention of temporary silver tattoo. Before SDF application, the affected area will be thoroughly dried and isolated using the cotton rolls or dri-angle. Isolation throughout the procedure and following three minutes is considered most desirable. The varnish should be allowed to be in place for 60 seconds. This is the most critical step in the process. Applied varnish will be dried with gentle flow of compressed air. SDF will be applied with a microbrush to all carious lesions and to all pits and fissures on posterior (molar) teeth for 60 seconds. To avoid gingival or mucosal irritation, contact of varnish with any oral tissue other than affected area will be avoided. If the application time is shorter due to unforeseen reasons reapplication will be considered.<br>* Other names: Saforide;|
| Experimental: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at baseline<br>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. | Drug: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish<br>* According to manufacturer, Clinpro® White Varnish can be applied to tooth surfaces where plaque is present. A prophylaxis is not required. The applicator brush provided along is used to thoroughly mix the varnish inside the single-unit dose pack, since components of all sodium fluoride varnishes are separate during storage. Excessive contact with soft tissue should be avoided. Only enough varnish to form a thin coating on the desired treatment area should be used. After application, patient should be instructed to close their mouth to set the varnish. Rinsing or suctioning immediately after application is not recommended. The operator might appreciate the formation of a thin coating on the teeth and the patient should be informed that they may feel a thin coating when rubbing the treated area with their tongue.<br>* Other names: NaF-fTCP;|
| Experimental: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 6 months<br>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. | Drug: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish<br>* According to manufacturer, Clinpro® White Varnish can be applied to tooth surfaces where plaque is present. A prophylaxis is not required. The applicator brush provided along is used to thoroughly mix the varnish inside the single-unit dose pack, since components of all sodium fluoride varnishes are separate during storage. Excessive contact with soft tissue should be avoided. Only enough varnish to form a thin coating on the desired treatment area should be used. After application, patient should be instructed to close their mouth to set the varnish. Rinsing or suctioning immediately after application is not recommended. The operator might appreciate the formation of a thin coating on the teeth and the patient should be informed that they may feel a thin coating when rubbing the treated area with their tongue.<br>* Other names: NaF-fTCP;|
| Experimental: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 12 months<br>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. | Drug: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish<br>* According to manufacturer, Clinpro® White Varnish can be applied to tooth surfaces where plaque is present. A prophylaxis is not required. The applicator brush provided along is used to thoroughly mix the varnish inside the single-unit dose pack, since components of all sodium fluoride varnishes are separate during storage. Excessive contact with soft tissue should be avoided. Only enough varnish to form a thin coating on the desired treatment area should be used. After application, patient should be instructed to close their mouth to set the varnish. Rinsing or suctioning immediately after application is not recommended. The operator might appreciate the formation of a thin coating on the teeth and the patient should be informed that they may feel a thin coating when rubbing the treated area with their tongue.<br>* Other names: NaF-fTCP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SDF, NaF-fTCP, child behavior, pain experience, Wong-Baker Faces Pain rating scale, oral health-related quality of life, caries arrest, caries prevention, silver diammine fluoride, minimal intervention dentistry, Functionalized tricalcium phosphate, Sodium fluoride