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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
* 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.
* 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.
Crescent Montessori School
Lahore, Punjab Province, Pakistan
Caries prevalence
Calculated by the frequency of participants having decayed, missing, filled surfaces of dentition
Time frame: Baseline
Frequency distribution of caries risk
Calculated using Caries Risk Assessment questionnaire, which is denoted as low, moderate or high
Time frame: 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.
Time frame: Baseline
Patient behaviour towards dental treatment
Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive
Time frame: 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
Time frame: Baseline
Mean value of caries experience
Calculated by summation of number of decayed, missing and filled surfaces of dentition
Time frame: 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
Time frame: Baseline
Extent of selected cavitated carious lesion using FOTI
Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 6 months
Changes in the mean value of caries experience
Calculated by summation of number of decayed, missing and filled surfaces of dentition
Time frame: 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
Time frame: 6 months
Extent of selected cavitated carious lesion using FOTI
Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 12 months
Changes in the mean value of caries experience
Calculated by summation of number of decayed, missing and filled surfaces of dentition
Time frame: 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
Time frame: 12 months
Extent of selected cavitated carious lesion using FOTI
Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5
Time frame: 12 months
Number of participants reporting adverse events
The frequency of participants reporting fluoride or silver toxicity
Time frame: Baseline
Percentage of dropouts
Frequency of participants which either withdraw and do not consent for follow up
Time frame: 6 months
Number of participants reporting adverse events
The frequency of participants reporting fluoride or silver toxicity
Time frame: 6 months
Percentage of dropouts
Frequency of participants which either withdraw and do not consent for follow up
Time frame: 12 months
Number of participants reporting adverse events
The frequency of participants reporting fluoride or silver toxicity
Time frame: 12 months
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