Dental Caries
Conditions
Interventions
Children from 3 to 10 years old who present cavitated caries lesions in the dentine of deciduous molars will be selected. Randomization will be done per child and more than one tooth will be included
n=76) and test (Riva Aqua
n=76). Opaque, sequentially numbered envelopes will be used for the randomization process. A research assistant will be responsible for opening the envelope at the time of treatment.
The selected teet
Sponsors
Centro Universitário UNIESP
Centro Universitário UNIESP
Eligibility
Age
3 Years to 10 Years
Inclusion criteria
Inclusion criteria: Children from both genders whose parents accept and sign the informed consent form. Children from 3 to 10 years old that allows treatment will be included (good overall behaviour). Primary molars with cavitation into dentine
Exclusion criteria
Exclusion criteria: Children whose parents do not sign the consent form. Children who are absent on the day of treatment. Children who do not cooperate with the treatment. Teeth with dentine caries lesions with signs and symptoms of irreversible pulpitis and/or pulp necrosis (clinical pulp exposure, spontaneous pain, presence of fistula or abscess close to the tooth to be treated). Teeth with enamel defects (amelogenesis imperfecta, hypomineralization or hypoplasia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the presence/percentage of adverse events (primary outcome) reported by the caregiver after the application of silver diamine fluoride (RIVA STAR or RIVA AQUA) based on the study by Vollú et al., 2019. This includes burns (soft tissue ulceration), allergic reactions, nausea or vomiting, bad taste, pain or sensitivity in the teeth, pigmentation of the skin/oral tissues, child avoiding smiling or being bothered by the appearance of the teeth. If those responsible report one or more of the items above, the presence of adverse events will be considered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the patient's discomfort immediately after the sequence of treatments performed in each session using the Wong-Baker faces scale (Buchanan, Niven, 2002). The scale features six numbers (0-5), from the happiest face to the most unhappy face, in order to estimate the level of discomfort after the procedure and will be evaluated immediately after the treatment by an external examiner (oral health assistant).;Evaluate the cost of the procedure with the cost of materials according to each unit used during the procedure for the treatment of each patient. A costing sheet will be included for each patient. The number of teeth treated and the treatment time will be evaluated. Professional costs will be based on the study Olegário et al. (Olegário et al. 2020) and adjusted to the context of the present study. For this adjustment, the current base salary of Dental Surgeons and ASBs reported in the state of Paraíba will be considered. The minutes spent on each procedure will be converted into hours and multiplied by the hourly salary of each of these professionals. For the calculation of the material cost, the quantity and specifications of all materials used in each included tooth will be recorded in individual clinical files. The value used for each material will be the average of the values from three different purchase locations. For products whose packaging contains countable units, the average price will be divided by the number of items in each package. For countless materials, an average value per “serving” according to an estimated yield of that product will be realized. Some items will be used in all consultations in a standardized manner, such as 70% alcohol for disinfecting surfaces, distilled water for autoclaving, disposable bibs, disposable gloves, disposable masks, disposable caps and disposable aprons. These products will be accounted for equally in all procedures and also considered in the material cost.;Evaluate caries arrestment after 7 days, 6 mon | — |
Countries
Brazil
Contacts
Public ContactIsabel Olegário
Trinity College Dublin
Outcome results
None listed