Effectiveness and Acceptability of SDF Compared to ART for the Management of Early Childhood Caries

The activity and inactivity of the lesion shall be assessed. A value of 0 shall be recorded if the lesion is inactive and a value of 1 if the lesion is active. For the assessment of activity, the parameters described in the Caries Care Guide shall be considered.

For the Fluoride Diamine Silver group, the lesion's surface should have a shiny appearance and hard consistency on examination to be considered inactive, when a soft, leathery and plaque retentive tissue is present, the lesion shall be considered active. For the Atraumatic Restorative Technique group, the Caries Associated to Restoration or Sealant (CARS)* criteria will be applied, being considered inactive if the margin is intact (good margin) and upon presentation of a restoration or plaque retentive sealant requiring adjustment or replacement will be considered active.

[*CARS includes 3 categories: good margin; defective (plaque-retentive, can be adapted); defective(needs replacement)]

Parental acceptability will be measured through a survey at 1 month, 6 months, and 12 months post-treatment following by a own elaboration questionnare.The survey includes 6 questions. Whether they would recommend the treatment based on the results (aesthetics, absence of pain, arrest of lesion) and experience of the treatment received by their child (adaptation and access to care).

A qualitative method will be used through semi-structured interviews to be conducted one month after the intervention.Parents with the lowest (10th percentile) and highest (90th percentile) acceptability (Parental acceptability: quantitative measure) will be selected. The semi-structured interview will explore their child's experience, what factors lead them to feel satisfied/dissatisfied with the treatment, factors that influenced their child's perceived comfort or discomfort during treatment, relevance of aesthetics, importance of the care setting to their satisfaction or dissatisfaction.

Children's acceptability of treatment as assessed by the operator using Frankl´s scale at the end of the initial treatment, 6 and 12 months. The minimum value=1 and the maximum value is 4. The higher scores mean a worse children's acceptability. [Frankl´s scale was used to evaluate child's behavior in the dental setting in four categories: 1-definitely negative 2-negative 3-positive 4- definitely positive]

Description: Change in oral health-related quality of life will be measured by the difference in the ECOHIS score between baseline and 6 months. The ECOHIS is a proxy-reported questionnaire for measuring the OHRQoL of preschool children and their families. It comprises of 13 items, covering six domains in two sections. The child's impacts section contains 4 domains. The family's impacts section contains 2 domains. Response categories for each question are rated on a 5-point Likert scale to record how often an event has occurred during the child's life: 0 = never, 1 = hardly ever, 2 = occasionally, 3 = often, 4 = very often, and 5 = don't know. ECOHIS scores are calculated as a simple sum of the response codes for the child and family sections separately and also a total score. The minimum value is 0 and maximum value is 52. Higher scores mean a worse quality of life.

Absence of pulp pathology: pufa=0 Measured with pufa index* [*pufa= 1 o >1 If presents p: pulpal involvement, opening of pulp chamber is visible or coronal tooth structures are destroyed by caries u: ulceration, traumatic ulceration in the soft tissues (tongue and mucosa), caused by tooth or root fragments f: a sinus tract releasing pus originating from an abscess and opening into the oral cavity a: abscess, dento-alveolar abscess.]

Presence of the tooth in the mouth. This refers to the fact that the tooth that was treated is still present in the mouth at the time of the control examination and has not been surgically extracted. It will be valued as 0 if it is present and as 1 if it has been extracted.

A questionnaire will be applied to the parents a week after treatment and also at 6 and 12 months follow-ups after treatment, where they'll have to report the presence of any adverse effect related to treatment.