Early childhood caries Oral Health Dental caries
Conditions
Interventions
Patients are allocated into groups using restricted randomization - there are pre-numbered six colour cards
patients are allocated to the group which corresponds to the number of the next card after signing informed consent.
The first placebo group: placebo application twice with a 6-month interval and a r
Sponsors
Riga Stradinš University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 1-6 years 2. Have at least one active caries damage with cavitates (comply with the diagnosis of severe early childhood caries [S-EEC]) 3. Wish to participate in the study 4. Parents agree to participate in the study and sign a consent form
Exclusion criteria
Exclusion criteria: 1. The child arrives with an adult who doesn’t have the right to sign a consent form, and the person responsible for the child cannot be present 2. Chronic or serious acute general illness 3. In the last month has used medications that could affect the secretion of saliva 4. Previously received treatment with products that have a high level of fluoride concentration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain history during the observation period, assessed as Yes/No by two calibrated dentists at the 12 months follow-up visit 2. Abscess history during the observation period, assessed as Yes/No by two calibrated dentists at the 12 months follow-up visit 3. The number of newly extracted or otherwise surgically treated teeth during the observation period, assessed using medical records at the 12 months follow-up visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change in the overall activity of caries as Active/Non-active, assessed by two calibrated dentists at the 12 months follow-up visit 2. The progression and change of activity of every lesion, assessed by International Caries Detection and Assessment System (ICDAS) (progression) and Nyvad (activity) criteria, at the 12 months follow-up visit 3. The parent’s satisfaction with the way their children’s teeth look, assessed by a questionnaire asking: “Are you satisfied with the way your child’s teeth look?” and “Would you agree to repeat the treatment procedure used?” on a 5-point Likert scale, at the 12 months follow-up visit 4. The child’s satisfaction with their teeth, measured by the visual analogue scale (VAS) with three points (happy, not sure, sad) at the 12 months follow-up visit 5. The child’s feelings during the treatment, measured by the modified Wong-Baker scale with three options (no hurt, hurts a little, hurts a lot), during every appointment (depending on treatment group can be assessed at baseline, 1, 2, 3 weeks and 12 months; or at baseline, 6 and 12 months) 6. The direct costs of the treatment and the cost-effectiveness, calculated as EUR spent per treatment protocol; EUR per prevented major complications (patient-level - pain, abscess, extraction) and EUR per prevented minor complications (tooth-level - progression of caries lesion), calculated at the 12 months follow-up visit 7. The treatment method’s undesirable side effects, assessed by parent questionnaire at the 12 months follow-up visit | — |
Countries
Latvia
Outcome results
None listed