Dental Caries
Conditions
Keywords
silver nitrate, children, dental caries, medical management, quality of life
Brief summary
This pilot trial compares conventional restorations with a new strategy based on the medical management of caries using silver nitrate and fluoride varnish with no restorations.
Detailed description
This is a two-arm, parallel group, patient-randomized controlled pilot trial. Children with at least one primary tooth where caries extends into dentine. Children will be randomized and treated according to one of two treatment approaches;(1) conventional caries management with best practice prevention, or (2) medical management of caries using silver nitrate with best practice prevention. Baseline measures and outcome data (at treatment/review during two year follow-up) are assessed through direct reporting, clinical examination including blinded radiographic assessment, and child/parent questionnaires.
Interventions
PROCEDUREProphylaxis
A dental prophylaxis is a cleaning procedure performed to thoroughly clean the teeth. Prophylaxis is an important dental treatment for halting the progression of periodontal disease and gingivitis.
DRUGFluoride varnish
Fluoride varnish is a highly concentrated form of fluoride which is applied to the tooth's surface, by a dentist, dental hygienist or other health care professional, as a type of topical fluoride therapy.
DRUGSilver Nitrate
a small amount will be applied to the tooth via a cotton applicator. Silver nitrate is a colorless, odorless, transparent solution used as an escharotic, dehydrating and sclerosing agent.
Sponsors
Delta Dental of Iowa
Arwa Owais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
the radiographic progression of caries is assessed by a masked investigator
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Presense of one or more cavitated carious lesions in the primary dentition, extending into dentin but not encroaching on the pulp. * Absense of any spontaneous or elicited pain due to caries, or signs of pulpal infection in response to any of the carious lesions in the primary dentition to be included in the study
Exclusion criteria
* Hereditary developmental defects of the teeth such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta * Medical conditions that prevent treatment of the child in the outpatient clinic. These conditions include severe bleeding disorders, cardiac problems and mental disabilities that prevent child from communication with the research team. * Known allergy/sensitivity to any of the dental materials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in baseline Caries Experience and activity (Incidence of caries in primary teeth) | through study completion, for 2 years | Detailed measurements of caries experience will be recorded at baseline and annual caries examination using EC4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caries activity in primary teeth | through study completion, for 2 years | Detailed measurements of caries activity will be recorded at baseline and annual caries examination using Nyvad scores. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain (toothache) and/or infection in primary teeth | through study completion, for 2 years | Assessments for pain from toothache will be made at each visit throughout the patient's participation in the trial using the Dental Discomfort Questionnaire completed by the parents. |
| Patient quality of life | through study completion, for 2 years | Quality of life will be assessed through direct reporting by parents and children about pain and related activities |
| Cost-effectiveness | through study completion, for 2 years | Cost-effectiveness for both groups will be calculated and compared |
| Acceptability of treatment strategies by parents and children | through study completion, for 2 years | Acceptability is checked throughout the whole period of the study every time the patient comes in for a recall |
Countries
United States
Outcome results
None listed