Oral health Oral Health Dental caries
Conditions
Interventions
Participants will be individually randomised to the following three arms:
1. Conventional filling (surgical management) of dental caries
2. Intermediate treatment strat
Sponsors
University of Dundee (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Child aged 3-7 years 2. At least one tooth with decay into dentine (assessed by the General Dental Practitioner [GDP] and defined as International Caries Detection and Assessment System [ICDAS] code 3,4,5 or 6) 3. At least one primary molar tooth 4. Willing to be examined and can have bitewing radiographs taken (i.e. have not had dental radiographs for at least 11 months and are cooperative with the procedure)
Exclusion criteria
Exclusion criteria: 1. Patients at the recruitment appointment with either toothache or sepsis (as diagnosed by the GDP from patient history, examination, radiographs) will not be enrolled into the study but after treatment may be reassessed for eligibility 2. Patients who are accompanied by an adult who lacks the legal or mental capacity to give informed consent 3. Patients with a medical condition requiring special considerations with their dental management, e.g., cardiac defects, blood dyscrasias
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 06/10/2015: Either pain or sepsis related to dental caries. Episodes of dental pain (toothache) measured by patient/parent reporting and by dentist direct questioning, signs of infection detected through dentist clinical examination Previous primary outcome measures: 1. Number of children experiencing dental pain, as assessed by the Dental Discomfort Questionnaire (DDQ-8) 2. Number of children experiencing dental sepsis, as assessed by clinical examination (child's own dentist) and radiographic signs (independent blinded assessor) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 06/10/2015: 1. Incidence of caries in primary and secondary teeth; caries experience recorded using International Caries Detection and Assessment System (ICDAS) via CRF 2. Patient quality of life; patient and parent completed questionnaires 3. Cost-effectiveness of arm (treatment strategy); parent questionnaire and data collection on clinical activity via CRF, study specific estimates of unit costs 4. Acceptability of treatment strategy to participants and parents and their experiences; patient and parent questionnaires; parental interviews/ focus groups/child participatory activities 5. Dentists’ management strategy preferences; dentist questionnaire via CRF Previous secondary outcome measures: 1. Measurements of caries experience, as assessed by the validated International Caries Detection and Assessment System (ICDAS) 2. Child's quality of life, proxy assessed by Parental-Caregivers Perceptions Questionnaire (P-CPQ) 3. Child's global rating of oral health and impact on everyday life 4. Child's dental anxiety, as assessed by Modified Child Dental Anxiety Scale (MCDAS) 5. NHS costs of dental visits and treatment 6. Parental/family costs of dental visits and treatment | — |
Countries
United Kingdom
Outcome results
None listed