Direct pulp capping in primary molars: a feasibility study
Not Applicable
Completed
- Conditions
- Management of large carious lesions in primary teethOral HealthDental caries
- Registration Number
- ISRCTN10402878
- Lead Sponsor
- Tishreen University
- Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33543449/ (added 27/09/2021) 2019 Abstract results in https://doi.org/10.1111/idj.12517 P026 (added 17/11/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
1. Cooperative healthy children
2. Vital primary molars with large carious lesions that could be restored with composite
3. No history of spontaneous pain, pathologic mobility, redness or swelling of the vestibule, draining sinus tracts, or sensitivity to vestibular palpation
4. Absence of internal or external root resorption or inter-radicular/apical radiolucency
5. Both children and their parents had to be able to attend a 6-month follow-up procedure
Exclusion Criteria
Any clinical or radiographic signs indicating non-vital teeth
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility, estimated using the following measurements:<br>1. Proportion of eligible children among those examined, calculated after completion of the assigned number of participants<br>2. Proportion of children who completed the 6-month follow-up among those randomized, calculated after completion of the assigned period
- Secondary Outcome Measures
Name Time Method Success rates of the materials, which will be used to calculate the sample size for the definitive randomized controlled trial. Criteria used: absence/presence of clinical and radiographic signs, proportions calculated using simple formulas. Measured at the end of the treatment session as a baseline; the participants were clinically evaluated at 3 and 6 months post-treatment and evaluated radiographically after 6 months