The use of a premixed bioceramic material in the pulp cavity of decayed primary teeth in childre
- Conditions
- Dental caries requiring pulpotomy treatmentOral Health
- Registration Number
- ISRCTN98720643
- Lead Sponsor
- King Saud University
- Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37381123/ (added 11/07/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 70
1. Children aged between 4 and 10 years old
2. Healthy (ASA Physical Status Classification System I and II)
3. Cooperative (positive or definitely positive behavior according to Frankl behavior scale)
4. Deep dentin caries approximating or reaching the pulp without any signs or symptoms of pulpal degeneration in one or more primary molar
5. Primary molars clinical inclusion criteria: no history of spontaneous or persistent pain; restorable primary molars with deep carious lesions approximating or reaching the pulp; no pathological mobility, no tenderness to percussion, no swelling or sinus tract; hemostasis achieved after coronal pulp amputation within 5 minutes
6. Primary molars radiographic inclusion criteria: deep dentin caries approximating or reaching the pulp; no more than two-thirds of physiologic root resorption; no widening of the periodontal ligament space; no pathologic internal or external root resorption; no apical or furcal radiolucency
1. Children with special needs
2. Primary molars with uncontrolled bleeding after coronal pulp amputation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical and radiographic success rates of both pulpotomy materials measured using an assessment of signs and symptoms by the examiners at 6 and 12 months follow-up
- Secondary Outcome Measures
Name Time Method Failure type of each group measured by the examiners at 6 and 12 months follow-up