Deep Caries
Conditions
Brief summary
This clinical trial will be conducted to clinical, radiographical and histological evaluation of pulp condition with reversible pulpities after total and selective removal of primary and secondary caries (randomized clinical trial and exo-vivo study)
Detailed description
Randomized clinical trial Sample size 144 case… Randomization method used: Sample size calculation was performed using R statistical analysis software version 4.3.2 for Windows Outcome variables: Pulp vitality and post operative pain Grouping classified into four groups as follows: The first group : total caries removal of primary caries(PTCR) 27 The second group: selective caries removal of primary caries(PSCR) The third group: total caries removal of secondary caries(STCR) The fourth group : selecive caries removal of secondary caries(SSCR) Expected Time table: 2 years Recall of patient after 3,6,9 and 12 months 6 months for writing and 6 months for data analyzed
Interventions
PROCEDURETotal caries removal
Total caries removal and application of bioactive material
PROCEDUREPartial caries removal
Partial caries removal then application of biodentin
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. The patient's age from 18 years to 40 years old 2. Non -contributory medical history (ASA1) 3. Mature permanent posterior teeth with primary or secondary deep caries extending ≥ 2/3 of dentin 4. The tooth should give a positive response to cold testing 5. Clinical diagnosis of reversible pulpitis 6. The tooth is restorable via direct restoration, probing pocket depth and mobility are within normal limits 7. No signs of pulpal necrosis including sinus tract or swelling 8. No radiographic evidence of periapical changes indicative of apical periodontitis
Exclusion criteria
* Systemic medical conditions, pregnancy, alcoholic and smoker patients. 2- Teeth with spontaneous pain or percussion sensitivity in periodontal lesions, external or internal root resorption, sinus opening, mobility, or abscessed tooth. 3- Radiographic evidence of widened periodontal space, broken or interrupted lamina dura, and periapical radiolucency. 4- Intensified erosion damage or periodontitis. Patient reported clenching or bruxism, hopeless or non-restorable teeth. Immature teeth. 5- Patients with physical disabilities preventing tooth brushing. Patient had removable partial denture abutments, dental abscesses, pulp lesions, atypical facial pain, or pulpitis. 6- Patients had non-carious lesions like abrasion, erosion, attrition, or abfraction. 7- Patients with history of antibiotic or analgesics intake within few days of operative intervention. 8- Patients with previously root canal-treated teeth. 9- Periodontally compromised teeth. 10-Teeth that will be extracted for periodontal or orthodontic reasons as it will conduct for histological evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical evaluation ………. Radiographic evaluation: | 1year | clinical evaluation: absence of pain , pulp vitality, ………. Radiographic evaluation: absence of any periapical lesion or recurrent caries |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| histological evaluation and follow up | 1 year | histological evaluation after one year. T (Time): follow up evaluation periods of pulp condition immediately post operative (base line ), after 3, 6, 9 and 12 month and exo-vivo study. |
Contacts
Primary ContactAbeer M. Shehata, MASTER
Backup ContactAbeer M. Shehata, master
Outcome results
None listed