Dental caries
Conditions
Interventions
Pulpectomy in primary teeth using Feapex paste.
A total of 105 pulpectomies will be performed in 48 high-risk caries infants (1-3 years old) with irreversible pulpitis or pulp necrosis.
The treatmen
2. Odontometry, with baseline radiography, respecting 1 mm below the radiographic apex or root formation
3. Mandatory use of absolute isolation with rubber dam and use of dental clamps
4. Removal of the carious tissue and coronary opening with spherical drills of adequate size for access to the pulp chamber. For the determination of the shape of contour, a long-tapered configuration
5. Removal of remains of the coronary pulp with sharp dentin spoon and location of root canals with a canal probe
6. Irrigation of the root canal using physiological saline solution using sterile syringes with Endo-EZE irrigation tips (Ultradent®, Brazil) and white Macs tips (Ultradent®, Brazil)
7. Manual instrumentation using 3 Kerr-type files (initial + two), the first of which is compatible with the root canal. All the files were introduced together with 2% chlorhexidine digluconate gel (C
8. Immediately after instrumentation with each of the first two files, the root canal was irrigated using 5 ml of sterile saline solution with the aid of sterile disposable syringe with Endo-Eze Irrig
Drug
Procedure/surgery
E06.397
Sponsors
Faculdade de Odontologia da Universidade de São Paulo
Fundação Faculdade de Odontologia
Eligibility
Age
1 Years to 3 Years
Inclusion criteria
Inclusion criteria: Only children aged 1 year to 3 years and 11 months of age; who presented with primary teeth diagnosed with pulp necrosis or with irreversible pulpitis were included; who completed at least 6 months of clinical and radiographic follow-up were included in the analyses.
Exclusion criteria
Exclusion criteria: The exclusion criteria were as children with systemic and/or neurological diseases; teeth that had dental anomalies, periapical cyst, advanced internal / external resorption (more than 1/3 of the root length), involvement of the permanent successor crypt and presence of less than 2/3 of the root formed in the radiographic examination 21, and teeth that could not be appropriately isolated with rubber dam.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presentation of the expected outcome: Success of endodontic treatment Presentation of the method used to verify the expected outcome: Presence of clinical and / or radiographic failure of endodontic treatment. Kaplan-Meier survival analysis and Cox regression analysis to obtain the survival rate and standard error. Presentation of the parameters (numbers, percentages, indices, etc.) used to verify whether the outcome actually occurred: Evaluation of the number of patients and percentage distributed between success and failure (descriptive analysis) and evaluation of survival and standard error through Cox regression analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| presentation of the expected outcome: Evaluation of the influence of the patient's age on the success of endodontic treatment after 12 months. Presentation of the method used to verify the expected outcome: Cox regression analysis for the outcome of treatment success and patient age. Presentation of the parameters (numbers, percentages, indices, etc.) used to verify whether the outcome actually occurred: Evaluation of the mean and standard deviation of age between the outcome (success and failure) and statistical analysis using the Hazard Ratio (HR) and p-value (95% confidence interval).;presentation of the expected outcome: Evaluation of the influence of restorative material on the success of endodontic treatment after 12 months. Presentation of the method used to verify the expected outcome: Cox regression analysis for successful treatment outcome and restorative material used (glass ionomer cement or composite resin). Presentation of the parameters (numbers, percentages, indices, etc.) used to verify whether the outcome actually occurred: Descriptive evaluation of the total number and percentage between the types of materials used, the outcome (success and failure) and statistical analysis using the Hazard Ratio (HR) and p-value (95% confidence interval). | — |
Countries
Brazil
Contacts
Public ContactIsabel Olegário
Faculdade de Odontologia da Universidade de São Paulo
Outcome results
None listed