Dental pulp necrosis/regeneration
Conditions
Interventions
The study will be a parallel blind randomized clinical trial conducted according to the Consolidated Standards of Reporting Trials Statement (CONSORT), using two patient groups (n = 60): the first (n
Drug
Procedure/surgery
G16.762
A14.549.167.900.260
Sponsors
Universidade Ceuma
Universidade Ceuma
Eligibility
Age
8 Years to 15 Years
Inclusion criteria
Inclusion criteria: To be eligible in this study it will be necessary for patients to have the following characteristics: Patient who volunteers to participate in the study, in the age group of 8 to 15 years; Possess at least one tooth with open apex and pulp necrosis with or without periapical lesion; Radiographic examination showing open apex with 2 mm diameter; Healthy patient with absence of known allergies to the medicines used in the procedure, immune or systemic disease
Exclusion criteria
Exclusion criteria: Tooth with closed apex, apical cysts and existing disease requiring long-term anti-inflammatory treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Root apex closure, pulp revitalization and thickening of the dentinal tissue of the root canals.;The results of the treatment will be blindly evaluated by two reviewers, both pediatric dentists. The clinical success of the treatment will be defined as the termination of root formation, regression of periapical lesions and absence of any clinical signs or symptoms. Radiographic examinations will be performed before, after and in all evaluation periods (3, 6, 12, 18 and 24 months) using the digital radiographic sensor (EVO, Micro Image) with radiographic positioner Cone Indicator Digital Shick CDR (Indusbello ), available in the radiology booths of Clinica Escola I of the Florence Institute. Images of the preoperative and final postoperative radiographs in JPEG format will be transferred to ImageJ software (version 1.4.4, National Institutes of Health, Bethesda, MD), mathematically corrected using the TurboReg plug-in (Biomedical Imaging Group, Swiss Federal Institute of Technology, Lausanne, Switzerland) according to the method described by Bose et al. (2009), and calibrated. Alterations in root dimensions between the pre and post-operative final images will be assessed by measuring the changes in root length, dentinal wall thickness (measured in the two most cervical thirds) and width of the apical foramen. Changes between post-operative and preoperative values ??will be expressed as a percentage. Each measurement will be done in duplicate. Other clinical findings, such as restoration failure and calcification of the root canal, will also be evaluated on postoperative radiographs. The data collected will include demographic information, etiologies and diagnoses, types of teeth. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected. | — |
Countries
Brazil
Contacts
Public ContactKarime Lima da Silva
Instituto Florence de Ensino Superior
Outcome results
None listed