Pulpitis
Conditions
Interventions
This is a longitudinal prospective clinical trial lasting 12 to 24 months per participant, parallel randomized control group design followed by prospective meta-analysis, which will involve 120 adult
Total pulpotomy (PT, n=60) and Endodontic treatment (TE, n=60). This clinical study randomized trial will compare two treatment modalities: conventional endodontic treatment (TE) and total pulpotomy (
E06.397
Sponsors
Faculdade de Odontologia de Piracicaba-Universidade Estadual de Campinas
Faculdade de Odontologia de Piracicaba-Universidade Estadual de Campinas
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients aged 18 years and over; both genders; with a permanent tooth with complete rhizogenesis with deep cavities/restorations and symptoms indicative of irreversible symptomatic pulpitis (moderate to severe persistent spontaneous pain); the tooth must respond to the sensitivity to cold and electrical testing; must be restorable and can be rubber dam isolated adequately
Exclusion criteria
Exclusion criteria: Teeth with active periodontal disease (pocket depth >5mm); teeth indicated for elective endodontic treatment for restorative purposes; teeth with apical periodontitis; systemically compromised patients or who have undergone radiotherapy; patients unable to consent; history of trauma to the tooth; pregnant or postpartum patients; teeth with any evidence of purulence or excessive bleeding that cannot be controlled with a cotton ball with 2.5% sodium hypochlorite for 10 minutes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is based on clinical analysis after 12 months evaluating factors such as: 1) absence of pain indicative of symptomatic irreversible pulpitis; 2) absence of signs and symptoms indicative of acute or chronic apical periodontitis; 3) absence of radiographic evidence of failure, including radiolucency or resorption. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be based on the report of postoperative pain through a Numerical Rating Scale (NRS) and use of analgesics in the postoperative period (24h, 48h, 72h and 7 days). The presence of a tooth with an intact restoration and no defects after 12 months. Answer from positive sensitivity in the electrical test for the total pulpotomy group. Absence of need for any additional intervention or adverse event (such as the appearance of signs and symptoms that require an additional consultation or treatment, in addition to the already scheduled follow-up consultations) reported during the 12-month follow-up period;The microbiota and its virulence factors are expected to be evaluated using Nested-PCR, Checkerboard, next-generation sequencing, LPS, and LTA methods. We will observe if there was a decrease in the microorganisms and their virulence factors after several stages of the treatment;It is expected to identify the host immune response using ELISA and multiplex assays after the various stages of treatment | — |
Countries
Brazil
Contacts
Public ContactBrenda Gomes
Faculdade de Odontologia de Piracicaba-Universidade Estadual de Campinas
Outcome results
None listed