Teeth with pulp necrosis
Conditions
Interventions
Group I OLEOZON® oral (experimental): OLEOZON® oral will be applied using a sterile paper point soaked in the product, brushing the root canal walls between sessions (every seven days) until an asepti
Ozone Therapy
Sponsors
South University Policlinic of Morón
Eligibility
Sex/Gender
All
Age
19 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with pulp necrosis in permanent teeth with an indication for root canal treatment. 2. Patients of both sexes, aged 19 to 65 years, who provide informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant women. 2. Patients with mental disabilities that may hinder their cooperation with the research. 3. Personal medical history of: acute alcohol intoxication, heart attack, ozone allergies, severe thyroid disorders, glucose-6-phosphate dehydrogenase deficiency (favism). 4. Extensive tooth loss, some type of periapical rarefaction or root resorption, and in non-genital teeth where periodontal health is severely compromised. 5. Patients under antimicrobial treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Bacterial growth: Bacterial development in culture medium will be considered, categorized as: with inhibition (when no growth is observed through direct visualization of the identified bacterial organisms in the culture media) and without inhibition (when maintenance or increase of the identified bacterial organisms is observed through direct visualization of the culture media). Measurement time: at the beginning and on days 7, 14, 21, and 28. 2. Clinical evolution: Will be established from the results of the anamnesis and the oral examination, considering: favorable (when clinical signs and symptoms are eliminated or improve) or unfavorable (when clinical signs and symptoms are not eliminated or improve with respect to the initial symptoms). Measurement time: at the beginning and on days 7, 14, 21, and 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical signs and symptoms associated with root canal treatment. The following indicators will be considered: perceived pain intensity (according to the numerical rating scale (NRS), where absent has a value of zero; mild, values between 1-3; moderate, between 4-6; and severe, between 7-10), fetid odor (presence or absence), purulent exudate (presence or absence), inflammation (presence or absence), and bleeding (presence or absence). Measurement time: at the beginning and on days 7, 14, 21, and 28. 2. Treatment sessions: The number of sessions will be evaluated from the beginning until the end of treatment. Measurement time: at the beginning and on days 7, 14, 21, and 28. 3. Bacterial organisms: The bacterial organisms identified in culture media will be described. Measurement time: at the beginning and on days 7, 14, 21 and 28. 4. Adverse Events (AEs): The occurrence of any AEs in the subject will be assessed (yes/no); description of the AE (name of the adverse event); duration of the AE (difference in dates between the start and end of the event); intensity of the AE (Mild, Moderate, Severe); severity of the AE (Serious, Not serious); attitude regarding the study treatment (no change, temporary or permanent discontinuation of the study treatment); outcome of the AE (recovered, improved, persists, or sequelae); and causal relationship (very likely, likely, possible, unlikely, not related, not evaluable). Measurement time: At baseline and on days 7, 14, 21, and 28. | — |
Countries
Cuba
Contacts
Public ContactJacqueline Diaz Luis
Provincial General Teaching Hospital “Roberto Rodriguez Fernandez”
Outcome results
None listed