Oral OLEOZON® in the endodontic treatment of teeth with pulp necrosis. Phase II

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

OLEO-ENDO-NP-II

Scientific title:

Efficacy and safety of oral OLEOZON® as an alternative in the endodontic treatment of teeth with pulp necrosis.

Acronym of Scientific Title:

OLEO-ENDO-NP-EFS-II

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

South University Policlinic of Moron

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Jose

Midle name:

Carlos

Last name:

Alvarez Hernandez

Medical Specialty :

First Degree Specialist in Comprehensive General Dentistry

Affiliation:

South University Policlinic of Mooón

Postal address:

Calle Marti # 353, entre calle Felipe Poey y Carlos Manuel de Cespedes.

City:

Moron, Ciego de Avila

País:

Cuba

Zip Code:

67210

Telephone:

+53-54305228

Email address:

josecarlosalvarez25@gmail.com

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

08/01/2024

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Teeth with pulp necrosis

Health condition(s) code:

Dental Pulp Necrosis

Dental Pulp Diseases

Tooth Diseases

Stomatognathic Diseases

Necrosis

Intervention(s):

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 aseptic canal is established (negative bacteriological control), with a limit of five sessions per therapeutic group. Group II Cresophene® (Control): Cresophene® will be applied using a sterile paper point soaked in the product, brushing the root canal walls between sessions (every seven days) until an aseptic canal is established (negative bacteriological control), with a limit of five sessions per therapeutic group.

Intervention code:

Ozone Therapy

Administration, Topical

Intervention keyword:

Oleozon

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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.

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

65 years

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:

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

2

Target sample size:

NA

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Jacqueline

Last Name:

Diaz Luis

Specialty:

Second Degree Specialist in Immunology

Affiliation:

Provincial General Teaching Hospital “Roberto Rodriguez Fernandez”

Postal Address:

Calle Zayas Esq. Libertad S/N

City:

Morón, Ciego de Ávila

País:

Cuba

Zip Code:

67210

Telephone:

+53-33505986

Email :

jdiaz@hgm.cav.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Jacqueline

Last Name:

Diaz Luis

Specialty:

Second Degree Specialist in Immunology

Affiliation:

Provincial General Teaching Hospital “Roberto Rodriguez Fernandez”

Postal Address:

Calle Zayas Esq. Libertad S/N

City:

Moron, Ciego de Ávila

País:

Cuba

Zip Code:

67210

Telephone:

+53-33505986

Email :

jdiaz@hgm.cav.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Provincial General Teaching Hospital “Roberto Rodriguez Fernandez”

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

11/10/2023

Postal address of Ethic Committee :

Calle Zayas Esq. Libertad S/N Moron, ZC: 67210, Ciego de Avila. Cuba

Telephone:

+53-335009605

Correo electrónico:

meibyojeda87@nauta.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

22/02/2027

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000480

Date of Registration in Primary Registry:

27/05/2026

Record Verification Date:

2026/05/27

Next update date:

2027/05/27

Link to the spanish version:

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Oral OLEOZON® in the endodontic treatment of teeth with pulp necrosis. Phase II

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