Ozonized Olive Oil in the Treatment of Periodontal Pockets

NCT ID: NCT06980675

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2025-05-31

Brief Summary

A randomized controlled clinical trial was conducted on 16 patients (8 males and 8 women) who were diagnosed chronic periodontitis. All the patients has been divided by randomization in two groups: control group treated with placebo gel and experimental group treated with gel based on ozonated EVO olive oil.

Both group after the evaluation of inclusion and exclusion criteria during the first visit, were subjected to hygiene treatment of removal tartar deposit, considered as standard of therapy for periodontitis.

After 15 days the hygiene treatment, patients were been randomized in two groups following the flow chart (t0) starting with: periodontal probing, microbiological samples and the first administration of gel. Next week (t1), has been collected the compliance and did the second administration of gel; the procedures will be the same also for another week (t2), until the last week (t3) when has been registered the second periodontal probing and did the second microbiological samples.

Data were collected to software Microsoft Excel and all the data analysis were conducted on this software to highlight significant differences between both groups. As the primary outcome was continuous variable and assuming normal distribution bilateral parametric test T-student was performed. An alpha error of 5% was considered, Beta error was not calculated as this was a pilot study.

Conditions

Periodontal Pocket

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ozonized Olive Oil Intervention Group

It has been administrated in the form of gel once a week for three weeks

Group Type: EXPERIMENTAL

Activated Ozonized Olive Oil Gel

Intervention Type: DEVICE

It is a natural oil which has been ozonized to improve the antimicrobial activity against periodontopathogenic bacterias

Placebo Controlled Group

Same description of Interventional Group

Group Type: PLACEBO_COMPARATOR

Placebo gel

Intervention Type: OTHER

Placebo gel with same texture, color, way of administration and taste of Activated Ozonized Olive Oil Gel

Interventions

Activated Ozonized Olive Oil Gel

It is a natural oil which has been ozonized to improve the antimicrobial activity against periodontopathogenic bacterias

Intervention Type: DEVICE

Placebo gel

Placebo gel with same texture, color, way of administration and taste of Activated Ozonized Olive Oil Gel

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with stage II, III, or IV periodontitis according to the new 2017 World Workshop periodontal classification
• Patients of either sex and older than 18 years of age
• Probing Pocket Depth (PPD) greater than or equal to 4 mm at 3 sites
• Patients who have signed consent to the study
• Collaborating patients

Exclusion Criteria

• age < 18 years and/or inability to provide written informed consent;
• absence of family or social welfare support;
• non-drug-induced gingival hypertrophy,
• severe smokers (more than 20 cigarettes per day),
• consumers of high levels of alcohol,
• patients on corticosteroid treatment,
• diabetic patient,
• immunodepressive therapies,
• chemotherapies,
• radiotherapies,
• pregnancy states;
• lack of collaboration for ongoing postoperative reevaluations.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bari

OTHER

Sponsor Role: lead

Responsible Party

Massimo Petruzzi

Clinical Professor of Odontostomatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Massimo Petruzzi, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bari

Locations

Odontostomatologic Departement of Policlinic of Bari

Bari, BA, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Fabio Vittorio Ciccone, MD

Role: CONTACT

fabio.ciccone5@gmail.com

3887589165 ext. +39

Massimo Petruzzi, PhD, MD

Role: CONTACT

massimo.petruzzi@uniba.it

3335763120 ext. +39

Facility Contacts

Massimo Petruzzi, PhD, MD

Role: primary

massimo.petruzzi@uniba.it

3335763120 ext. +39

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

7493

Identifier Type: -

Identifier Source: org_study_id