Ozonized Olive Oil in the Treatment of Periodontal Pockets

Clinical and Microbiological Study on Local Application of an Ozonated Olive Oil Gel in the Periodontal Pockets: a Randomized Double-blind Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontal Pocket
• Intervention / Treatment: Device: Activated Ozonized Olive Oil Gel; Other: Placebo gel

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabio Vittorio Ciccone, MD; Phone Number: +39 3887589165; Email: fabio.ciccone5@gmail.com
• Study Contact Backup: Name: Massimo Petruzzi, PhD, MD; Phone Number: +39 3335763120; Email: massimo.petruzzi@uniba.it

Study Locations

• Italy
  • BA
    • Bari, BA, Italy, 70124
      • Recruiting
      • Odontostomatologic Departement of Policlinic of Bari
      • Contact: Massimo Petruzzi, PhD, MD; Phone Number: +39 3335763120; Email: massimo.petruzzi@uniba.it
      • Sub-Investigator: Fabio Vittorio Ciccone, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ozonized Olive Oil Intervention Group; It has been administrated in the form of gel once a week for three weeks	Device: Activated Ozonized Olive Oil Gel; It is a natural oil which has been ozonized to improve the antimicrobial activity against periodontopathogenic bacterias
Placebo Comparator: Placebo Controlled Group; Same description of Interventional Group	Other: Placebo gel; Placebo gel with same texture, color, way of administration and taste of Activated Ozonized Olive Oil Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of Probing Pocket Depth (PPD)	It is a measures in mm assessed with periodontal probe in periodontal pockets	One measure to assess inclusion, second mesure at randomization and third measure after 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of Total microbial load	Expressed in percentage, samples performed with sterile paper cone and measurement performed with Applied Biosystem 7500 sequence detection system with Real Time PCR	One measure at randomization and second measure after 21 days

Collaborators and Investigators

• Sponsor: University of Bari
• Investigators: Principal Investigator: Massimo Petruzzi, PhD, MD, University of Bari

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Actual): November 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: May 25, 2024
• First Submitted That Met QC Criteria: May 16, 2025
• First Posted (Estimated): May 20, 2025

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Periodontal Disease; Periodontal Pocket; Ozonated Olive Oil
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Periodontal Pocket
• Other Study ID Numbers: 7493 (Cleveland Clinic IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No