Ozonized Olive Oil in the Treatment of Periodontal Pockets

NCT06980675 | Recruiting

• 1 other identifier: 7493
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Ozonated Olive Oil; Periodontal Pocket; Periodontal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Difference of Total microbial load

  One measure at randomization and second measure after 21 days

Study Arms (2)

Ozonized Olive Oil Intervention Group

EXPERIMENTAL

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

Device: Activated Ozonized Olive Oil Gel

Placebo Controlled Group

PLACEBO COMPARATOR

Same description of Interventional Group

Other: Placebo gel

Interventions

Activated Ozonized Olive Oil Gel DEVICE

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

Ozonized Olive Oil Intervention Group

Placebo gel OTHER

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

Placebo Controlled Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Odontostomatologic Departement of Policlinic of Bari

Bari, BA, 70124, Italy

RECRUITING

MeSH Terms

Conditions

Periodontal Pocket; Periodontal Diseases

Condition Hierarchy (Ancestors)

Periodontitis; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Massimo Petruzzi, PhD, MD

  University of Bari

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Vittorio Ciccone, MD

CONTACT

3887589165; fabio.ciccone5@gmail.com

Massimo Petruzzi, PhD, MD

CONTACT

3335763120; massimo.petruzzi@uniba.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Odontostomatology

Model Details: Randomized Controlled Double-blind Intervention Trial

Study Record Dates

• First Submitted: May 25, 2024
• First Posted: May 20, 2025
• Study Start: October 25, 2021
• Primary Completion: November 1, 2024
• Study Completion: May 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)