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NCT Number: NCT06980675

Ozonized Olive Oil in the Treatment of Periodontal Pockets

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.

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Key information

Conditions

Periodontal Pocket Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odontostomatologic Departement of Policlinic of Bari

Bari, BA, 70124, Italy

Location status: Recruiting

Location contact

Fabio Vittorio Ciccone, MD

SUB_INVESTIGATOR

Massimo Petruzzi, PhD, MD

CONTACT

[email protected]

3335763120 ext. +39

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Activated Ozonized Olive Oil Gel

Device

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

Placebo gel

Other

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

Primary outcomes

  1. Difference of Probing Pocket Depth (PPD)

    Time frame: One measure to assess inclusion, second mesure at randomization and third measure after 21 days

    It is a measures in mm assessed with periodontal probe in periodontal pockets

Secondary outcomes

  1. Difference of Total microbial load

    Time frame: One measure at randomization and second measure after 21 days

    Expressed in percentage, samples performed with sterile paper cone and measurement performed with Applied Biosystem 7500 sequence detection system with Real Time PCR

Study contacts

Contact information is provided by the study sponsor or research team.

Fabio Vittorio Ciccone, MD

CONTACT

[email protected]

3887589165 ext. +39

Massimo Petruzzi, PhD, MD

CONTACT

[email protected]

3335763120 ext. +39

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
May 20, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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