RecruitingNot ApplicableNCT06980675

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.


Sponsor

University of Bari

Enrollment

20 participants

Start Date

Oct 25, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Activated Ozonized Olive Oil Gel and Placebo gel for people with periodontal pocket. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActivated Ozonized Olive Oil Gel

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

OTHERPlacebo gel

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


Locations(1)

Odontostomatologic Departement of Policlinic of Bari

Bari, BA, Italy

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NCT06980675


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