An interventional study of Activated Ozonized Olive Oil Gel and Placebo gel in Periodontal Pocket, sponsored by University of Bari. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-20.
Sponsored by University of Bari · Not applicable, Interventional, and Treatment
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.
130 studies on the registry are indexed under Periodontal Pocket; 35 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 113 interventional studies indexed under Periodontal Pocket.
Browse Periodontal Pocket studies →University of Bari is the lead sponsor of 76 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
It has been administrated in the form of gel once a week for three weeks
Device: Activated Ozonized Olive Oil Gel
Same description of Interventional Group
Other: Placebo gel
It is a natural oil which has been ozonized to improve the antimicrobial activity against periodontopathogenic bacterias
Placebo gel with same texture, color, way of administration and taste of Activated Ozonized Olive Oil Gel
Difference of Probing Pocket Depth (PPD)
It is a measures in mm assessed with periodontal probe in periodontal pockets
Time frame: One measure to assess inclusion, second mesure at randomization and third measure after 21 days
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
Time frame: One measure at randomization and second measure after 21 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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University of Bari