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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozonized Olive Oil Intervention Group | Experimental | It has been administrated in the form of gel once a week for three weeks |
|
| Placebo Controlled Group | Placebo Comparator | Same description of Interventional Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activated Ozonized Olive Oil Gel | Device | It is a natural oil which has been ozonized to improve the antimicrobial activity against periodontopathogenic bacterias |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabio Vittorio Ciccone, MD | Contact | 3887589165 | +39 | fabio.ciccone5@gmail.com |
| Massimo Petruzzi, PhD, MD | Contact | 3335763120 | +39 | massimo.petruzzi@uniba.it |
| Name | Affiliation | Role |
|---|---|---|
| Massimo Petruzzi, PhD, MD | University of Bari | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odontostomatologic Departement of Policlinic of Bari | Recruiting | Bari | BA | 70124 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2025 | May 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010514 | Periodontal Pocket |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Randomized Controlled Double-blind Intervention Trial
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| Placebo gel | Other | Placebo gel with same texture, color, way of administration and taste of Activated Ozonized Olive Oil Gel |
|