Periodontal PocketNCT06980675
Ozonized Olive Oil in the Treatment of Periodontal Pockets
A study testing Activated Ozonized Olive Oil Gel in people with Periodontal Pocket, run by University of Bari at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Pocket
- What is being tested?
- Activated Ozonized Olive Oil Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 25 Oct 2021to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 12Show fewer
- diabetic patient,
- immunodepressive therapies,
- chemotherapies,
- radiotherapies,
- pregnancy states;
- lack of collaboration for ongoing postoperative reevaluations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Odontostomatologic Departement of Policlinic of Bari
Bari, BA, 70124
Massimo Petruzzi, PhD, MD, 3335763120 ext. +39, massimo.petruzzi@uniba.it
Fabio Vittorio Ciccone, MD
About this study
Official title: Clinical and Microbiological Study on Local Application of an Ozonated Olive Oil Gel in the Periodontal Pockets: a Randomized Double-blind Trial.
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.
Read more
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
- Being tested
- Activated Ozonized Olive Oil Gel, Placebo gel
- Keywords
- Ozonated Olive Oil, Periodontal Pocket, Periodontal Disease
- Medical subject headings
- Periodontal Pocket, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated Ozonized Olive Oil GelDevice
It is a natural oil which has been ozonized to improve the antimicrobial activity against periodontopathogenic bacterias
Placebo gelOther
Placebo gel with same texture, color, way of administration and taste of Activated Ozonized Olive Oil Gel
| Study group | Role | What they receive |
|---|---|---|
| Ozonized Olive Oil Intervention Group | Experimental | It has been administrated in the form of gel once a week for three weeks Receives: Device: Activated Ozonized Olive Oil Gel |
| Placebo Controlled Group | Placebo comparator | Same description of Interventional Group Receives: Other: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of Probing Pocket Depth (PPD)
It is a measures in mm assessed with periodontal probe in periodontal pockets
Measured: One measure to assess inclusion, second mesure at randomization and third measure after 21 days
Secondary outcomes (1)
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
Measured: One measure at randomization and second measure after 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start25 Oct 2021
- Primary completion1 Nov 2024
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal PocketStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Double-blind Intervention Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Petruzzi, University of Bari
- Investigators
- Massimo Petruzzi, PhD, MD, Principal investigator, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980675
- Sponsor's protocol ID
- 7493
- Status last verified
- May 2025
- First submitted
- 25 May 2024
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Study on Local Application of an Ozonated Olive Oil Gel in the Periodontal Pockets: a Randomized Double-blind Trial.
- ClinicalTrials.gov ID
- NCT06980675
- Acronym / sponsor ID
- 7493
- Conditions
- Periodontal Pocket
- Keywords
- Ozonated Olive Oil, Periodontal Pocket, Periodontal Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- May 2025 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Double-blind Intervention Trial
| Arm | Type | Receives |
|---|---|---|
| Ozonized Olive Oil Intervention Group | Experimental | Device: Activated Ozonized Olive Oil GelIt has been administrated in the form of gel once a week for three weeks |
| Placebo Controlled Group | Placebo comparator | Other: Placebo gelSame description of Interventional Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activated Ozonized Olive Oil GelIt is a natural oil which has been ozonized to improve the antimicrobial activity against periodontopathogenic bacterias | Device | Ozonized Olive Oil Intervention Group |
| Placebo gelPlacebo gel with same texture, color, way of administration and taste of Activated Ozonized Olive Oil Gel | Other | Placebo Controlled Group |
Primary outcome
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
1 secondary outcome
Difference of Total microbial load
Time frame: One measure at randomization and second measure after 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Massimo Petruzzi, PhD, MD principal investigator
University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activated Ozonized Olive Oil Gel in people with Periodontal Pocket, run by University of Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio Vittorio Ciccone, MD (3887589165 ext. +39, fabio.ciccone5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.