Ozonized Olive Oil in the Treatment of Periodontal Pockets

University of Bari

Status: Enrolling

Conditions: Periodontal Pocket

Treatments: Other: Placebo gel; Device: Activated Ozonized Olive Oil Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT06980675

7493 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Ozonized Olive Oil Intervention Group

Experimental group

Description:

It has been administrated in the form of gel once a week for three weeks

Treatment:

Device: Activated Ozonized Olive Oil Gel

Placebo Controlled Group

Placebo Comparator group

Description:

Same description of Interventional Group

Treatment:

Other: Placebo gel