Clinical and Microbiological Study on Local Application of an Ozonated Olive Oil Gel in the Periodontal Pockets: a Randomized Double-blind Trial.

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Italy
Odontostomatologic Departement of Policlinic of Bari
RECRUITING
Bari
Contact Information
Primary
Fabio Vittorio Ciccone, MD
fabio.ciccone5@gmail.com
3887589165
Backup
Massimo Petruzzi, PhD, MD
massimo.petruzzi@uniba.it
3335763120
Time Frame
Start Date: 2021-10-25
Estimated Completion Date: 2025-05
Participants
Target number of participants: 20
Treatments
Experimental: Ozonized Olive Oil Intervention Group
It has been administrated in the form of gel once a week for three weeks
Placebo_comparator: Placebo Controlled Group
Same description of Interventional Group
Related Therapeutic Areas
Sponsors
Leads: University of Bari

This content was sourced from clinicaltrials.gov