Clinical trial NCT06955546: Probiotics And Ozonated Olive Oil To Maintain Oral Eubiosis In Stage I And II Periodontitis Patients
Official title: Probiotics And Ozonated Olive Oil To Maintain Oral Eubiosis In Stage I And II Periodontitis Patients: A Randomized, Triple-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Disease
Periodontal Disease Stage 2
Keywords: periodontitis
probiotics
oral health
ozonated olive oil
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 parallel arms interventional study model
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to investigate the clinical benefits of the combined use of ozonized olive oil products (mouthwash and toothpaste) and probiotics on the health status of patients with Stage I and II periodontitis; could include any of the following:

* Male or female, aged between 18 and 70 years of any race.
* Diagnosis of stage I or II periodontitis according to the American Academy of Periodontology and the European Federation of Periodontology 2017 classification of periodontal diseases.
* Good general health.
* Ability to understand and comprehend the study's instructions and sign the informed consent.

The main question it aims to answer is: the single or combined use of ozonized olive oil products (mouthwash and toothpaste) and probiotics could improve the oral health status of patients with Stage I and II periodontitis compared to placebo?

Participants will proceed to their daily domiciliar oral hygiene maneuvers with the products given by investigators. The toothpaste was used twice daily, morning and evening, followed by rinsing with undiluted mouthwash for one minute. After rinsing, the patient did not rinse further with water and refrained from eating, drinking, and smoking for at least one hour. Domiciliary mechanical and drug therapies were continued, without modification, for 30 days. Moreover, the patients received a probiotic tablet daily.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged between 18 and 70 years of any race.
* Diagnosis of stage I or II periodontitis according to the American Academy of Periodontology and the European Federation of Periodontology 2017 classification of periodontal diseases.
* Good general health.
* Ability to understand and comprehend the study's instructions and sign the informed consent.

Exclusion Criteria:

* Pregnancy and breastfeeding.
* Periodontal or antibiotic therapy in the last two months.
* Systemic diseases that could influence the severity of periodontal disease or therapeutic success (e.g., Down syndrome, HIV, Diabetes Mellitus).
* Smoking \> 10 cigarettes per day.
* Need for antibiotic prophylaxis for dental procedures.
* Chronic use of anti-inflammatory drugs, calcium channel blockers, antidepressants, and anticonvulsants.

Primary outcomes:
measure: Probing Pocket Depth
timeFrame: From enrollment to the end of treatment at 30 days
measure: Full Mouth Plaque Score
timeFrame: From enrollment to the end of treatment at 30 days
measure: Full Mouth Bleeding Score
timeFrame: From enrollment to the end of treatment at 30 days
Secondary outcomes:
measure: Adherence
timeFrame: From enrollment to the end of treatment at 30 days
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
state: BA
Study officials:
References: