Probiotics And Ozonated Olive Oil To Maintain Oral Eubiosis In Stage I And II Periodontitis Patients

Massimo Corsalini

Status: Completed

Conditions: Periodontal Disease; Periodontal Disease Stage 2

Treatments: Dietary Supplement: Probiotic; Drug: Toothpaste Product; Other: Placebo; Drug: Mouthwash Product

Study type: Interventional

Funder types: Other

Identifiers

NCT06955546

Prot. 1983/CEL

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 3 patient groups, including a placebo group

Group A: Placebo Group

Placebo Comparator group

Description:

In this group the patients received a placebo toothpaste, mouthwash and probiotics. Their appearance was kept identical to mimic the real products containing effective substances, in order to dissuade the patient to drop out.

Treatment:

Other: Placebo

Group B: effective toothpaste and mouthwash. Placebo probiotics

Experimental group

Description:

The patients of this group received effective toothpaste and mouthwash. Probiotics tablets were placebo.

Treatment:

Drug: Mouthwash Product

Drug: Toothpaste Product

Group C: effective toothpaste, mouthwash and probiotics.

Experimental group

Description:

The patients of this group received effective toothpaste, mouthwash and probiotics.

Treatment:

Drug: Mouthwash Product

Drug: Toothpaste Product

Dietary Supplement: Probiotic