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

Not Applicable

Completed

• Conditions: Periodontal Disease; Periodontal Disease Stage 2
• Interventions: Other: Placebo; Drug: Toothpaste Product; Drug: Mouthwash Product; Dietary Supplement: Probiotic

• Registration Number: NCT06955546
• Lead Sponsor: Massimo Corsalini

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-07
• Primary Completion: 2024-06-15
• Study Completion: 2024-07-24
• Study First Submitted: 2025-04-25
• Study First Submitted QC: 2025-04-25
• Status Verified: 2025-05
• Study First Posted: 2025-05-02
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Placebo Group	Placebo	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.
Group B: effective toothpaste and mouthwash. Placebo probiotics	Toothpaste Product	The patients of this group received effective toothpaste and mouthwash. Probiotics tablets were placebo.
Group B: effective toothpaste and mouthwash. Placebo probiotics	Mouthwash Product	The patients of this group received effective toothpaste and mouthwash. Probiotics tablets were placebo.
Group C: effective toothpaste, mouthwash and probiotics.	Toothpaste Product	The patients of this group received effective toothpaste, mouthwash and probiotics.
Group C: effective toothpaste, mouthwash and probiotics.	Mouthwash Product	The patients of this group received effective toothpaste, mouthwash and probiotics.
Group C: effective toothpaste, mouthwash and probiotics.	Probiotic	The patients of this group received effective toothpaste, mouthwash and probiotics.

Primary Outcome Measures

Name	Time	Method
Full Mouth Plaque Score	From enrollment to the end of treatment at 30 days	A percentage indices based on dichotomous recordings (absence/presence of plaque) recorded at four sites for each tooth present in the patient's mouth, evaluating the patient's oral hygiene status. 0% indicates the absence of plaque recorded at four sites for each tooth present in the patient's mouth, which is the best outcome possible. 100% indicates the constant presence of plaque recorded at four sites for each tooth present in the patient's mouth, which is the worst outcome possible.
Full Mouth Bleeding Score	From enrollment to the end of treatment at 30 days	A percentage indices based on dichotomous recordings (absence/presence of bleeding) recorded at four sites for each tooth present in the patient's mouth, evaluating the patient's inflammation status. 0% indicates the absence of bleeding recorded at four sites for each tooth present in the patient's mouth, which is the best outcome possible. 100% indicates the constant presence of bleeding recorded at four sites for each tooth present in the patient's mouth, which is the worst outcome possible.
Probing Pocket Depth	From enrollment to the end of treatment at 30 days	the depth of the pocket at four sites per tooth, measured from the free gingival margin to the base of the pocket using a UNC15 periodontal probe. Periodontal pockets were classified as moderate (PPD = 4-6 mm) or deep (PPD ≥ 7 mm).

Secondary Outcome Measures

Name	Time	Method
Adherence	From enrollment to the end of treatment at 30 days	The quality of adherence to the prescribed therapies was verified at each visit interval. Adherence was assessed as "valid" or "invalid."

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari; 🇮🇹 Bari, BA, Italy