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

Probiotics And Ozonated Olive Oil To Maintain Oral Eubiosis In Stage I And II Periodontitis Patients: A Randomized, Triple-Blind Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Disease; Periodontal Disease Stage 2
• Intervention / Treatment: Other: Placebo; Dietary supplement: Probiotic; Drug: Toothpaste Product; Drug: Mouthwash Product

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BA
    • Bari, BA, Italy, 70124
      • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group A: Placebo Group; 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.	Other: Placebo; 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.
Experimental: Group B: effective toothpaste and mouthwash. Placebo probiotics; The patients of this group received effective toothpaste and mouthwash. Probiotics tablets were placebo.	Drug: Toothpaste Product; Patients have to use the Curasept Prevent Toothpaste daily, during their domiciliar oral hygiene maneuvers. Link at: https://curaseptspa.it/prodotti/curasept-prevent-dentifricio/; Other Names: Curasept Prevent Toothpaste; Drug: Mouthwash Product; Patients have to use the Curasept Prevent Mouthwash daily, during their domiciliar oral hygiene maneuvers. Link at: https://curaseptspa.it/prodotti/curasept-prevent-collutorio/; Other Names: Curasept Prevent Mouthwash
Experimental: Group C: effective toothpaste, mouthwash and probiotics.; The patients of this group received effective toothpaste, mouthwash and probiotics.	Dietary supplement: Probiotic; Patients received a daily tablet of Curasept Prevent Probiotics. Link at: https://curaseptspa.it/prodotti/curasept-prevent-probiotico-integratore-alimentare/; Other Names: Curasept Prevent Probiotic; Drug: Toothpaste Product; Patients have to use the Curasept Prevent Toothpaste daily, during their domiciliar oral hygiene maneuvers. Link at: https://curaseptspa.it/prodotti/curasept-prevent-dentifricio/; Other Names: Curasept Prevent Toothpaste; Drug: Mouthwash Product; Patients have to use the Curasept Prevent Mouthwash daily, during their domiciliar oral hygiene maneuvers. Link at: https://curaseptspa.it/prodotti/curasept-prevent-collutorio/; Other Names: Curasept Prevent Mouthwash

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing Pocket Depth	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).	From enrollment to the end of treatment at 30 days
Full Mouth Plaque Score	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.	From enrollment to the end of treatment at 30 days
Full Mouth Bleeding Score	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.	From enrollment to the end of treatment at 30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Massimo Corsalini

Publications and helpful links

Helpful Links

• Curasept Prevent Mouthwash
• Curasept Prevent Probiotics
• Curasept Prevent Toothpaste

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2023
• Primary Completion (Actual): June 15, 2024
• Study Completion (Actual): July 24, 2024

Study Registration Dates

• First Submitted: April 25, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: probiotics; periodontitis; oral health; ozonated olive oil
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontitis; Periodontal Diseases
• Other Study ID Numbers: Prot. 1983/CEL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD about the arms and their relative outcomes could be shared, respecting the patient's privacy.
• IPD Sharing Time Frame: From today to the next year (25/4/2026)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No