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

NCT06955546 | Completed DMC

• 1 other identifier: Prot. 1983/CEL
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Disease; Periodontal Disease Stage 2

Keywords

periodontitis; probiotics; oral health; ozonated olive oil

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Adherence

  From enrollment to the end of treatment at 30 days

Study Arms (3)

Group A: Placebo Group

PLACEBO COMPARATOR

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

Group B: effective toothpaste and mouthwash. Placebo probiotics

EXPERIMENTAL

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

Drug: Toothpaste Product; Drug: Mouthwash Product

Group C: effective toothpaste, mouthwash and probiotics.

EXPERIMENTAL

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

Drug: Toothpaste Product; Drug: Mouthwash Product; Dietary Supplement: Probiotic

Interventions

Toothpaste Product DRUG

Patients have to use the Curasept Prevent Toothpaste daily, during their domiciliar oral hygiene maneuvers. Link at: https://curaseptspa.it/prodotti/curasept-prevent-dentifricio/

Also known as: Curasept Prevent Toothpaste

Group B: effective toothpaste and mouthwash. Placebo probiotics; Group C: effective toothpaste, mouthwash and probiotics.

Mouthwash Product DRUG

Patients have to use the Curasept Prevent Mouthwash daily, during their domiciliar oral hygiene maneuvers. Link at: https://curaseptspa.it/prodotti/curasept-prevent-collutorio/

Also known as: Curasept Prevent Mouthwash

Group B: effective toothpaste and mouthwash. Placebo probiotics; Group C: effective toothpaste, mouthwash and probiotics.

Probiotic DIETARY_SUPPLEMENT

Patients received a daily tablet of Curasept Prevent Probiotics. Link at: https://curaseptspa.it/prodotti/curasept-prevent-probiotico-integratore-alimentare/

Also known as: Curasept Prevent Probiotic

Group C: effective toothpaste, mouthwash and probiotics.

Placebo OTHER

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 A: Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massimo Corsalini: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, BA, 70124, Italy

Location

Related Links

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

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 3 parallel arms interventional study model

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 2, 2025
• Study Start: January 7, 2023
• Primary Completion: June 15, 2024
• Study Completion: July 24, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From today to the next year (25/4/2026)

Locations

IT (1)