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

NCT06955546 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-05-31

No results posted yet for this study

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

Interventions

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/

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/

DIETARY_SUPPLEMENT

Probiotic

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

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.

Sponsors & Collaborators

  • Massimo Corsalini

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-07
Primary Completion
2024-06-15
Completion
2024-07-24

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06955546 on ClinicalTrials.gov