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Completed

NCT Number: NCT06955546

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

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.

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Key information

Conditions

Periodontal Disease Mouth Diseases Periodontal Disease Stage 2 Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, BA, 70124, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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/

Other names: Curasept Prevent Toothpaste

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/

Other names: Curasept Prevent Mouthwash

Probiotic

Dietary Supplement

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

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.

Primary outcomes

  1. Probing Pocket Depth

    Time frame: 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).

  2. Full Mouth Plaque Score

    Time frame: 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.

  3. Full Mouth Bleeding Score

    Time frame: 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.

Secondary outcomes

  1. Adherence

    Time frame: 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."

Sponsors and collaborators

Lead sponsor

Massimo Corsalini

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 2, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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