Probiotics And Ozonated Olive Oil To Maintain Oral Eubiosis In Stage I And II Periodontitis Patients
NCT ID: NCT06955546
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2023-01-07
2024-07-24
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
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.
Group B: effective toothpaste and mouthwash. Placebo probiotics
The patients of this group received effective toothpaste and mouthwash. Probiotics tablets were placebo.
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/
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/
Group C: effective toothpaste, mouthwash and probiotics.
The patients of this group received effective toothpaste, mouthwash and probiotics.
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/
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/
Probiotic
Patients received a daily tablet of Curasept Prevent Probiotics. Link at: https://curaseptspa.it/prodotti/curasept-prevent-probiotico-integratore-alimentare/
Interventions
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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/
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/
Probiotic
Patients received a daily tablet of Curasept Prevent Probiotics. Link at: https://curaseptspa.it/prodotti/curasept-prevent-probiotico-integratore-alimentare/
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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Massimo Corsalini
OTHER
Responsible Party
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Massimo Corsalini
Associate Professor
Locations
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Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, BA, Italy
Countries
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Related Links
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Curasept Prevent Mouthwash
Curasept Prevent Probiotics
Curasept Prevent Toothpaste
Other Identifiers
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Prot. 1983/CEL
Identifier Type: -
Identifier Source: org_study_id
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