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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Group B: effective toothpaste and mouthwash. Placebo probiotics | Experimental | The patients of this group received effective toothpaste and mouthwash. Probiotics tablets were placebo. |
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| Group C: effective toothpaste, mouthwash and probiotics. | Experimental | The patients of this group received effective toothpaste, mouthwash and probiotics. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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/ |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari | Bari | BA | 70124 | Italy |
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| Label | URL |
|---|---|
| Curasept Prevent Mouthwash | View source |
| Curasept Prevent Toothpaste | View source |
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IPD about the arms and their relative outcomes could be shared, respecting the patient's privacy.
From today to the next year (25/4/2026)
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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3 parallel arms interventional study model
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| 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/ |
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| Probiotic | Dietary Supplement | Patients received a daily tablet of Curasept Prevent Probiotics. Link at: https://curaseptspa.it/prodotti/curasept-prevent-probiotico-integratore-alimentare/ |
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| 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. |
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| D019602 |
| Food and Beverages |