Periodontal Disease, Periodontal Disease Stage 2
Conditions
Keywords
periodontitis, probiotics, oral health, ozonated olive oil
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.
Interventions
Patients have to use the Curasept Prevent Toothpaste daily, during their domiciliar oral hygiene maneuvers. Link at: https://curaseptspa.it/prodotti/curasept-prevent-dentifricio/
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_SUPPLEMENTProbiotic
Patients received a daily tablet of Curasept Prevent Probiotics. Link at: https://curaseptspa.it/prodotti/curasept-prevent-probiotico-integratore-alimentare/
OTHERPlacebo
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
Massimo Corsalini
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
3 parallel arms interventional study model
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing Pocket Depth | 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). |
| Full Mouth Plaque Score | 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. |
| Full Mouth Bleeding Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 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. |
Countries
Italy
Outcome results
None listed