Periodontal DiseaseNCT06955546
Probiotics And Ozonated Olive Oil To Maintain Oral Eubiosis In Stage I And II Periodontitis Patients
A study testing Toothpaste Product, Mouthwash Product and Probiotic in people with Periodontal Disease and Periodontal Disease Stage 2, run by Massimo Corsalini at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Periodontal Disease Stage 2
- What is being tested?
- Toothpaste Product, Mouthwash Product and Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2023to 24 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, BA, 70124
About this study
Official title: Probiotics And Ozonated Olive Oil To Maintain Oral Eubiosis In Stage I And II Periodontitis Patients: A Randomized, Triple-Blind Clinical Trial
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.
Read more
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
- Being tested
- Toothpaste Product, Mouthwash Product, Probiotic, Placebo
- Keywords
- periodontitis, probiotics, oral health, ozonated olive oil
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste ProductDrug
Also called Curasept Prevent Toothpaste
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 ProductDrug
Also called Curasept Prevent Mouthwash
Patients have to use the Curasept Prevent Mouthwash daily, during their domiciliar oral hygiene maneuvers.
Link at: https://curaseptspa.it/prodotti/curasept-prevent-collutorio/
ProbioticDietary supplement
Also called Curasept Prevent Probiotic
Patients received a daily tablet of Curasept Prevent Probiotics. Link at: https://curaseptspa.it/prodotti/curasept-prevent-probiotico-integratore-alimentare/
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Placebo |
| Group B: effective toothpaste and mouthwash. Placebo probiotics | Experimental | The patients of this group received effective toothpaste and mouthwash. Probiotics tablets were placebo. Receives: Drug: Toothpaste Product; Drug: Mouthwash Product |
| Group C: effective toothpaste, mouthwash and probiotics. | Experimental | The patients of this group received effective toothpaste, mouthwash and probiotics. Receives: Drug: Toothpaste Product; Drug: Mouthwash Product; Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 30 days
Secondary outcomes (1)
Adherence
The quality of adherence to the prescribed therapies was verified at each visit interval. Adherence was assessed as "valid" or "invalid."
Measured: From enrollment to the end of treatment at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start7 Jan 2023
- Primary completion15 Jun 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 parallel arms interventional study model
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massimo Corsalini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Massimo Corsalini, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955546
- Sponsor's protocol ID
- Prot. 1983/CEL
- Status last verified
- May 2025
- First submitted
- 25 Apr 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD about the arms and their relative outcomes could be shared, respecting the patient's privacy.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics And Ozonated Olive Oil To Maintain Oral Eubiosis In Stage I And II Periodontitis Patients: A Randomized, Triple-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06955546
- Acronym / sponsor ID
- Prot. 1983/CEL
- Conditions
- Periodontal Disease, Periodontal Disease Stage 2
- Keywords
- periodontitis, probiotics, oral health, ozonated olive oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Massimo CorsaliniUniversity, hospital or other
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 parallel arms interventional study model
| Arm | Type | Receives |
|---|---|---|
| Group A: Placebo Group | Placebo comparator | Other: PlaceboIn 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. |
| Group B: effective toothpaste and mouthwash. Placebo probiotics | Experimental | Drug: Toothpaste Product, Drug: Mouthwash ProductThe patients of this group received effective toothpaste and mouthwash. Probiotics tablets were placebo. |
| Group C: effective toothpaste, mouthwash and probiotics. | Experimental | Drug: Toothpaste Product, Drug: Mouthwash Product, Dietary Supplement: ProbioticThe patients of this group received effective toothpaste, mouthwash and probiotics. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toothpaste ProductAlso: Curasept Prevent ToothpastePatients have to use the Curasept Prevent Toothpaste daily, during their domiciliar oral hygiene maneuvers. Link at: https://curaseptspa.it/prodotti/curasept-prevent-dentifricio/ | Drug | Group B: effective toothpaste and mouthwash. Placebo probiotics, Group C: effective toothpaste, mouthwash and probiotics. |
| Mouthwash ProductAlso: Curasept Prevent MouthwashPatients have to use the Curasept Prevent Mouthwash daily, during their domiciliar oral hygiene maneuvers. Link at: https://curaseptspa.it/prodotti/curasept-prevent-collutorio/ | Drug | Group B: effective toothpaste and mouthwash. Placebo probiotics, Group C: effective toothpaste, mouthwash and probiotics. |
| ProbioticAlso: Curasept Prevent ProbioticPatients received a daily tablet of Curasept Prevent Probiotics. Link at: https://curaseptspa.it/prodotti/curasept-prevent-probiotico-integratore-alimentare/ | Dietary supplement | Group C: effective toothpaste, mouthwash and probiotics. |
| PlaceboPatients 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 | Group A: Placebo Group |
Primary outcome
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).
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.
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.
1 secondary outcome
Adherence
Time frame: From enrollment to the end of treatment at 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Curasept Prevent MouthwashLink provided by the sponsor.
- Curasept Prevent ToothpasteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD about the arms and their relative outcomes could be shared, respecting the patient's privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothpaste Product, Mouthwash Product and Probiotic in people with Periodontal Disease and Periodontal Disease Stage 2, run by Massimo Corsalini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Pocket Depth (time frame: From enrollment to the end of treatment at 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.