Status:
COMPLETED
Lactobacillus Reuteri in the Supportive Therapy of Periodontitis
Lead Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Conditions:
Periodontal Diseases
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Literature shows the potential effectiveness of L. reuteri as an adjunct to non-surgical periodontal therapy in initial treatment of periodontitis, but also underlines the limits of the conclusions, a...
Detailed Description
Probiotics are defined as 'live microorganisms which, when administered in adequate amounts, confer a health benefit on the host'. The influence of probiotics on pathogens flora can derive from three ...
Eligibility Criteria
Inclusion
- Signed Informed Consent Form.
- Male and female subjects, aged 18-75 years, inclusive.
- Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives).
- History of periodontitis staging III or IV grading B or C
- At least 2 sites with probing depth ≥6 mm or pockets of 5 mm with bleeding on probing in two different quadrants.
- Previous periodontal non-surgical treatment at least 3 months maximum 6 months.
- Availability for the 6-month duration of the study for an assigned subject.
Exclusion
- Not willing to follow the agreed protocol.
- Presence of orthodontic appliances.
- Smokers (more than 10 cigarettes per day)
- Chronic obstructive pulmonary disease and asthma.
- Tumors or significant pathology of the soft or hard tissues of the oral cavity.
- Current radiotherapy or chemotherapy.
- Pregnant or lactating women.
- Current or past (within 3 months prior to enrolment) administration of medications that may influence periodontal conditions and/or interfere with healing following periodontal treatment (i.e., corticosteroids, calcium channel blockers, systemic antibiotics, ...).
- History of allergy to Erythritol or chlorexidine.
- Restorations on the teeth to be treated which may interfere with treatment administration and/or scoring procedures, at the discretion of the examiner.
- Use of systemically administered antibacterial agents or probiotics 3 months prior to enrollment.
Key Trial Info
Start Date :
October 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04478643
Start Date
October 7 2020
End Date
June 12 2024
Last Update
July 14 2025
Active Locations (1)
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1
Magda Mensi
Brescia, Lombardy, Italy, 25123