Lactobacillus Reuteri in the Supportive Therapy of Periodontitis

Launched by AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA · Jul 15, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the potential benefits of a probiotic called Lactobacillus reuteri in helping patients with severe forms of gum disease, known as periodontitis. The goal is to see if adding this probiotic to standard gum treatment can improve patients' gum health and reduce the number of infected pockets in the gums. Participants will be divided into two groups: one will receive the probiotic lozenges, while the other will receive a placebo (a lozenge with no active ingredients). Both lozenges will look and taste the same, and participants will take them twice a day for three weeks.

To be eligible for the trial, participants should be aged 18 to 75 and have a specific diagnosis of periodontitis with certain characteristics, like deeper gum pockets. They should be in good general health and not have conditions that could interfere with the study, such as diabetes or cancer. Participants will need to be available for follow-ups over six months to assess their gum health and the effectiveness of the treatment. This trial is currently recruiting participants, and it aims to provide valuable insights into how probiotics might support gum health in people with severe periodontitis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.