N/A
N=44
Lactobacillus Reuteri in the Supportive Therapy of Periodontitis
Periodontal Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04478643 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Change in PD (Periodontal Depth) — 5.63; 5.45; 4.01; 4.03 millimeter
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Probiotic: Lactobacillus Reuteri (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PD (Periodontal Depth) |
5.63; 5.45; 4.01; 4.03; 3.92; 3.97 | — |
| SECONDARY Risk Progression of the Periodontitis and the Need of Periodontal Surgery |
— | — |
| SECONDARY Pocket Closure |
10.7; 9.6; 4.8; 5.9; 5.2; 5.5 | — |
| SECONDARY Microbiological Changes |
— | — |
| SECONDARY Change in REC (Clinical Gingival Recession) |
0.45; 0.51; 0.62; 0.54; 0.76; 0.48 | — |
| SECONDARY Change in CAL (Clinical Attachment Level) |
5.92; 5.79; 4.28; 4.41; 4.17; 4.41 | — |
| SECONDARY Change in BOP (Bleeding on Probing) |
89.0; 83.5; 50.9; 49.7; 38.8; 42.3 | — |
| SECONDARY Change in PI (Plaque Index) |
52.1; 38.6; 32.4; 31.4; 26.8; 33.6 | — |
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, and the heterogeneity and limited sample size of the available studies. Therefore, there is a need for longer-term, randomized, controlled studies. Moreover, only one study addresses the use of this probiotic during the supportive therapy, in particular in patients with severe forms of periodontitis, and only few patients were included.
Patients meeting the criteria of periodontitis stage III and IV, grade C are considered to be affected by severe and advanced forms of periodontitis with a rapid rate of progression. This group of patients could particularly benefit from supplements for the maintenance of periodontal health.
The hypothesis of the present randomized controlled trial is that the adjunctive use of probiotic treatment can bring clinical and microbiological advantages during the supportive therapy of periodontal disease, and reduce the number of residual pockets.
To test this hypothesis, the patients, upon initial evaluation, will be divided in 2 study groups and, after a session of professional oral hygiene, will be prescribed one of the therapies below:
* PLACEBO: The patients of the control group will receive control lozenges without live bacteria;
* TEST: The patients of the probiotic group will receive probiotic lozenges containing Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 (a minimum of 2 × 108 colony-forming units L. reuteri Prodentis/lozenge, BioGaia AB).
The probiotic and control lozenges will be identical in taste, texture and appearance. The lozenges will be given to all patients to consume at home. The patients will be instructed to dissolve them on their tongue twice a day, preferably after brushing, for 3 weeks.
Periodontal and microbiological parameters will be evaluated at 3 and 6 months after the initial therapy, and compared between the two groups.
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.
Data sourced from ClinicalTrials.gov (NCT04478643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.