Lactobacillus Reuteri in the Supportive Therapy of Periodontitis

NCT04478643 | Completed Results DMC

• 1 other identifier: PERIOPRO np.: 3965
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Periodontal Diseases

Keywords

Lactobacillus reuteri; Probiotic; Periodontal diseases; GBT

Outcome Measures

Primary Outcomes (1)

• Change in PD (Periodontal Depth)

  Change in mean PD value for each patient measured (from the gingival margin to the bottom of the pocket). Baseline values will be compared to the values recorded in the follow-up visits.

  baseline, 3 and 6 months

Secondary Outcomes (7)

• Risk Progression of the Periodontitis and the Need of Periodontal Surgery

  6 months

• Pocket Closure

  baseline, 3 and 6 months

• Microbiological Changes

  baseline, 3 and 6 months

• Change in REC (Clinical Gingival Recession)

  baseline, 3 and 6 months

• Change in CAL (Clinical Attachment Level)

  baseline, 3 and 6 months

Study Arms (2)

PLACEBO

PLACEBO COMPARATOR

* Collection of microbiological samples from the two deepest sites in two different quadrants. * All patients receive full periodontal charting, full mouth periodontal treatment and OHI (oral hygiene instruction). * Study lozenges without live bacteria are administered to consume at home. The patients are instructed to dissolve the lozenges on their tongue twice a day, preferably after brushing, for 3 weeks.

Dietary Supplement: Placebo

PROBIOTIC (L. Reuteri)

EXPERIMENTAL

* Collection of microbiological samples from the two deepest sites in two different quadrants. * All patients receive full periodontal charting, full mouth periodontal treatment and OHI (oral hygiene instruction). * Study lozenges containing Lactobacillus Reuteri are administered to consume at home. The patients are instructed to dissolve the lozenges on their tongue twice a day, preferably after brushing, for 3 weeks.

Dietary Supplement: Probiotic: Lactobacillus Reuteri

Interventions

Probiotic: Lactobacillus Reuteri DIETARY_SUPPLEMENT

Lactobacillus reuteri ATCC PTA 5289 (a minimum of 2 × 108 colony-forming units L. reuteri Prodentis/lozenge, BioGaia AB)

PROBIOTIC (L. Reuteri)

Placebo DIETARY_SUPPLEMENT

Placebo lozenge. Will be identical in taste, texture and appearance to the Probiotic one.

PLACEBO

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

Magda Mensi

Brescia, Lombardy, 25123, Italy

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Magda Mensi
• Organization: ASST SPEDALI CIVILI - UNIVERSITY OF BRESCIA

magda.mensi@unibs.it

+390303995784

Study Officials

• Magda Mensi

  ASST Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Monocentric, Parallel-Arm, Patient, Statistician, Operator and Examiner are blinded, RCT

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 21, 2020
• Study Start: October 7, 2020
• Primary Completion: February 12, 2024
• Study Completion: June 12, 2024
• Last Updated: July 14, 2025
• Results First Posted: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)