Trial Outcomes & Findings for Lactobacillus Reuteri in the Supportive Therapy of Periodontitis (NCT NCT04478643)
NCT ID: NCT04478643
Last Updated: 2025-07-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
baseline, 3 and 6 months
Results posted on
2025-07-14
Participant Flow
Participant milestones
| Measure |
PLACEBO
* 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.
Placebo: Placebo lozenge. Will be identical in taste, texture and appearance to the Probiotic one.
|
PROBIOTIC (L. Reuteri)
* 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.
Probiotic: Lactobacillus Reuteri: Lactobacillus reuteri ATCC PTA 5289 (a minimum of 2 × 108 colony-forming units L. reuteri Prodentis/lozenge, BioGaia AB)
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lactobacillus Reuteri in the Supportive Therapy of Periodontitis
Baseline characteristics by cohort
| Measure |
PLACEBO
n=20 Participants
* 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.
Placebo: Placebo lozenge. Will be identical in taste, texture and appearance to the Probiotic one.
|
PROBIOTIC (L. Reuteri)
n=20 Participants
* 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.
Probiotic: Lactobacillus Reuteri: Lactobacillus reuteri ATCC PTA 5289 (a minimum of 2 × 108 colony-forming units L. reuteri Prodentis/lozenge, BioGaia AB)
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
51.418 years
STANDARD_DEVIATION 7.765 • n=5 Participants
|
51.961 years
STANDARD_DEVIATION 12.627 • n=7 Participants
|
51.689 years
STANDARD_DEVIATION 10.343 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 and 6 monthsChange 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.
Outcome measures
| Measure |
PLACEBO
n=20 Participants
* 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.
Placebo: Placebo lozenge. Will be identical in taste, texture and appearance to the Probiotic one.
|
PROBIOTIC (L. Reuteri)
n=20 Participants
* 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.
Probiotic: Lactobacillus Reuteri: Lactobacillus reuteri ATCC PTA 5289 (a minimum of 2 × 108 colony-forming units L. reuteri Prodentis/lozenge, BioGaia AB)
|
|---|---|---|
|
Change in PD (Periodontal Depth)
BASELINE
|
5.63 millimeter
Interval 5.24 to 6.05
|
5.45 millimeter
Interval 5.06 to 5.86
|
|
Change in PD (Periodontal Depth)
3 MONTHS
|
4.01 millimeter
Interval 3.73 to 4.32
|
4.03 millimeter
Interval 3.75 to 4.33
|
|
Change in PD (Periodontal Depth)
6 MONTHS
|
3.92 millimeter
Interval 3.65 to 4.22
|
3.97 millimeter
Interval 3.69 to 4.27
|
SECONDARY outcome
Timeframe: 6 monthsChange in percentage of patient who need periodontal surgery. Periodontal stability is defined as \< 10% of sites bleeding on probing, no probing depths of 4 mm or greater that bleed on probing, and lack of progressive periodontal destruction. Baseline values will be compared to the values recorded in the follow-up visits.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 3 and 6 monthsChange in percentage of site \> 4mm. Baseline values will be compared to the values recorded in the follow-up visits.
Outcome measures
| Measure |
PLACEBO
n=20 Participants
* 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.
Placebo: Placebo lozenge. Will be identical in taste, texture and appearance to the Probiotic one.
|
PROBIOTIC (L. Reuteri)
n=20 Participants
* 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.
Probiotic: Lactobacillus Reuteri: Lactobacillus reuteri ATCC PTA 5289 (a minimum of 2 × 108 colony-forming units L. reuteri Prodentis/lozenge, BioGaia AB)
|
|---|---|---|
|
Pocket Closure
BASELINE
|
10.7 percentage
Interval 7.0 to 16.6
|
9.6 percentage
Interval 6.2 to 14.8
|
|
Pocket Closure
3 MONTHS
|
4.8 percentage
Interval 3.0 to 7.5
|
5.9 percentage
Interval 3.8 to 9.2
|
|
Pocket Closure
6 MONTHS
|
5.2 percentage
Interval 3.3 to 8.1
|
5.5 percentage
Interval 3.6 to 8.7
|
SECONDARY outcome
Timeframe: baseline, 3 and 6 monthschanges in microbial composition (kind of bacteria) and proportion (% of pathogen) of sequences identified as Lactobacillus reuteri in the deepest residual pockets
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 3 and 6 monthsChange in mean of REC value for each patient should be calculated. Baseline values will be compared to the values recorded in the follow-up visits.
Outcome measures
| Measure |
PLACEBO
n=20 Participants
* 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.
Placebo: Placebo lozenge. Will be identical in taste, texture and appearance to the Probiotic one.
|
PROBIOTIC (L. Reuteri)
n=20 Participants
* 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.
Probiotic: Lactobacillus Reuteri: Lactobacillus reuteri ATCC PTA 5289 (a minimum of 2 × 108 colony-forming units L. reuteri Prodentis/lozenge, BioGaia AB)
|
|---|---|---|
|
Change in REC (Clinical Gingival Recession)
6 MONTHS
|
0.76 millimeter
Interval 0.31 to 1.91
|
0.48 millimeter
Interval 0.2 to 1.2
|
|
Change in REC (Clinical Gingival Recession)
BASELINE
|
0.45 millimeter
Interval 0.18 to 1.12
|
0.51 millimeter
Interval 0.21 to 1.27
|
|
Change in REC (Clinical Gingival Recession)
3 MONTHS
|
0.62 millimeter
Interval 0.25 to 1.55
|
0.54 millimeter
Interval 0.22 to 1.34
|
SECONDARY outcome
Timeframe: baseline, 3 and 6 monthsChange in mean of CAL value for each patient should be calculated. Baseline values will be compared to the values recorded in the follow-up visits.
Outcome measures
| Measure |
PLACEBO
n=20 Participants
* 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.
Placebo: Placebo lozenge. Will be identical in taste, texture and appearance to the Probiotic one.
|
PROBIOTIC (L. Reuteri)
n=20 Participants
* 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.
Probiotic: Lactobacillus Reuteri: Lactobacillus reuteri ATCC PTA 5289 (a minimum of 2 × 108 colony-forming units L. reuteri Prodentis/lozenge, BioGaia AB)
|
|---|---|---|
|
Change in CAL (Clinical Attachment Level)
BASELINE
|
5.92 millimeter
Interval 5.45 to 6.44
|
5.79 millimeter
Interval 5.32 to 6.31
|
|
Change in CAL (Clinical Attachment Level)
6 MONTHS
|
4.17 millimeter
Interval 3.83 to 4.54
|
4.41 millimeter
Interval 4.05 to 4.8
|
|
Change in CAL (Clinical Attachment Level)
3 MONTHS
|
4.28 millimeter
Interval 3.93 to 4.66
|
4.41 millimeter
Interval 4.05 to 4.8
|
SECONDARY outcome
Timeframe: baseline, 3 and 6 monthsChange in percentage of sites positive to bleeding on probing. Baseline values will be compared to the values recorded in the follow-up visits.
Outcome measures
| Measure |
PLACEBO
n=20 Participants
* 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.
Placebo: Placebo lozenge. Will be identical in taste, texture and appearance to the Probiotic one.
|
PROBIOTIC (L. Reuteri)
n=20 Participants
* 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.
Probiotic: Lactobacillus Reuteri: Lactobacillus reuteri ATCC PTA 5289 (a minimum of 2 × 108 colony-forming units L. reuteri Prodentis/lozenge, BioGaia AB)
|
|---|---|---|
|
Change in BOP (Bleeding on Probing)
BASELINE
|
89.0 percentage
Interval 83.3 to 93.0
|
83.5 percentage
Interval 76.2 to 88.9
|
|
Change in BOP (Bleeding on Probing)
3 MONTHS
|
50.9 percentage
Interval 40.3 to 61.3
|
49.7 percentage
Interval 39.5 to 60.0
|
|
Change in BOP (Bleeding on Probing)
6 MONTHS
|
38.8 percentage
Interval 29.2 to 49.3
|
42.3 percentage
Interval 32.6 to 52.8
|
SECONDARY outcome
Timeframe: baseline, 3 and 6 monthsChange in percentage of site with plaque. Baseline values will be compared to the values recorded in the follow-up visits.
Outcome measures
| Measure |
PLACEBO
n=20 Participants
* 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.
Placebo: Placebo lozenge. Will be identical in taste, texture and appearance to the Probiotic one.
|
PROBIOTIC (L. Reuteri)
n=20 Participants
* 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.
Probiotic: Lactobacillus Reuteri: Lactobacillus reuteri ATCC PTA 5289 (a minimum of 2 × 108 colony-forming units L. reuteri Prodentis/lozenge, BioGaia AB)
|
|---|---|---|
|
Change in PI (Plaque Index)
3 MONTHS
|
32.4 percentage
Interval 18.6 to 46.3
|
31.4 percentage
Interval 19.3 to 43.6
|
|
Change in PI (Plaque Index)
6 MONTHS
|
26.8 percentage
Interval 14.0 to 39.6
|
33.6 percentage
Interval 21.3 to 45.9
|
|
Change in PI (Plaque Index)
BASELINE
|
52.1 percentage
Interval 40.2 to 63.9
|
38.6 percentage
Interval 25.5 to 51.7
|
Adverse Events
PLACEBO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PROBIOTIC (L. Reuteri)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Magda Mensi
ASST SPEDALI CIVILI - UNIVERSITY OF BRESCIA
Phone: +390303995784
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place