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Effects of Probiotics on Oral Health

Effect of Lactobacillus Rhamnosus LGG and Bifidobacterium Lactis BB-12 on Gingival Health and Dental Plaque in Healthy Adolescents: a Randomized Controlled Clinical Trial

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02444182
Enrollment
108
Registered
2015-05-14
Start date
2014-12-31
Completion date
2015-06-30
Last updated
2016-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Plaque Accumulation, Periodontal Health

Brief summary

Some probiotics have been shown to have preventive effects on infectious diseases and allergies. Because their long-term enhancement of the immune responses of children, they have been recommended for infants in some countries. The most promising ones seem to be the combination of Bifidobacterium lactis BB-12 and Lactobacillus rhamnosus GG. Probiotic microbes are mainly ingested orally and the gastrointestinal tract is thus the primary target organ for them. However, the mouth is the first part of the gastrointestinal tract. Most probiotics are in theory cariogenic, thus their effects on oral health should be known. Several probiotics decrease levels of salivary mutans streptococci (MS), but in other respects very little is known about their effects on the oral microbiota. Also effects of probiotics on dental plaque should be studied. This study aims to find out the effects of the combination of BB-12 and LGG, delivered with a lozenge (4 weeks, twice a day) with a mixture of them on the amount of plaque and gingival health

Detailed description

The Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO) have defined probiotics as live micro-organisms, which when administered in adequate amounts, confer a health benefit to the host (WHO 2002). They should preferably be of human origin, be able to temporarily colonize the gastrointestinal tract and survive in it. They must also be non-pathogenic and non-toxic. Probiotics are used in the prevention and treatment of infectious diseases and allergies (Hatakka and Saxelin, 2008; Salminen et al., 2010). In some countries probiotics are recommended for infants and adults because of their long-term enhancement of the immune responses. Combinations of probiotics, like Bifidobacterium lactis BB-12 (BB-12) and Lactobacillus rhamnosus GG (LGG), appear to be most effective in this respect (Isolauri et al., 2000; Rautava et al., 2009; Smith et al., 2012). Probiotics are mainly ingested orally, and the gastrointestinal tract is thus the primary target organ for probiotic micro-organisms. However, when ingested in the form of for example tablets, chewing gums, cheese and milk, the oral cavity is exposed to the probiotics. With the world-wide increase in the use of probiotics their effects of on oral health have become a hot topic. Many types of probiotic bacteria have been explored but the most widely studied species are those that belong to the genera Lactobacillus and Bifidobacterium. Yogurt and fermented milk products are considered the simplest source of probiotic administration for humans. The proven effects of probiotics in general health has led to more research in the oral health field including dental caries, periodontal disease and halitosis. Some clinical studies have demonstrated a decrease in the cariogenic mutans streptococci counts and in dental plaque (Näse et al. 2001, Ahola et al. 2002, Nikawa et al. 2004, Caglar et al. 2007, Twetman & Keller 2012). Probiotics have also shown improvements in the periodontal status in patients with periodontal disease (Riccia et al. 2007, Shimauchi et al. 2008, Teughels et al. 2013, Yanine et al. 2013). Recently, Toiviainen et al. (2015) found that the combination of Lactobacillus rhamnosus GG (LGG) and Bifidobacterium strain Bifidobacterium lactis (BB-12) improved the periodontal health in healthy adults by reducing the plaque amount and subsequently the gingival inflammation without affecting the oral microbiota. More evidence is necessary to confirm the efficacy of the combination of LGG and BB-12 in the oral health.

Interventions

DIETARY_SUPPLEMENTProbiotics

A half of the participants will be randomly allocated to the probiotics group. They will receive a probiotics lozenge twice a day for 4 weeks. Pre and Post intervention clinical exam will be conducted

DIETARY_SUPPLEMENTPlacebo

A half of the participants will be randomly allocated to the placebo group. Lozenges with no probiotics will be given twice daily for 4 weeks. Pre and Post intervention clinical exam will be conducted

Sponsors

University of Turku
CollaboratorOTHER
Kuwait University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
13 Years to 15 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy Adolescent - ASA I & II * No Antibiotics use * No intake of commercially available probiotics products during the intervention

Exclusion criteria

* Adolescents have ASA III or IV * Antibiotics use * refuse to stop taking commercially available probiotics products during intervention

Design outcomes

Primary

MeasureTime frameDescription
Gingival HealthFour weeksThe gingival Index of Loe and Silness (1963) was used to record all surfaces (buccal, lingual, mesial, distal) for index teeth (16, 12, 24, 36, 32, 44). Gingival pockets were gently touched with a periodontal probe and possible bleeding was registered. The criteria are: 0 = no inflammation 1. = mild inflammation, slight change in color, slight edema, no bleeding on probing 2. = moderate inflammation, moderate glazing, redness, bleeding on probing 3. = severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding The GI of the tooth was determined by adding the scores of the four surfaces and divided the total by four. The GI of the individual was obtained by adding the values of each tooth and dividing by the number of teeth examined A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation, and 2.1-3.0 = severe inflammation
Plaque Indexfour weeksA modified Quickley-Hein plaque index (PI) was used to record the buccal and lingual surfaces of all teeth (from right second molar to left second molar) 0 = no plaque 1. = separate flecks of plaque at the cervical margin of the tooth 2. = a thin continuous band of plaque at the cervical margin 3. = a band of plaque wider than 1 mm but covering less than 1/3 of the crown 4. = plaque covering at least 1/3 but less than 2/3 of the crown 5. = plaque covering 2/3 or more of crown An index for the entire mouth is determined by dividing the total score by the number surfaces (a maximum of 2 x 2 x 14 = 56 surfaces) examined. \*\* Plaque index score reported in the table below represents Pl for the entire mouth. the range is between 0 (no plaque) to 5 (maximum plaque coverage)

Countries

Kuwait

Participant flow

Pre-assignment details

Inclusion criteria of the study: * healthy subject with no history of systemic antibiotics or topical fluoride treatments within the 4 weeks prior to baseline * subject who agrees to suck lozenges containing probiotics twice a day. * subject who agrees to stop taking any other probiotic containing products during the study period

Participants by arm

ArmCount
Probiotics
participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted
54
Control - No Probiotics
Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece) Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted
54
Total108

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up04
Overall Studynon-compliance21

Baseline characteristics

CharacteristicProbioticsControl - No ProbioticsTotal
Age, Continuous14 years
STANDARD_DEVIATION 1
14 years
STANDARD_DEVIATION 1
14 years
STANDARD_DEVIATION 1
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
54 Participants54 Participants108 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Region of Enrollment
Kuwait
54 participants54 participants108 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
54 Participants54 Participants108 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 540 / 54
serious
Total, serious adverse events
0 / 540 / 54

Outcome results

Primary

Gingival Health

The gingival Index of Loe and Silness (1963) was used to record all surfaces (buccal, lingual, mesial, distal) for index teeth (16, 12, 24, 36, 32, 44). Gingival pockets were gently touched with a periodontal probe and possible bleeding was registered. The criteria are: 0 = no inflammation 1. = mild inflammation, slight change in color, slight edema, no bleeding on probing 2. = moderate inflammation, moderate glazing, redness, bleeding on probing 3. = severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding The GI of the tooth was determined by adding the scores of the four surfaces and divided the total by four. The GI of the individual was obtained by adding the values of each tooth and dividing by the number of teeth examined A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation, and 2.1-3.0 = severe inflammation

Time frame: Four weeks

ArmMeasureValue (MEAN)Dispersion
ProbioticsGingival Health0.46 units on a scaleStandard Deviation 0.6
Control - No ProbioticsGingival Health0.18 units on a scaleStandard Deviation 0.39
Comparison: Null hypothesis was no difference in Gingival index between probiotics and control groupsp-value: 0.015paired t-test
Primary

Plaque Index

A modified Quickley-Hein plaque index (PI) was used to record the buccal and lingual surfaces of all teeth (from right second molar to left second molar) 0 = no plaque 1. = separate flecks of plaque at the cervical margin of the tooth 2. = a thin continuous band of plaque at the cervical margin 3. = a band of plaque wider than 1 mm but covering less than 1/3 of the crown 4. = plaque covering at least 1/3 but less than 2/3 of the crown 5. = plaque covering 2/3 or more of crown An index for the entire mouth is determined by dividing the total score by the number surfaces (a maximum of 2 x 2 x 14 = 56 surfaces) examined. \*\* Plaque index score reported in the table below represents Pl for the entire mouth. the range is between 0 (no plaque) to 5 (maximum plaque coverage)

Time frame: four weeks

ArmMeasureValue (MEAN)Dispersion
ProbioticsPlaque Index0.80 units on a scaleStandard Deviation 0.76
Control - No ProbioticsPlaque Index0.71 units on a scaleStandard Deviation 0.67
Comparison: Null hypothesis was no difference in plaque index between probiotics and control groupsp-value: 0.909paired t-test

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026