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| Name | Class |
|---|---|
| University of Turku | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Experimental | participants will receive a lozenge containing mixture of probiotic bacteria BB-12 and LGG |
|
| Control - No probiotics | Placebo Comparator | Participants will receive a control lozenge containing no probiotics. all lozenges are sugar-free; sweetened by xylitol (0.5 g xylitol per piece) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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
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 | Four weeks |
| 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
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) | four weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABRAR N ALANZI, MS | KUWAIT UNIVERISTY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abdullah Alwaheeb intermediate School | Kuwait City | Kuwait | 13110 | Kuwait |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14121956 | Result | LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available. |
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Inclusion criteria of the study:
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Sample size determination was based on the data by Toiviainen et al. (2015). A sample size of 104 subjects (92 + 10% to provide cover in case of subject drop out) was predicted to provide 80% power with an α of 0.05.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | school children in 7-9th grades (aged 13-15 years) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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
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 | Posted | Mean | Standard Deviation | units on a scale | Four weeks |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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limitations of this study include:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Abrar Alanzi | Kuwait University - Faculty of Dentistry | 24636812 | aalanzi@hsc.edu.kw |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | 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 |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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
| OG001 | 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 |
|
|
|
| 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
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) | Posted | Mean | Standard Deviation | units on a scale | four weeks |
|
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | 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 | 0 | 54 | 0 | 54 |
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| D019602 |
| Food and Beverages |