This trial is active, not recruiting.

Conditions oral flora, gingival health
Treatments probiotics, placebo
Phase phase 1/phase 2
Sponsor Kuwait University
Collaborator University of Turku
Start date April 2015
End date May 2015
Trial size 105 participants
Trial identifier NCT02444182, DD04/13


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, gingival health and microbial composition of plaque and saliva.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
participants will receive a lozenge containing mixture of probiotic bacteria BB-12 and LGG
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
(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)
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

Primary Outcomes

plaque index
time frame: four weeks
Gingival health
time frame: Four weeks

Secondary Outcomes

Changes in the salivary and the plaque microbiota
time frame: four weeks

Eligibility Criteria

Male participants from 13 years up to 15 years old.

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

Additional Information

Official title Effects of Probiotics on the Oral Flora
Principal investigator ABRAR N ALANZI, MS
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. Most clinical studies on probiotics and oral health have focused on measuring changes in counts of Mutans Streptococci (MS) (Stamatova & Meurman, 2009a, Twetman and Keller, 2012). Even though high counts of MS do not necessarily mean an increased caries risk, decreasing MS without affecting the microbiota should make the plaque less virulent.The majority of studies dealing with probiotics and counts of MS have been performed with L. reuteri SD2112 (ATCC 55730), sometimes combined with L. reuteri PTA 5289. Most of them studies showing a decrease of MS counts (Caglar et al., 2007, Stamatova & Meurman, 2009a; Twetman and Keller, 2012), but one had no effect (Marttinen et al., 2012). Some bifidobacteria have been associated in clinical studies with decreases in MS counts (Stamatova & Meurman, 2009a; Twetman and Keller, 2012). LGG was, however, associated with minor (Näse et al., 2001; Ahola et al., 2002) or no changes in MS counts (Marttinen et al., 2012), and L. rhamnosus LB21 with no changes (Stecksen-Blicks et al., 2009). Effects of probiotics on periodontal pathogens has received little interest so far, however, administration of certain probiotics have been associated with improved gingival and periodontal conditions (Teughels, 2011). L. reuteri administration has in one study decreased numbers of selected periodontal pathogens (Iniesta et al., 2012), while a recent study found no effect of L. reuteri on the microbial profile of supragingival plaque (Hallström et al., 2013). One study has addressed L. salivarius WB2, which decreased the numerical sum of five periodontopathogenic bacteria (Mayanagi et al., 2009). In this respect, no information is available on effects of LGG and BB-12.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Kuwait University.