Effects of Probiotics on Oral Health

Periodontal Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444182
• Other study ID #: DD04/13
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 12, 2015
• Last updated: February 16, 2016
• Start date: December 2014
• Est. completion date: June 2015

Study information

• Verified date: February 2016
• Source: Kuwait University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kuwait: Joint Committee for the Protection of Human Subjects in Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 13 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Plaque
• Dental Plaque Accumulation
• Periodontal Health

Intervention

Dietary Supplement:
• Probiotics
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
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

Locations

Country	Name	City	State
Kuwait	Abdullah Alwaheeb intermediate School	Kuwait

Sponsors (2)

Lead Sponsor	Collaborator
Kuwait University	University of Turku

Country where clinical trial is conducted

Kuwait, 

References & Publications (1)

LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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; = mild inflammation, slight change in color, slight edema, no bleeding on probing; = moderate inflammation, moderate glazing, redness, bleeding on probing; = 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	Four weeks	No
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; = separate flecks of plaque at the cervical margin of the tooth; = a thin continuous band of plaque at the cervical margin; = a band of plaque wider than 1 mm but covering less than 1/3 of the crown; = plaque covering at least 1/3 but less than 2/3 of the crown; = 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)	four weeks	No