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Effects of Probiotics on Oral Health

Primary Purpose

Periodontal Health, Dental Plaque Accumulation

Status
Completed
Phase
Phase 1
Locations
Kuwait
Study Type
Interventional
Intervention
Probiotics
Placebo
Sponsored by
Kuwait University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Periodontal Health

Eligibility Criteria

13 Years - 15 Years (Child)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Abdullah Alwaheeb intermediate School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotics

Control - No probiotics

Arm Description

participants will receive a lozenge containing mixture of probiotic bacteria BB-12 and LGG

Participants will receive a control lozenge containing no probiotics. all lozenges are sugar-free; sweetened by xylitol (0.5 g xylitol per piece)

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

Full Information

First Posted
May 12, 2015
Last Updated
February 16, 2016
Sponsor
Kuwait University
Collaborators
University of Turku
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1. Study Identification

Unique Protocol Identification Number
NCT02444182
Brief Title
Effects of Probiotics on Oral Health
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuwait University
Collaborators
University of Turku

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Health, Dental Plaque Accumulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotics
Arm Type
Experimental
Arm Description
participants will receive a lozenge containing mixture of probiotic bacteria BB-12 and LGG
Arm Title
Control - No probiotics
Arm Type
Placebo Comparator
Arm Description
Participants will receive a control lozenge containing no probiotics. all lozenges are sugar-free; sweetened by xylitol (0.5 g xylitol per piece)
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Gingival Health
Description
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
Time Frame
Four weeks
Title
Plaque Index
Description
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)
Time Frame
four weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABRAR N ALANZI, MS
Organizational Affiliation
KUWAIT UNIVERISTY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abdullah Alwaheeb intermediate School
City
Kuwait
ZIP/Postal Code
13110
Country
Kuwait

12. IPD Sharing Statement

Citations:
PubMed Identifier
14121956
Citation
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.
Results Reference
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Effects of Probiotics on Oral Health

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