Phase 2
N=108
Effects of Probiotics on Oral Health
Periodontal Health · Dental Plaque Accumulation
Bottom Line
View on ClinicalTrials.gov: NCT02444182 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Gingival Health — 0.46; 0.18 units on a scale — p=0.015
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Probiotics (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Pediatric · 13+ yrs
- Sex
- Male
- Sponsor
- Kuwait University
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gingival Health |
0.46; 0.18 | 0.015 sig |
| PRIMARY Plaque Index |
0.80; 0.71 | 0.909 |
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
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
Data sourced from ClinicalTrials.gov (NCT02444182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.