CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 108 enrolled
Drug / intervention
Probiotics +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02444182
NCT02444182Phase 2Completed

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

Kuwait University·interventional·Posted May 14, 2015·Updated Mar 14, 2016

In Brief

A Phase 2 clinical trial evaluating Probiotics and Placebo for Periodontal Health and Dental Plaque Accumulation. Completed, enrolled 108 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesKuwait
CollaboratorsUniversity of Turku

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 14, 2015
Enrollment StartDec 1, 2014
Primary CompletionMay 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.1 years ago

Interventions

Probioticsdietary

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

Placebodietary

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