Ignite Creation Date:
2024-05-06 @ 8:43 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02809313
Status:
UNKNOWN
Last Update Posted:
2016-10-26
First Post:
2016-06-13
Brief Title:
Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis
Sponsor:
Jorge Gamonal
Organization:
University of Chile
Study Overview
Official Title:
Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis a Randomized Placebo-controlled Trials With 3-month Follow-up
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic sachet as an adjunct to scaling and root planning SRP Material and methods Thirty six gingivitis patients will be recruited and monitored clinically and microbiologically at baseline and 3-6 months after therapy All patients will receive scaling and periodontal treatment and randomly will be assigned over an experimental SRP probiotic n18 or control SRP placebo n18 group The sachet will be used once per day during 3 months
Detailed Description:
Gingivitis is the most prevalent worldwide periodontal disease is characterized by inflammation of the tissues surrounding the tooth without causing periodontal attachment loss Preventive and or therapeutic measures to facilitate or improve their control are therefore very important much more if you consider that gingivitis and periodontitis are considered part of an ongoing inflammatory process Treatment of gingivitis like that of all periodontal diseases has been based on the implementation of control measures personal and professional plaque Notwithstanding the foregoing it has been reported that although mechanical therapy achieved significantly decrease the periodontopathogens this may be only temporary since bacteria can recolonize the treated niches in the oral cavity In this context it has emerged as a new treatment strategy complementary use of probiotics such as Lactobacillus rhamnosus which possess anti-bacterial and anti-inflammatory properties Generally speaking probiotics would promote health by competitive exclusion of some or positive pathogenic bacteria Objective To evaluate the effect of the administration of Lactobacillus rhamnosus as an adjunct to conventional periodontal therapy in adolescent and young adult patients with gingivitis Methodology A randomized double-blind clinical trial to evaluate the effect of sachet probiotic Lactobacillus rhamnosus as an adjunct to conventional periodontal treatment of patients with gingivitis will be performed Expected Results Statistically significant decrease in levels of periodontopathogens P gingivalis A actinomycetemcomitans T forsythia and A viscosus in the experimental group compared with the control Association between clinical and microbiological parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None