NCT02809313

Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis

Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis: a Randomized Placebo-controlled Trials With 3-month Follow-up

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Jorge Gamonal · Academic / Other
• Sex: All
• Age: 17 Years – 28 Years
• Healthy volunteers: Not accepted

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, n=18) or control (SRP + placebo, n=18) 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.

Conditions

• Gingivitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Treatment Gingivitis with Probiotic	gingivitis treatment (scaling and coronary polish) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months
OTHER	Treatment Gingivitis conventional	gingivitis treatment (scaling and coronary polish) and one sachet containing Placebo (talc powder) per day during 3 months

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-10-01
• Completion: 2016-11-01
• First posted: 2016-06-22
• Last updated: 2016-10-26

Locations

1 site across 1 country: Chile