Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis

Phase 2

• Conditions: Gingivitis
• Interventions: Dietary Supplement: Treatment Gingivitis with Probiotic; Other: Treatment Gingivitis conventional

• Registration Number: NCT02809313
• Lead Sponsor: Jorge Gamonal

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, 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.

Study Timeline

• Study Start: 2016-03
• Status Verified: 2016-06
• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-22
• Primary Completion: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Diagnosis of Gingivitis
• Gingival index > 1.5 (> 10 % of the sites examined)
• Index increased bleeding on probing 10% of the sites surveyed
• Probing Depth < 3 mm
• Systemically healthy (except for the presence of gingivitis)
• Patients who have not received periodontal treatment and before no intake of medicines such as antibiotics and / or anti-inflammatory in the last 3 months prior to the start of the study

Exclusion Criteria

• Patients who develop systemic disease during the study.
• Patients who have to ingest antibiotics and / or antiinflammatories during the study.
• If you are a woman becomes pregnant during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Gingivitis with Probiotic	Treatment Gingivitis with Probiotic	Gingivitis group of patient treated with conventional therapy (scaling, coronary polish and oral hygiene instruction) and adjunct probiotic containing one sachet Lactobacillus rhamnosus per day during 3 month
Treatment Gingivitis conventional	Treatment Gingivitis conventional	Gingivitis group of patient treated with conventional therapy (scaling, coronary polish and oral hygiene instruction) and adjunct placebo containing one sachet placebo (talc power) per day during 3 month

Primary Outcome Measures

Name	Time	Method
Differences between groups for bleeding on probing changes	baseline, 3 month, 6 month

Secondary Outcome Measures

Name	Time	Method
Differences between groups for detection of periodontal pathogens	baseline, 3 month, 6 month	P. gingivalis, A. actinomicetemcomitans, T. forsythia and A. viscosus
Differences between groups for levels of periodontal pathogens changes	baseline, 3 month, 6 month	P. gingivalis, A. actinomicetemcomitans, T. forsythia and A. viscosus
Differences between groups for gingival index	baseline, 3 month, 6 month

Trial Locations

Locations (1)

Faculty of Dentistry of University of Chile; 🇨🇱 Santiago, Chile