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

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.

Study Overview

• Status: Unknown
• Conditions: Gingivitis
• Intervention / Treatment: Dietary supplement: Treatment Gingivitis with Probiotic; Other: Treatment Gingivitis conventional

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Joel E Bravo Bown, Proffesor; Phone Number: +5694540294; Email: jbravo@odontologia.uchile.cl

Study Locations

• Chile
  • Santiago, Chile
    • Recruiting
    • Faculty of Dentistry of University of Chile
    • Contact: Jorge A Gamonal, Profesor; Phone Number: +56229781839
    • Sub-Investigator: Joel E Bravo Bown, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 28 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: Treatment Gingivitis with Probiotic; gingivitis treatment (scaling and coronary polish) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months
Placebo Comparator: 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	Other: Treatment Gingivitis conventional; gingivitis treatment (scaling and coronary polish) and one sachet containing Placebo (talc powder) per day during 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Differences between groups for bleeding on probing changes	baseline, 3 month, 6 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jorge Gamonal
• Investigators: Principal Investigator: Jorge Gamonal Aravena, Proffesor, Faculty of Dentistry of University of Chile

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: June 13, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (Estimate): June 22, 2016

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: probiotic; gingivitis; non- surgical treatment
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: 1130570

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO