Clinical Effect of Lactobacillus Reuteri in Treatment of Gingivitis

Phase 2

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

• Registration Number: NCT02801773
• Lead Sponsor: University of Chile

Brief Summary

The aim of this randomized placebo- controlled clinical trials is to evaluate the effects of Lactobacillus reuteri containing probiotic lozenges as an adjunct to scaling and root planning (SRP). Material and methods: Thirty six gingivitis patients will be recruited and monitored clinically at baseline, 3 and 6 month 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 lozenges will be used once per day during 3 month.

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 reuteri, 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 reuteri 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 probiotic lozenges Lactobacillus rhamnosus as an adjunct to conventional periodontal treatment of patients with gingivitis will be performed. Expected Results: Statistically significant decrease in bleeding and gingival index in the experimental group compared with the control.

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Primary Completion: 2016-06
• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-06-13
• Study First Posted: 2016-06-16
• Last Update Submitted: 2016-06-18
• Last Update Posted: 2016-06-21
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of Gingivitis
• Gingival index > 1.5 (> 10 % of sites examined)
• Bleeding index > 10 % sites surveyed
• Probing Depth < 4 mm
• Systemically healthy (except for the presence of gingivitis)
• Patients who have not received periodontal treatment before the test and no intake of medicines such antibiotic and/ or anti-inflammatory in the last 3 months prior to the start of the study

Exclusion Criteria

• Patient who develop systemic disease during the study
• Patient who have to ingest antibiotic/ or anti-inflammatories 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 conventional	Treatment Gingivitis conventional	Gingivitis group of patient treated with conventional therapy (scaling, coronary polish and oral higiene instruction) and one lozenge containig placebo (mint lozenge) per day during 3 month
Treatment Gingivitis with Probiotic	Treatment Gingivitis with Probiotic	Gingivitis group of patient treated with conventional therapy (scaling, coronary polish and oral higiene instruction) and adjunct probiotic one lozenge containig Lactobacillus reuteri per day during 3 month

Primary Outcome Measures

Name	Time	Method
Differences between groups for bleeding on probing changes	baseline, 1, 3 month

Secondary Outcome Measures

Name	Time	Method
Differences between groups for gingival index	baseline, 1, 3 month

Trial Locations

Locations (1)

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