Clinical Effect of Lactobacillus Reuteri in Treatment of Gingivitis

NCT ID: NCT02801773

Last Updated: 2016-06-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-12-31

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.

Conditions

Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Treatment Gingivitis with Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Gingivitis Treatment (scaling and coronary polish) and one lozenge containing Lactobacillus reuteri per day during 3 months

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

Group Type: PLACEBO_COMPARATOR

Treatment Gingivitis conventional

Intervention Type: OTHER

gingivis treatment (scaling and coronary polish) and and one lozenge containing Placebo (mint lozenge) per day during 3 months

Interventions

Treatment Gingivitis with Probiotic

Gingivitis Treatment (scaling and coronary polish) and one lozenge containing Lactobacillus reuteri per day during 3 months

Intervention Type: DIETARY_SUPPLEMENT

Treatment Gingivitis conventional

gingivis treatment (scaling and coronary polish) and and one lozenge containing Placebo (mint lozenge) per day during 3 months

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 28 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Jorge Gamonal

Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jorge Gamonal Aravena, Proffesor

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry of University of Chile

Locations

Faculty of Dentistry of University of Chile

Santiago, Santiago Metropolitan, Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Joel E Bravo Bown, Proffesor

Role: CONTACT

jbravo@odontologia.uchile.cl

+5694540294

Facility Contacts

Jorge A Gamonal Aravena, Profesor

Role: primary

+56229781839

Other Identifiers

1130570-Fondecyt

Identifier Type: -

Identifier Source: org_study_id