Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis

NCT ID: NCT02809313

Last Updated: 2016-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-11-30

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.

Conditions

Gingivitis

Keywords

gingivitis; probiotic; non- surgical treatment

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 hygiene instruction) and adjunct probiotic containing one sachet Lactobacillus rhamnosus per day during 3 month

Group Type: EXPERIMENTAL

Treatment Gingivitis with Probiotic

Intervention Type: DIETARY_SUPPLEMENT

gingivitis treatment (scaling and coronary polish) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months

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

Group Type: PLACEBO_COMPARATOR

Treatment Gingivitis conventional

Intervention Type: OTHER

gingivitis treatment (scaling and coronary polish) and one sachet containing Placebo (talc powder) per day during 3 months

Interventions

Treatment Gingivitis with Probiotic

gingivitis treatment (scaling and coronary polish) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months

Intervention Type: DIETARY_SUPPLEMENT

Treatment Gingivitis conventional

gingivitis treatment (scaling and coronary polish) and one sachet containing Placebo (talc powder) per day during 3 months

Intervention Type: OTHER

Eligibility Criteria

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.

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

Sponsors

Jorge Gamonal

OTHER

Sponsor Role: lead

Responsible Party

Jorge Gamonal

Professor

Responsibility Role: SPONSOR_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

Phone: +5694540294

Email: jbravo@odontologia.uchile.cl

Facility Contacts

Jorge A Gamonal, Profesor

Role: primary

Other Identifiers

1130570

Identifier Type: -

Identifier Source: org_study_id