Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis

Gingivitis Clinical Trial

Official title:

Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis: a Randomized Placebo-controlled Trials With 3-month Follow-up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02809313
• Other study ID #: 1130570
• Status: Recruiting
• Phase: Phase 2
• First received: June 13, 2016
• Last updated: October 24, 2016
• Start date: March 2016
• Est. completion date: November 2016

Study information

• Verified date: June 2016
• Source: University of Chile
• Contact: Joel E Bravo Bown, Proffesor
• Phone: +5694540294
• Email: jbravo[@]odontologia.uchile.cl
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 28 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis

Intervention

Dietary Supplement:
• Treatment Gingivitis with Probiotic
gingivitis treatment (scaling and coronary polish) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months

Other:
• Treatment Gingivitis conventional
gingivitis treatment (scaling and coronary polish) and one sachet containing Placebo (talc powder) per day during 3 months

Locations

Country	Name	City	State
Chile	Faculty of Dentistry of University of Chile	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Jorge Gamonal

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences between groups for bleeding on probing changes		baseline, 3 month, 6 month	Yes
Secondary	Differences between groups for gingival index		baseline, 3 month, 6 month	Yes
Secondary	Differences between groups for detection of periodontal pathogens	P. gingivalis, A. actinomicetemcomitans, T. forsythia and A. viscosus	baseline, 3 month, 6 month	Yes
Secondary	Differences between groups for levels of periodontal pathogens changes	P. gingivalis, A. actinomicetemcomitans, T. forsythia and A. viscosus	baseline, 3 month, 6 month	Yes