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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Gingivitis with Probiotic | Experimental | 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 |
|
| Treatment Gingivitis conventional | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment Gingivitis with Probiotic | Dietary Supplement | gingivitis treatment (scaling and coronary polish) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Differences between groups for bleeding on probing changes | baseline, 3 month, 6 month |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joel E Bravo Bown, Proffesor | Contact | +5694540294 | jbravo@odontologia.uchile.cl |
| Name | Affiliation | Role |
|---|---|---|
| Jorge Gamonal Aravena, Proffesor | Faculty of Dentistry of University of Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry of University of Chile | Recruiting | Santiago | Santiago Metropolitan | Chile |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Treatment Gingivitis conventional | Other | gingivitis treatment (scaling and coronary polish) and one sachet containing Placebo (talc powder) per day during 3 months |
|
| 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 |
| D009057 |
| Stomatognathic Diseases |
| D019602 |
| Food and Beverages |