Synbiotic as an Adjunct to Mechanical Treatment of Gingivitis

Study Overview
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Brief Summary
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The aim of this study is to evaluate the efficacy of oral administration of synbiotic tablets on the clinical parameters and the levels of selected inflammatory mediators in gingival crevicular fluid (GCF) in smokers and non-smokers with gingivitis. This study designed as a double-blind randomized placebo-controlled clinical trial.

Detailed Description
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Some patients like smokers have ongoing host response even after bacterial plaque removal achieved. Therefore efforts to develop effective treatment approaches remain an important objective in the treatment of gingivitis to prevent periodontitis especially in patients at high risk for developing periodontitis as smokers. Smoking is a major risk factor for the incidence and the progression of periodontal diseases. The increased periodontal disease susceptibility in smokers is predominantly caused by changes in inflammatory and immune responses. Cigarette smoking also influences the amount and the composition of subgingival plaque. Smokers have higher numbers of pathogens in their resident biofilm and display an ongoing host response even after biofilm removal. Different approaches were explored to reduce the negative effects of smoking on the outcomes of periodontal therapy Synbiotic were defined as a mixture of probiotics and prebiotics that beneficially affects the host by improving the survival and implantation of live microbial dietary supplements in the gastrointestinal tract, by selectively stimulating the growth and/or by activating the metabolism of one or a limited number of health-promoting bacteria, and thus improving host welfare. Also in some cases, this may lead to a competitive advantage for the probiotics among with other bacteria.

Official Title
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The Effect of Synbiotic Tablet Usage on the Clinical and Biochemical Parameters in Smokers and Nonsmokers With Gingivitis: A Randomized Placebo-Controlled Clinical Trial

Conditions
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Gingivitis; Chronic, Smoking

Intervention / Treatment
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* Drug: Synbiotic Supplement
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy subjects Clinical diagnosis of gingivitis Exclusion Criteria: Subjects who had used any systemic antibiotics in the previous 3 months, Subjects who had used a product containing probiotics in the previous month Systemic disease or condition that could interfere with the study results Ongoing drug therapy that could affect the signs of gingivitis Subjects who were received periodontal treatment in the last 6 months and Allergic to milk and milk products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: double-blind randomized placebo-controlled clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synbiotic supplements<br>One synbiotic tablet, per day, during 30 days | Drug: Synbiotic Supplement<br> <br> * Other names: NOBEL (NBL) Probiotic Optima;|
| Placebo Comparator: Placebo Oral Tablet<br>One placebo tablet , per day, during 30 days | Drug: Placebo Oral Tablet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Interleukin (IL)-6 level of GCF at 2 months | GCF samples were collected with paper strips and IL-6 levels of GCF were measured using commercial kits by using ELISA method | baseline, 1st and 2nd months | 
| Change from Baseline IL-8 level of GCF at 2 months | GCF samples were collected with paper strips and IL-8 levels of GCF were measured using commercial kits by using ELISA method | baseline, 1st and 2nd months | 
| Change from Baseline IL-10 level of GCF at 2 months | GCF samples were collected with paper strips and IL-10 levels of GCF were measured using commercial kits by using ELISA method | baseline, 1st and 2nd months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline GCF volume at 2 months | Clinical parameter | baseline, 1st and 2nd months | 
| Change from Baseline Gingival Index at 2 months | Clinical parameter | baseline, 1st and 2nd months | 
| Change from Baseline Plaque Index at 2 months | Clinical parameter | baseline, 1st and 2nd months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gingivitis, gingival crevicular fluid, probiotics, smoking, periodontal medicine