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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synbiotic supplements | Experimental | One synbiotic tablet, per day, during 30 days |
|
| Placebo Oral Tablet | Placebo Comparator | One placebo tablet , per day, during 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synbiotic Supplement | Drug |
|
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Randomization was performed by one researcher that had never any role in participant's treatment and clinical measurement processes (E.O.E). Patients' all measurements and treatments were made by a single researcher who doesn't know in which group participants were included (N.E.).
study protocol : at the beginning of the study (july 2014) Clinical Study Report (CSR): july 2014, january 2015, july 2015, january 2016, april 2016
study protocol : with all researchers Clinical Study Report (CSR): Interviewed with all researchers by face to face
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 27, 2018 | Feb 27, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 27, 2018 | Feb 27, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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double-blind randomized placebo-controlled clinical trial
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| Placebo Oral Tablet |
| Drug |
|
| baseline, 1st and 2nd months |
| Change from Baseline Plaque Index at 2 months | Clinical parameter | baseline, 1st and 2nd months |
| D009057 |
| Stomatognathic Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D001519 | Behavior |