Gingivitis; Chronic, Smoking
Conditions
Keywords
gingivitis, gingival crevicular fluid, probiotics, smoking, periodontal medicine
Brief summary
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
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.
Interventions
DRUGPlacebo Oral Tablet
Sponsors
Kırıkkale University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
double-blind randomized placebo-controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Interleukin (IL)-6 level of GCF at 2 months | baseline, 1st and 2nd months | GCF samples were collected with paper strips and IL-6 levels of GCF were measured using commercial kits by using ELISA method |
| Change from Baseline IL-8 level of GCF at 2 months | baseline, 1st and 2nd months | GCF samples were collected with paper strips and IL-8 levels of GCF were measured using commercial kits by using ELISA method |
| Change from Baseline IL-10 level of GCF at 2 months | baseline, 1st and 2nd months | GCF samples were collected with paper strips and IL-10 levels of GCF were measured using commercial kits by using ELISA method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline GCF volume at 2 months | baseline, 1st and 2nd months | Clinical parameter |
| Change from Baseline Gingival Index at 2 months | baseline, 1st and 2nd months | Clinical parameter |
| Change from Baseline Plaque Index at 2 months | baseline, 1st and 2nd months | Clinical parameter |
Outcome results
None listed