An interventional study of Synbiotic Supplement and Placebo Oral Tablet in Gingivitis; Chronic and Smoking, sponsored by Kırıkkale University. Completed. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-06.
Sponsored by Kırıkkale University · Not applicable, Interventional, and Treatment
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.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's enrollment of 80 is above the median of 66 across 507 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Kırıkkale University is the lead sponsor of 114 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
One synbiotic tablet, per day, during 30 days
Drug: Synbiotic Supplement
One placebo tablet , per day, during 30 days
Drug: Placebo Oral Tablet
Also known as: NOBEL (NBL) Probiotic Optima
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
Time frame: 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
Time frame: 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
Time frame: baseline, 1st and 2nd months
Change from Baseline GCF volume at 2 months
Clinical parameter
Time frame: baseline, 1st and 2nd months
Change from Baseline Gingival Index at 2 months
Clinical parameter
Time frame: baseline, 1st and 2nd months
Change from Baseline Plaque Index at 2 months
Clinical parameter
Time frame: baseline, 1st and 2nd months
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.).
Supporting information: Study protocol, Clinical study report
Time frame: study protocol : at the beginning of the study (july 2014) Clinical Study Report (CSR): july 2014, january 2015, july 2015, january 2016, april 2016
Access criteria: study protocol : with all researchers Clinical Study Report (CSR): Interviewed with all researchers by face to face
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Synbiotic Supplement