Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-26 @ 2:45 AM
Study NCT ID:
NCT03455192
Status:
COMPLETED
Last Update Posted:
2018-03-06
First Post:
2018-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synbiotic as an Adjunct to Mechanical Treatment of Gingivitis
Sponsor:
Kırıkkale University
Organization:
Study Overview
Official Title:
The Effect of Synbiotic Tablet Usage on the Clinical and Biochemical Parameters in Smokers and Nonsmokers With Gingivitis: A Randomized Placebo-Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: