Synbiotic as an Adjunct to Mechanical Treatment of Gingivitis

Kırıkkale University

Status: Completed

Conditions: Gingivitis; Chronic; Smoking

Treatments: Drug: Placebo Oral Tablet; Drug: Synbiotic Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT03455192

2014/01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Synbiotic supplements

Experimental group

Description:

One synbiotic tablet, per day, during 30 days

Treatment:

Drug: Synbiotic Supplement

Placebo Oral Tablet

Placebo Comparator group

Description:

One placebo tablet , per day, during 30 days

Treatment:

Drug: Placebo Oral Tablet