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OpenTrials
Completed

NCT Number: NCT03455192

Synbiotic as an Adjunct to Mechanical Treatment of Gingivitis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synbiotic Supplement

Drug

Other names: NOBEL (NBL) Probiotic Optima

Placebo oral tablet

Drug

Primary outcomes

  1. Change from Baseline Interleukin (IL)-6 level of GCF at 2 months

    Time frame: 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

  2. Change from Baseline IL-8 level of GCF at 2 months

    Time frame: 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

  3. Change from Baseline IL-10 level of GCF at 2 months

    Time frame: 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 outcomes

  1. Change from Baseline GCF volume at 2 months

    Time frame: baseline, 1st and 2nd months

    Clinical parameter

  2. Change from Baseline Gingival Index at 2 months

    Time frame: baseline, 1st and 2nd months

    Clinical parameter

  3. Change from Baseline Plaque Index at 2 months

    Time frame: baseline, 1st and 2nd months

    Clinical parameter

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 6, 2018
Registry last updated
Mar 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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