Synbiotic as an Adjunct to Mechanical Treatment of Gingivitis
Primary Purpose
Gingivitis; Chronic, Smoking
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Synbiotic Supplement
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis; Chronic focused on measuring gingivitis, gingival crevicular fluid, probiotics, smoking, periodontal medicine
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Synbiotic supplements
Placebo Oral Tablet
Arm Description
One synbiotic tablet, per day, during 30 days
One placebo tablet , per day, during 30 days
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
Change from Baseline GCF volume at 2 months
Clinical parameter
Change from Baseline Gingival Index at 2 months
Clinical parameter
Change from Baseline Plaque Index at 2 months
Clinical parameter
Full Information
NCT ID
NCT03455192
First Posted
February 16, 2018
Last Updated
February 27, 2018
Sponsor
Kırıkkale University
1. Study Identification
Unique Protocol Identification Number
NCT03455192
Brief Title
Synbiotic as an Adjunct to Mechanical Treatment of Gingivitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 22, 2014 (Actual)
Primary Completion Date
June 29, 2015 (Actual)
Study Completion Date
June 29, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırıkkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis; Chronic, Smoking
Keywords
gingivitis, gingival crevicular fluid, probiotics, smoking, periodontal medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
double-blind randomized placebo-controlled clinical trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Synbiotic supplements
Arm Type
Experimental
Arm Description
One synbiotic tablet, per day, during 30 days
Arm Title
Placebo Oral Tablet
Arm Type
Placebo Comparator
Arm Description
One placebo tablet , per day, during 30 days
Intervention Type
Drug
Intervention Name(s)
Synbiotic Supplement
Other Intervention Name(s)
NOBEL (NBL) Probiotic Optima
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Primary Outcome Measure Information:
Title
Change from Baseline Interleukin (IL)-6 level of GCF at 2 months
Description
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
Title
Change from Baseline IL-8 level of GCF at 2 months
Description
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
Title
Change from Baseline IL-10 level of GCF at 2 months
Description
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
Secondary Outcome Measure Information:
Title
Change from Baseline GCF volume at 2 months
Description
Clinical parameter
Time Frame
baseline, 1st and 2nd months
Title
Change from Baseline Gingival Index at 2 months
Description
Clinical parameter
Time Frame
baseline, 1st and 2nd months
Title
Change from Baseline Plaque Index at 2 months
Description
Clinical parameter
Time Frame
baseline, 1st and 2nd months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.).
IPD Sharing 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
IPD Sharing Access Criteria
study protocol : with all researchers Clinical Study Report (CSR): Interviewed with all researchers by face to face
Learn more about this trial
Synbiotic as an Adjunct to Mechanical Treatment of Gingivitis
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