Synbiotic as an Adjunct to Mechanical Treatment of Gingivitis

The Effect of Synbiotic Tablet Usage on the Clinical and Biochemical Parameters in Smokers and Nonsmokers With Gingivitis: A Randomized Placebo-Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Gingivitis; Chronic
• Intervention / Treatment: Drug: Placebo Oral Tablet; Drug: Synbiotic Supplement

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 26 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Synbiotic supplements; One synbiotic tablet, per day, during 30 days	Drug: Synbiotic Supplement; Other Names: NOBEL (NBL) Probiotic Optima
Placebo Comparator: Placebo Oral Tablet; One placebo tablet , per day, during 30 days	Drug: Placebo Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	baseline, 1st and 2nd months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline GCF volume at 2 months	Clinical parameter	baseline, 1st and 2nd months
Change from Baseline Gingival Index at 2 months	Clinical parameter	baseline, 1st and 2nd months
Change from Baseline Plaque Index at 2 months	Clinical parameter	baseline, 1st and 2nd months

Collaborators and Investigators

• Sponsor: Kırıkkale University

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2014
• Primary Completion (Actual): June 29, 2015
• Study Completion (Actual): June 29, 2015

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: probiotics; smoking; gingivitis; gingival crevicular fluid; periodontal medicine
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: 2014/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No