Synbiotic as an Adjunct to Mechanical Treatment of Gingivitis

NCT ID: NCT03455192

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-22
• Study Completion Date: 2015-06-29

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.

Conditions

Gingivitis; Chronic; Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Synbiotic supplements

One synbiotic tablet, per day, during 30 days

Group Type: EXPERIMENTAL

Synbiotic Supplement

Intervention Type: DRUG

Placebo Oral Tablet

One placebo tablet , per day, during 30 days

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Interventions

Synbiotic Supplement

Intervention Type: DRUG

Placebo Oral Tablet

Intervention Type: DRUG

Other Intervention Names

NOBEL (NBL) Probiotic Optima

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kırıkkale University

OTHER

Sponsor Role: lead

Responsible Party

Nuray Ercan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2014/01

Identifier Type: -

Identifier Source: org_study_id