Synbiotic as an Adjunct to Mechanical Treatment of Gingivitis

NCT03455192 | Completed

• 1 other identifier: 2014/01
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingivitis; Chronic; Smoking

Keywords

gingivitis; gingival crevicular fluid; probiotics; smoking; periodontal medicine

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change from Baseline GCF volume at 2 months

  baseline, 1st and 2nd months

• Change from Baseline Gingival Index at 2 months

  baseline, 1st and 2nd months

• Change from Baseline Plaque Index at 2 months

  baseline, 1st and 2nd months

Study Arms (2)

Synbiotic supplements

EXPERIMENTAL

One synbiotic tablet, per day, during 30 days

Drug: Synbiotic Supplement

Placebo Oral Tablet

PLACEBO COMPARATOR

One placebo tablet , per day, during 30 days

Drug: Placebo Oral Tablet

Interventions

Synbiotic Supplement DRUG

Also known as: NOBEL (NBL) Probiotic Optima

Synbiotic supplements

Placebo Oral Tablet DRUG

Placebo Oral Tablet

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy subjects
• Clinical diagnosis of gingivitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Kırıkkale University: lead

MeSH Terms

Conditions

Gingivitis; Bronchiolitis Obliterans Syndrome; Smoking

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: double-blind randomized placebo-controlled clinical trial

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: March 6, 2018
• Study Start: July 22, 2014
• Primary Completion: June 29, 2015
• Study Completion: June 29, 2015
• Last Updated: March 6, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• 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
• Access Criteria: study protocol : with all researchers Clinical Study Report (CSR): Interviewed with all researchers by face to face