Gingivitis
Conditions
Keywords
probiotics and gingival health
Brief summary
the study is about using healthy bacteria to improve the overall gingival and overall health and prevent or decrease the bad odor of the mouth caused by bad bacteria
Detailed description
The goal of this study is to verify the effect of Probiotics on oral Health Status and eliminate the gingival disease and Halitosis by measuring the levels of salivary biomarkers (cytokine IL-1b and proteases Matrix metalloproteinase (MMP-8) in saliva) and level of volatile sulfur compounds (VSCs) and their effects on improving gingival diseases clinical parameters in person age of (17-25) years old. The participants are randomly divided into two parallel groups (A, B). Group A will take probiotics and group B will take placebo for 28 days. The levels of IL-1b, MMP-8 in saliva, and VSCs measurement will be recorded respectively in different intervals of zero time and repeated on 14 days and 28 days. Statistical analysis will be done then comparative between two groups
Interventions
DRUGProbiotic Arm
one tablet daily for 28 days
OTHERPlacebo
placebo tablet once daily for 28 days
Sponsors
Al-Mustansiriyah University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
The Inclusion criteria * Subjects (male and female) between the age range 17-25 years old. * Subjects with mouth breathing habit. * Subjects with orthodontic and prosthodontic appliance * Race from Iraq. * Subjects having a dentition with ≥20 evaluable teeth (minimum of five teeth per quadrant). The
Exclusion criteria
* History of chronic disease. * History of systemic disease. * Patients with autoimmune diseases. * Patients under antibiotic treatment. * Pregnant, lactating females. * History of undergoing nonsurgical and surgical periodontal therapy in the last 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| oral health measures for 90 participant of both group | four weeks(0day,14 day,28 day) | gingival index (scale 0-3),plaque index (scale 0-3), oral health index- simplex is composed of the Debris index and Calculus index (scoring six tooth segments in the mouth for each participants in both groups for the study and control group. |
| Halitosis (90 participant of both group) | four weeks(0 day,14 day, 28 day) | Measuring the level of volatile sulfur compounds (VSCs) by use heliometer device (YRY Smart Breath Odor Detector), calculate social distance on (cm unite), detailed odor concentration on(ppm unite), and the related light color on the display screen for each participants in both groups the study and control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The salivary biomarkers (90 participant of both group) | four weeks (0 day,14 day ,28 day) | Pro-inflammatory cytokine IL-1B (pg/ml). Matrix metalloproteinase neutrophil collagenase MMP-8 (pg/ml) for each participants in both groups the study and control group. |
Countries
Iraq
Outcome results
None listed