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The Effect of Probiotics on Gums Health and Bad Breath

A

Al-Mustansiriyah University

Status

Not yet enrolling

Conditions

Gingivitis

Treatments

Other: Placebo
Drug: Probiotic Arm

Study type

Interventional

Funder types

Other

Identifiers

NCT06910397
MUPRV13

Details and patient eligibility

About

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

Full 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

Enrollment

90 estimated patients

Sex

All

Ages

17 to 25 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 2 patient groups, including a placebo group

probiotic group
Active Comparator group
Description:
each participant will take one tablet of probiotic daily for 28 days
Treatment:
Drug: Probiotic Arm
placebo group-
Placebo Comparator group
Description:
each participant will take one tablet of placebo tablet daily for 28 days
Treatment:
Other: Placebo

Trial documents
1

Trial contacts and locations

0

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Central trial contact

MOHAMMED I ALZUBIDI, SUPERVISOR

Data sourced from clinicaltrials.gov

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