The Effect of Probiotics on Gums Health and Bad Breath

NCT ID: NCT06910397

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-03

Study Completion Date

2025-06-01

Brief Summary

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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

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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

Conditions

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Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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probiotic group

each participant will take one tablet of probiotic daily for 28 days

Group Type ACTIVE_COMPARATOR

Probiotic Arm

Intervention Type DRUG

one tablet daily for 28 days

placebo group-

each participant will take one tablet of placebo tablet daily for 28 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

placebo tablet once daily for 28 days

Interventions

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Probiotic Arm

one tablet daily for 28 days

Intervention Type DRUG

Placebo

placebo tablet once daily for 28 days

Intervention Type OTHER

Eligibility Criteria

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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).

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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Mustansiriyah University

OTHER

Sponsor Role lead

Responsible Party

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BAYDAA ABDULQAHAR YOUNUS

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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BAYDAA Y Alani, MSc student

Role: PRINCIPAL_INVESTIGATOR

Locations

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AL- Mustansiriyah University College of Dentistry

Baghdad, , Iraq

Site Status

Countries

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Iraq

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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MUPRV13

Identifier Type: -

Identifier Source: org_study_id

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