Probiotic Vs Zinc Chlorhexidine Zn/CHX Mouthwashes in Control Halitosis and Plaque in Fixed Orthodontic Patients

July 6, 2026 updated by: Sara M Almshhadany
This study aims to determine the effect of probiotics and Zn/CHx mouthwashes on plaque accumulation and halitosis in fixed orthodontic patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Do probiotics and Zn/CHx mouthwashes have an effect on plaque accumulation and halitosis in fixed orthodontic patients?

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. good medical health
  2. no systematic disease
  3. non consuming drugs known to influence salivary flow, halitosis, or oral microbiota

Exclusion Criteria:

  1. alcohol drinking
  2. smokers, pregnant and lactating womens
  3. allergy or intolerance to corticosteroid treatment, antibiotic, antimicrobial mouth rinses, oral spray or tongue scraper, anti-inflammatory drugs or probiotics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: halitosis
Other: Probiotic (L. brevis CD2 lozenges)
Probiotic :composed of powerful strain of s.salivarius that preserve innate immune system of the main entry point of the body by taken on a regular basis and establish colonization of the throat and mouth which provide clinical care and support of nose, ear, mouth and throat health and provide fresh breath.
Behavioral: Zinc chlorhexidine mouth wash
Zinc chlorhexidine mouth wash (Zn/CHX) composed of CHX concentrated 0.025% with Zinc acetate 0.3 %, the low concentration of CHX to maintain optimal efficacy with lower incidence of side effects. Zn /CHX was chosen as the active control due to the fact the mixture of Zn salts with low concentration of CHX have shown superior and sustained intra-oral efficacy in managing intra oral halitosis in randomized clinical tria
Other: Plaque accumulation
1. Plaque accumulation
Other: Probiotic (L. brevis CD2 lozenges)
Probiotic :composed of powerful strain of s.salivarius that preserve innate immune system of the main entry point of the body by taken on a regular basis and establish colonization of the throat and mouth which provide clinical care and support of nose, ear, mouth and throat health and provide fresh breath.
Behavioral: Zinc chlorhexidine mouth wash
Zinc chlorhexidine mouth wash (Zn/CHX) composed of CHX concentrated 0.025% with Zinc acetate 0.3 %, the low concentration of CHX to maintain optimal efficacy with lower incidence of side effects. Zn /CHX was chosen as the active control due to the fact the mixture of Zn salts with low concentration of CHX have shown superior and sustained intra-oral efficacy in managing intra oral halitosis in randomized clinical tria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque accumulation
Time Frame: 4 month

plaque build up on bracket surfaces was evaluated by using modified bonded bracket index ( mbb index), Each tooth was divided into four areas (incisal, distal, mesial, gingival). Plaque accumulation was classified into the following assessment grades: grade 0-no plaque, grade 1-plaque covered ≤ 1/3 of the tooth surface, grade 2-plaque covered ≤ 2/3 of the tooth surface, grade 3-plaque covered > 2/3 of the tooth surface. Plaque index (%)= Total of plaque values/ Number of surfaces/ Highest graduation score

× 100.
4 month
Halitosis
Time Frame: 4 month

subjective assessment of halitosis determined by using organoleptic score (OLS) 0 No perceivable odor

  1. Weakly perceivable odor
  2. Perceivable odor
  3. Moderate odor
  4. Strong odor
  5. Extremely strong odor
4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sara M Almshhadany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2025

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 120 (Tumor Vaccine Group)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all data

IPD Sharing Time Frame

2027-2028

IPD Sharing Access Criteria

researcher

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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