HalitosesNCT07693972
Probiotic Vs Zinc Chlorhexidine Zn/CHX Mouthwashes in Control Halitosis and Plaque in Fixed Orthodontic Patients
A study testing Probiotic (L. brevis CD2 lozenges) and Zinc chlorhexidine mouth wash in people with Halitoses, run by Sara M Almshhadany at 1 site in Iraq.
Trial summary
This study aims to determine the effect of probiotics and Zn/CHx mouthwashes on plaque accumulation and halitosis in fixed orthodontic patients. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Halitoses
- What is being tested?
- Probiotic (L. brevis CD2 lozenges) and Zinc chlorhexidine mouth wash
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 31 Dec 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good medical health
- no systematic disease
- non consuming drugs known to influence salivary flow, halitosis, or oral microbiota
Who cannot join
- alcohol drinking
- smokers, pregnant and lactating womens
- allergy or intolerance to corticosteroid treatment, antibiotic, antimicrobial mouth rinses, oral spray or tongue scraper, anti-inflammatory drugs or probiotics.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sara M Almshhadany, assistant professor contact
Iraq1 site, 1 recruiting
- Recruiting
College of Dentistry
Baghdad, Alkargh, 10001
Sara M Almshhadany, 006947715860084, drsara.mshhdany@codental.uobaghdad.edu.iq
sara almashhadany, assist prof, drsara.mshhdany@codental.uobaghdad.edu.iq
About this study
This study aims to determine the effect of probiotics and Zn/CHx mouthwashes on plaque accumulation and halitosis in fixed orthodontic patients.
Read the detailed description
Do probiotics and Zn/CHx mouthwashes have an effect on plaque accumulation and halitosis in fixed orthodontic patients?
- Conditions
- Halitoses
- Being tested
- Probiotic (L. brevis CD2 lozenges), Zinc chlorhexidine mouth wash
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic (L. brevis CD2 lozenges)Other
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.
Zinc chlorhexidine mouth washBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| halitosis | Other | halitosis Receives: Other: Probiotic (L. brevis CD2 lozenges); Behavioral: Zinc chlorhexidine mouth wash |
| Plaque accumulation | Other | 1. Plaque accumulation Receives: Other: Probiotic (L. brevis CD2 lozenges); Behavioral: Zinc chlorhexidine mouth wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque accumulation
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.
Measured: 4 month
Halitosis
subjective assessment of halitosis determined by using organoleptic score (OLS) 0 No perceivable odor
- Weakly perceivable odor
- Perceivable odor
- Moderate odor
- Strong odor
- Extremely strong odor
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start31 Dec 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HalitosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- randomized double blind parallel groups clinical trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sara M Almshhadany
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara M Almshhadany, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693972
- Sponsor's protocol ID
- 120
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Vs Zinc Chlorhexidine Zn/CHX Mouthwashes in Control Halitosis and Plaque in Fixed Orthodontic Patients
- ClinicalTrials.gov ID
- NCT07693972
- Acronym / sponsor ID
- 120
- Conditions
- Halitoses
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sara M AlmshhadanyUniversity, hospital or other
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the effect of probiotics and Zn/CHx mouthwashes on plaque accumulation and halitosis in fixed orthodontic patients.
Detailed description
Do probiotics and Zn/CHx mouthwashes have an effect on plaque accumulation and halitosis in fixed orthodontic patients?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized double blind parallel groups clinical trial
| Arm | Type | Receives |
|---|---|---|
| halitosis | Other | Other: Probiotic (L. brevis CD2 lozenges), Behavioral: Zinc chlorhexidine mouth washhalitosis |
| Plaque accumulation | Other | Other: Probiotic (L. brevis CD2 lozenges), Behavioral: Zinc chlorhexidine mouth wash1. Plaque accumulation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- good medical health
- no systematic disease
- non consuming drugs known to influence salivary flow, halitosis, or oral microbiota
Key exclusion criteria (3 listed)
- alcohol drinking
- smokers, pregnant and lactating womens
- allergy or intolerance to corticosteroid treatment, antibiotic, antimicrobial mouth rinses, oral spray or tongue scraper, anti-inflammatory drugs or probiotics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Plaque accumulation, halitosis |
| Zinc chlorhexidine mouth washZinc 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 | Behavioural | Plaque accumulation, halitosis |
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Investigation of the inter-rater reliability of three different plaque indices used in patients with fixed orthodontic appliancesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara M Almshhadany, assistant professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic (L. brevis CD2 lozenges) and Zinc chlorhexidine mouth wash in people with Halitoses, run by Sara M Almshhadany at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara M Almshhadany, assistant professor (006947715860084, drsara.mshhdany@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque accumulation (time frame: 4 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.