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RecruitingNCT07693972Updated Jul 9, 2026

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

An interventional study of Probiotic (L. brevis CD2 lozenges) and Zinc chlorhexidine mouth wash in Halitoses, sponsored by Sara M Almshhadany. Recruiting at 1 site in Iraq. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Sara M Almshhadany · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Dec 2025, registered Jun 2026).
  • Started Dec 2025; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study summary

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?

02

Conditions studied

  • Halitoses

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03

In context

Halitosis

93 studies on the registry are indexed under Halitosis; 17 are open to participants now.

This study's planned enrollment of 60 is above the median of 45 across 79 interventional studies indexed under Halitosis.

Browse Halitosis studies →

Lead sponsor

This is the only study on the registry with Sara M Almshhadany as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. alcohol drinking
  2. smokers, pregnant and lactating womens
  3. allergy or intolerance to treatment, antibiotic, antimicrobial mouth rinses, oral spray or tongue scraper, anti-inflammatory drugs or probiotics.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Other
    halitosis

    halitosis

    Other: Probiotic (L. brevis CD2 lozenges) · Behavioral: Zinc chlorhexidine mouth wash

  • Other
    Plaque accumulation

    1\. Plaque accumulation

    Other: Probiotic (L. brevis CD2 lozenges) · Behavioral: Zinc chlorhexidine mouth wash

Interventions

  • OtherProbiotic (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.

  • BehavioralZinc 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 month

  2. Halitosis

    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

    Time frame: 4 month

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — all data

Supporting information: Statistical analysis plan

Time frame: 2027-2028

Access criteria: researcher

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07693972
Lead sponsor
Sara M Almshhadany
Responsible party
Sara M Almshhadany (assist prof, University of Baghdad) — Sponsor-investigator
First posted
Jul 9, 2026
Start date
Dec 31, 2025
Primary completion
Aug 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Jul 9, 2026

Study contacts

Sara M Almshhadany, assistant professor
Contact
drsara.mshhdany@codental.uobaghdad.edu.iq
006947715860084

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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