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NCT Number: NCT07693972

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

This study aims to determine the effect of probiotics and Zn/CHx mouthwashes on plaque accumulation and halitosis in fixed orthodontic patients.

Recruiting

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Dentistry

Baghdad, Alkargh, 10001, Iraq

Location status: Recruiting

Location contact

Sara M Almshhadany

CONTACT

[email protected]

006947715860084

Sara M Almshhadany, assist

PRINCIPAL_INVESTIGATOR

sara almashhadany, assist prof

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • good medical health
  • no systematic disease
  • non consuming drugs known to influence salivary flow, halitosis, or oral microbiota

Exclusion criteria

  • 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.

Treatment and study plan

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 wash

Behavioral

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

Primary outcomes

  1. 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.

  2. Halitosis

    Time frame: 4 month

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Sara M Almshhadany, assistant professor

CONTACT

[email protected]

006947715860084

Sponsors and collaborators

Lead sponsor

Sara M Almshhadany

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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