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

NCT07693972 | Recruiting DMC

• 1 other identifier: 120
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Halitoses

Outcome Measures

Primary Outcomes (2)

• 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.

  4 month

• 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

  4 month

Study Arms (2)

halitosis

OTHER

halitosis

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

Plaque accumulation

OTHER

1\. Plaque accumulation

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

Interventions

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.

Plaque accumulation; halitosis

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

Plaque accumulation; halitosis

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sara M Almshhadany: lead

Study Sites (1)

College of Dentistry

Baghdad, Alkargh, 10001, Iraq

RECRUITING

Related Links

• Investigation of the inter-rater reliability of three different plaque indices used in patients with fixed orthodontic appliances

MeSH Terms

Conditions

Halitosis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Sara M Almshhadany, assistant professor

CONTACT

006947715860084; drsara.mshhdany@codental.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assist prof

Model Details: randomized double blind parallel groups clinical trial

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 9, 2026
• Study Start: December 31, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 2027-2028
• Access Criteria: researcher

Locations

IR (1)