Comparing Site Specific Mouth Disinfection With Commercial Oral Mouth Rinse With Traditional Oral Maouth Disinfection

Early Phase 1

Completed

• Conditions: Oral Odor (Halitosis); The Study Want to Know if Site Specific Mouth Rinsing With Oral Mouth Disinfectants Can be Better Than Paonoral Mouth Rinsing
• Interventions: Other: traditional mouth rinsing and site-specific mouth rinsing (crossover)

• Registration Number: NCT02221193
• Lead Sponsor: Al-Baha University

Brief Summary

Objectives: To determine whether site-specific mouth rinsing with oral disinfectants can improve oral odor beyond the traditional panoral mouth disinfection with mouth rinses by targeting specifically oral malodor implicate anaerobic bacteria.

Methods: Twenty healthy fasting subjects volunteered for a blinded prospective, descriptive correlational crossover cross-section clinical trial conduct during the month of Ramadan in the lunar Hajri year 1434 AH (10 July 2013-8 August 2013) in Albaha province in Saudi Arabia involving the application of Listerine® Cool Mint® mouth rinse by either the traditional panoral rinsing method or a site-specific disinfection method targeting the subgingival and supragingival plaque and the posterior third of the tongue dorsum while avoiding the remaining locations within the oral cavity. The viable anaerobic and aerobic bacterial counts, volatile sulfur compounds (VSCs) levels, organoleptic assessment of oral odor and the tongue-coating index were compared at baseline, 1, 5 and 9 hours after the treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2013-08
• Study Completion: 2013-09
• Status Verified: 2014-08
• Study First Submitted: 2014-08-18
• Study First Submitted QC: 2014-08-19
• Last Update Submitted: 2014-08-19
• Study First Posted: 2014-08-20
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

1. Saudi Arabia volunteers to be recruited from Albaha province of Saudi Arabia via an online invitation on the e-learning blog www.alqumber.wordpress.com
2. No antibiotic usage and no antiseptic mouth rinse use for the last 3 months and one week preceding the commencement of the study, respectively.
3. Must be dentate healthy Saudi males aged 17-65 years, who adhere to the ritual of fasting.
4. provided informed consent form.

Exclusion Criteria

1. Receiving any professional periodontal treatments (prophylactic scaling, root planning, and periodontal surgery) or professional advice during the previous year. 2. Prior to the inception of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
site specific vs panoral disinfection	traditional mouth rinsing and site-specific mouth rinsing (crossover)	-

Primary Outcome Measures

Name	Time	Method
viable anaerobic and aerobic bacterial counts	one month	Measuring bacterial numbers by culturing of saliva samples
assessment of oral odor	one month	the mouth odor was assisted by smelling
volatile sulfur compounds (VSCs) levels	one month	these compound measured in part per million