Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02221193
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Dr Mohammed Abdullah Alqumber, 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.


Condition or disease Intervention/treatment Phase
Oral Odor (Halitosis) The Study Want to Know if Site Specific Mouth Rinsing With Oral Mouth Disinfectants Can be Better Than Paonoral Mouth Rinsing Other: traditional mouth rinsing and site-specific mouth rinsing (crossover) Early Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Site-Specific Mouth Rinsing to Improve Oral Odor by Altering Bacterial Counts: Blind Crossover Clinical Study
Study Start Date : July 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: site specific vs panoral disinfection Other: traditional mouth rinsing and site-specific mouth rinsing (crossover)
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




Primary Outcome Measures :
  1. viable anaerobic and aerobic bacterial counts [ Time Frame: one month ]
    Measuring bacterial numbers by culturing of saliva samples

  2. assessment of oral odor [ Time Frame: one month ]
    the mouth odor was assisted by smelling

  3. volatile sulfur compounds (VSCs) levels [ Time Frame: one month ]
    these compound measured in part per million



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   17 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Layout table for additonal information
Responsible Party: Dr Mohammed Abdullah Alqumber, Assistant Professor, Al-Baha University
ClinicalTrials.gov Identifier: NCT02221193    
Other Study ID Numbers: 0568677142
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Halitosis
Signs and Symptoms, Digestive