Comparing Site Specific Mouth Disinfection With Commercial Oral Mouth Rinse With Traditional Oral Maouth Disinfection
Primary Purpose
Oral Odor (Halitosis), The Study Want to Know if Site Specific Mouth Rinsing With Oral Mouth Disinfectants Can be Better Than Paonoral Mouth Rinsing
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
traditional mouth rinsing and site-specific mouth rinsing (crossover)
Sponsored by
About this trial
This is an interventional supportive care trial for Oral Odor (Halitosis)
Eligibility Criteria
Inclusion Criteria:
- 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
- No antibiotic usage and no antiseptic mouth rinse use for the last 3 months and one week preceding the commencement of the study, respectively.
- Must be dentate healthy Saudi males aged 17-65 years, who adhere to the ritual of fasting.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
site specific vs panoral disinfection
Arm Description
Outcomes
Primary Outcome Measures
viable anaerobic and aerobic bacterial counts
Measuring bacterial numbers by culturing of saliva samples
assessment of oral odor
the mouth odor was assisted by smelling
volatile sulfur compounds (VSCs) levels
these compound measured in part per million
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02221193
Brief Title
Comparing Site Specific Mouth Disinfection With Commercial Oral Mouth Rinse With Traditional Oral Maouth Disinfection
Official Title
Site-Specific Mouth Rinsing to Improve Oral Odor by Altering Bacterial Counts: Blind Crossover Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Baha University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Odor (Halitosis), The Study Want to Know if Site Specific Mouth Rinsing With Oral Mouth Disinfectants Can be Better Than Paonoral Mouth Rinsing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
site specific vs panoral disinfection
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
traditional mouth rinsing and site-specific mouth rinsing (crossover)
Intervention Description
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 Measure Information:
Title
viable anaerobic and aerobic bacterial counts
Description
Measuring bacterial numbers by culturing of saliva samples
Time Frame
one month
Title
assessment of oral odor
Description
the mouth odor was assisted by smelling
Time Frame
one month
Title
volatile sulfur compounds (VSCs) levels
Description
these compound measured in part per million
Time Frame
one month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
No antibiotic usage and no antiseptic mouth rinse use for the last 3 months and one week preceding the commencement of the study, respectively.
Must be dentate healthy Saudi males aged 17-65 years, who adhere to the ritual of fasting.
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.
12. IPD Sharing Statement
Learn more about this trial
Comparing Site Specific Mouth Disinfection With Commercial Oral Mouth Rinse With Traditional Oral Maouth Disinfection
We'll reach out to this number within 24 hrs