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

NCT02221193 | Completed Early Phase 1

• 1 other identifier: 0568677142
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (3)

• viable anaerobic and aerobic bacterial counts

  Measuring bacterial numbers by culturing of saliva samples

  one month

• assessment of oral odor

  the mouth odor was assisted by smelling

  one month

• volatile sulfur compounds (VSCs) levels

  these compound measured in part per million

  one month

Study Arms (1)

site specific vs panoral disinfection

EXPERIMENTAL

Other: traditional mouth rinsing and site-specific mouth rinsing (crossover)

Interventions

traditional mouth rinsing and site-specific mouth rinsing (crossover) OTHER

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

site specific vs panoral disinfection

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Al-Baha University: lead

MeSH Terms

Conditions

Halitosis

Interventions

Crossing Over, Genetic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Homologous Recombination; Recombination, Genetic; Genetic Phenomena

Study Design

• Study Type: interventional
• Phase: early phase 1
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 20, 2014
• Study Start: July 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 20, 2014

Record last verified: 2014-08