Laser Tongue Debridement for Oral Malodor

Halitosis Clinical Trial

Official title:

Laser Tongue Debridement for Oral Malodor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04120948
• Other study ID #: NY Head and Neck
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: October 2019
• Source: New York Head & Neck Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Malodor is a multifactorial condition with oral pathology representing the main culprit and the tongue being the first to second contributor to the malodor. Bacterial load can represent a quantifiable measure regardless of the original pathology. It is hypothesized that reduction in malodor can be represented by tongue changes both in appearance, bacterial and biofilm load reduction (measured by CFU and volatile gases measurement), organoleptic measurement and subjective improvement.

Methods: A randomized controlled prospective study under IRB approval. Diagnostic criteria for enrollment and follow up were organoleptic test by 2 judges, halimeter reading, tongue colores changes HALT questionnaire and direct aerobic and anaerobic tongue cultures measured by CFU. Patients were treated with laser tongue debridement (LTD) with an Er,Cr:YSGG solid state laser has been shown to be effective in biofilm reduction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• an individual (male or female) who can understand and voluntarily sign an informed consent form

• a baseline organoleptic oral malodor score of at least 2

Exclusion Criteria:

• severe caries,

• signs of gingival inflammation on intraoral exam

• possible extra-oral halitosis (tonsillitis, sinusitis, and pulmonary pathologic conditions, or a condition that may contribute to systemic halitosis, such as hepatic cirrhosis or uncontrolled diabetes)

• antibiotic treatment within 1 month prior to study

• pregnant

Related Conditions & MeSH terms

• Halitosis

Intervention

Device:
• Waterlase Express Laser System
10-minute treatment with the Waterlase Express (Biolase, Irvine CA). The dorso-posterior surface of the tongue is treated with the laser in 10 passes of 60 seconds each with 10 seconds of rest in between. Laser settings were 60µs pulse width, 4W, 40Hz, 10% air and 5% water irrigation. An MC12 sapphire laser tip (Biolase, Irvine CA) is held 3mm away from the tongue in a constant sweeping motion during treatment with passes overlapping passes in alternate direction, side to side motion and front to back motion with laser fluence on the tongue surface calculated at 3J/cm2. The settings were non ablative and non thermal.
• Tongue scraper
mechanical scraping of the dorso-posterior surface of the tongue

Locations

Country	Name	City	State
United States	New York Head & Neck Institute offices	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York Head & Neck Institute	Biolase Inc, Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	bacterial load	Sample is collected from the dorsal tongue surface. Total anaerobic and aerobic bacterial colonies are counted (CFU).	change from baseline to 1 month
Primary	Halimeter measurement	Measurement of volatile sulfur compounds in patient's breath.	change from baseline to 1 month
Secondary	HALT questionnaire	Quality of life (QOL) questionnaire that ranks responses. The total score is evaluated on a scale of 0-100. A score of 0 correlates to no perceived effect on QOL, and a score of 100 correlates to a severe perceived effect on QOL.	change from baseline to 1 month