Laser Tongue Debridement for Oral Malodor

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.

Study Overview

• Status: Completed
• Conditions: Halitosis
• Intervention / Treatment: Device: Waterlase Express Laser System; Device: Tongue scraper

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • New York Head & Neck Institute offices

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: Tongue scraper; tongue scraping	Device: Tongue scraper; mechanical scraping of the dorso-posterior surface of the tongue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Halimeter measurement	Measurement of volatile sulfur compounds in patient's breath.	change from baseline to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: New York Head & Neck Institute
• Collaborators: Ohio State University; Biolase Inc

Publications and helpful links

General Publications

• Krespi YP, Kizhner V, Wilson KA, Sivriver A, Low S, Khosravi Y, Stoodley P. Laser tongue debridement for oral malodor-A novel approach to halitosis. Am J Otolaryngol. 2021 Jan-Feb;42(1):102458. doi: 10.1016/j.amjoto.2020.102458. Epub 2020 Mar 13.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): October 9, 2019
• Last Update Submitted That Met QC Criteria: October 7, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Halitosis
• Other Study ID Numbers: NY Head and Neck

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes