Laser Tongue Debridement for Oral Malodor

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: October 1, 2018

Interventions

  • 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.
  • Device: Tongue scraper
    • mechanical scraping of the dorso-posterior surface of the tongue

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: Tongue scraper
    • tongue scraping

Clinical Trial Outcome Measures

Primary Measures

  • Halimeter measurement
    • Time Frame: change from baseline to 1 month
    • Measurement of volatile sulfur compounds in patient’s breath.

Secondary Measures

  • HALT questionnaire
    • Time Frame: change from baseline to 1 month
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • New York Head & Neck Institute
  • Collaborator
    • Biolase Inc
  • Provider of Information About this Clinical Study
    • Principal Investigator: victor kizhner, MD – New York Head & Neck Institute

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