Skip to main content
OpenTrials
Completed

NCT Number: NCT04120948

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Halitosis Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Head & Neck Institute offices

New York, 10019, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Waterlase Express Laser System

Device

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

Device

mechanical scraping of the dorso-posterior surface of the tongue

Primary outcomes

  1. Halimeter measurement

    Time frame: change from baseline to 1 month

    Measurement of volatile sulfur compounds in patient's breath.

Secondary outcomes

  1. 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.

Other outcomes

  1. bacterial load

    Time frame: change from baseline to 1 month

    Sample is collected from the dorsal tongue surface. Total anaerobic and aerobic bacterial colonies are counted (CFU).

Sponsors and collaborators

Lead sponsor

New York Head & Neck Institute

Other

Collaborators

  • Biolase Inc
  • Ohio State University

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 9, 2019
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.