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Laser Tongue Debridement for Oral Malodor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04120948
Recruitment Status : Completed
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Collaborators:
Biolase Inc
Ohio State University
Information provided by (Responsible Party):
victor kizhner, New York Head & Neck Institute

Brief 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.


Condition or disease Intervention/treatment Phase
Halitosis Device: Waterlase Express Laser System Device: Tongue scraper Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Laser Tongue Debridement for Oral Malodor
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bad Breath

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




Primary Outcome Measures :
  1. Halimeter measurement [ Time Frame: change from baseline to 1 month ]
    Measurement of volatile sulfur compounds in patient's breath.


Secondary Outcome Measures :
  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 Outcome Measures:
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120948


Locations
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United States, New York
New York Head & Neck Institute offices
New York, New York, United States, 10019
Sponsors and Collaborators
New York Head & Neck Institute
Biolase Inc
Ohio State University

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Responsible Party: victor kizhner, MD, New York Head & Neck Institute
ClinicalTrials.gov Identifier: NCT04120948    
Other Study ID Numbers: NY Head and Neck
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Halitosis
Signs and Symptoms, Digestive
Signs and Symptoms