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Laser Tongue Debridement for Oral Malodor

Primary Purpose

Halitosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Waterlase Express Laser System
Tongue scraper
Sponsored by
New York Head & Neck Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Halitosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New York Head & Neck Institute offices

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Waterlase Express Laser System

Tongue scraper

Arm Description

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 scraping

Outcomes

Primary Outcome Measures

Halimeter measurement
Measurement of volatile sulfur compounds in patient's breath.

Secondary Outcome Measures

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.

Full Information

First Posted
September 25, 2019
Last Updated
October 7, 2019
Sponsor
New York Head & Neck Institute
Collaborators
Biolase Inc, Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT04120948
Brief Title
Laser Tongue Debridement for Oral Malodor
Official Title
Laser Tongue Debridement for Oral Malodor
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Head & Neck Institute
Collaborators
Biolase Inc, Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waterlase Express Laser System
Arm Type
Experimental
Arm Description
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.
Arm Title
Tongue scraper
Arm Type
Active Comparator
Arm Description
tongue scraping
Intervention Type
Device
Intervention Name(s)
Waterlase Express Laser System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Tongue scraper
Intervention Description
mechanical scraping of the dorso-posterior surface of the tongue
Primary Outcome Measure Information:
Title
Halimeter measurement
Description
Measurement of volatile sulfur compounds in patient's breath.
Time Frame
change from baseline to 1 month
Secondary Outcome Measure Information:
Title
HALT questionnaire
Description
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.
Time Frame
change from baseline to 1 month
Other Pre-specified Outcome Measures:
Title
bacterial load
Description
Sample is collected from the dorsal tongue surface. Total anaerobic and aerobic bacterial colonies are counted (CFU).
Time Frame
change from baseline to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
New York Head & Neck Institute offices
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33045536
Citation
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.
Results Reference
derived

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Laser Tongue Debridement for Oral Malodor

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