Laser Tongue Debridement for Oral Malodor

NCT04120948 | Completed FDA Device

• 1 other identifier: NY Head and Neck
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Halitosis

Outcome Measures

Primary Outcomes (1)

• Halimeter measurement

  Measurement of volatile sulfur compounds in patient's breath.

  change from baseline to 1 month

Secondary Outcomes (1)

• HALT questionnaire

  change from baseline to 1 month

Other Outcomes (1)

• bacterial load

  change from baseline to 1 month

Study Arms (2)

Waterlase Express Laser System

EXPERIMENTAL

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

Tongue scraper

ACTIVE COMPARATOR

tongue scraping

Device: Tongue scraper

Interventions

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.

Waterlase Express Laser System

Tongue scraper DEVICE

mechanical scraping of the dorso-posterior surface of the tongue

Tongue scraper

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Head & Neck Institute: lead
• Biolase Inc: collaborator
• Ohio State University: collaborator

Study Sites (1)

New York Head & Neck Institute offices

New York, New York, 10019, United States

Location

Related Publications (1)

• 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.

  PMID: 33045536 DERIVED

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 9, 2019
• Study Start: August 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)