Laser Tongue Debridement for Oral Malodor

New York Head & Neck Institute

Status: Completed

Conditions: Halitosis

Treatments: Device: Waterlase Express Laser System; Device: Tongue scraper

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04120948

NY Head and Neck

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Waterlase Express Laser System

Experimental group

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.

Treatment:

Device: Waterlase Express Laser System

Tongue scraper

Active Comparator group

Description:

tongue scraping

Treatment:

Device: Tongue scraper