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Laser Tongue Debridement for Oral Malodor

Laser Tongue Debridement for Oral Malodor

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04120948
Enrollment
54
Registered
2019-10-09
Start date
2018-08-01
Completion date
2018-10-01
Last updated
2019-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Halitosis

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.

Interventions

DEVICEWaterlase 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.

mechanical scraping of the dorso-posterior surface of the tongue

Sponsors

Biolase Inc
CollaboratorINDUSTRY
Ohio State University
CollaboratorOTHER
New York Head & Neck Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Halimeter measurementchange from baseline to 1 monthMeasurement of volatile sulfur compounds in patient's breath.

Secondary

MeasureTime frameDescription
HALT questionnairechange from baseline to 1 monthQuality 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

MeasureTime frameDescription
bacterial loadchange from baseline to 1 monthSample is collected from the dorsal tongue surface. Total anaerobic and aerobic bacterial colonies are counted (CFU).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026