Clinical Trial: Photodynamic Therapy in Adolescents Halitosis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Photodynamic Therapy as Novel Treatment for Halitosis in Adolescents: Crontolled Clinical Trial

Brief Summary:

The aim of the proposed controlled clinical trial is to evaluate the effect of photodynamic therapy (PDT) on the formation of volatile sulfur compounds (VSCs) from coated tongue and its action on the severity of halitosis in adolescents using different treatment protocols.

HYPOTHESIS

  1. - Null hypothesis: There is no change in halitosis following the use of photodynamic therapy.
  2. - Experimental hypothesis: There is a reduction in halitosis following the use of photodynamic therapy alone or in combination with a tongue scraper.

Detailed Summary:

Halitosis (bad breath) is a term used to describe an unpleasant odor emanating from the mouth that could originate in the oral cavity itself or as a result of systemic factors. Halitosis is a common problem that affects most of the population worldwide and is caused mainly by the volatile sulfur compounds produced by anaerobic Gram-negative microorganisms in the oral cavity on sulfur-containing substrates in the oral cavity. On the dorsum of the tongue, the volatile sulfur compounds produced from this metabolism are hydrogen sulfide (H2S), methyl mercaptan (CH3SH3) and dimethyl sulfide (CH3-S-CH3). The concentration of these gases is used as an indicator of the severity of halitosis. Recently, the Gram positive anaerobic bacterium Solobacterium moorei (formerly known as Bulleidia moorei) has also been associated with oral malodor by volatile sulfur compounds production, particularly hydrogen sulfide in the presence of different supplements with amino acids more specifically cysteine, wich agrees with studies showing that the cysteine challenge is a in vivo and in vitro model for analyzing the production of hydrogen sulfide.

The measure of volatile sulfur compounds can be performed by an organoleptic evaluation of the air emanating from the oral cavity through gas chromatography or the use of a sulfide monitor, such at the Halimeter (Interscan Corporation), which determines the amount of volatile sulfur compounds in parts per billion (ppb) in the exhaled air. Gas chromatography is the most appropriate means for detecting halitosis of different origins. In 2004, the Oral ChromaTM (Abilit Corporation) was developed in Japan for the individual measurement of the three main gases (hydrogen sulfide, methyl mercaptan and dimethyl sulfide), allowing the evaluation of the intensity and origin of halitosis.

Light, either alone or in
Sponsor: University of Nove de Julho

Current Primary Outcome: Halitosis Scores [ Time Frame: Prior to the initial photodynamic therapy on day 1 and 1, 24 and 168 hours post-photodynamic therapy ]

It will be compare de score of voalitile sulfur compounds in parts per billion (ppb) of hydrogen sulfide (H2S) and methyl mercaptan (CH3SH3).


Original Primary Outcome: Halitosis Scores [ Time Frame: All individuals will be submitted to evaluations with Oral ChromaTM before treatment and three times after treatment ]

The exam will be carried out 1 hour, 24 hours and a week after treatment to analyse the halitosis scores. It will be compare de score of volatile sulfur compounds in parts per billion (ppb) of hydrogen sulfide (H2S) and methyl mercaptan (CH3SH3).


Current Secondary Outcome: Microbiological Analysis [ Time Frame: Prior to the initial photodynamic therapy on day 1 and 1 and 24 hours post-photodynamic therapy ]

Microbiological analyses of coated tongue will be performed before and after treatment using a 1-μl inoculation loop for the collection of biofilm samples from the dorsum of the tongue. The samples will be transferred to 1.5-ml vials with reduced transport fluid and placed in a vortex mixer for approximately 30 seconds for homogenization. Ten-fold serial dilution will be prepared in 180 μl of sterile phosphate buffered saline and aliquots of 10-2, 10-3, 10-4 and 10-5 will be transferred to plates with brain heart infusion agar. As the main bacteria responsible for the production of VSCs are Gram-negative, the plates will be incubated in anaerobic jar for 72 h at 37 °C, following by the quantification of colony-forming units (CFUs)


Original Secondary Outcome:

Information By: University of Nove de Julho

Dates:
Date Received: November 26, 2013
Date Started: November 2013
Date Completion: October 2014
Last Updated: July 31, 2014
Last Verified: December 2013