Photodynamic therapy as a novel treatment for halitosis in adolescents: study protocol for a randomized controlled trial

Rubia Garcia Lopes, Camila Haddad Leal de Godoy, Alessandro Melo Deana, Maria Eugenia Simões Onofre de Santi, Renato Araujo Prates, Cristiane Miranda França, Kristianne Porta Santos Fernandes, Raquel Agnelli Mesquita-Ferrari, Sandra Kalil Bussadori, Rubia Garcia Lopes, Camila Haddad Leal de Godoy, Alessandro Melo Deana, Maria Eugenia Simões Onofre de Santi, Renato Araujo Prates, Cristiane Miranda França, Kristianne Porta Santos Fernandes, Raquel Agnelli Mesquita-Ferrari, Sandra Kalil Bussadori

Abstract

Background: Halitosis is a common problem that affects a large portion of the population worldwide. The origin of this condition is oral in 90% and systemic in 10% of cases. The unpleasant odor is mainly the result of volatile sulfur compounds produced by Gram-negative bacteria. However, it has recently been found that anaerobic Gram-positive bacteria also produce hydrogen sulfide (H2S) in the presence of amino acids, such as cysteine. Light, both with and without the use of chemical agents, has been used to induce therapeutic and antimicrobial effects. In photodynamic therapy, the antimicrobial effect is confined to areas covered by photosensitizing dye. The aim of the present study is to evaluate the antimicrobial effect of photodynamic therapy on halitosis in adolescents through the analysis of volatile sulfur compounds measured using gas chromatography and microbiological analysis of coated tongue.

Methods/design: A quantitative clinical trial will be carried out involving 60 adolescents randomly divided into the following groups: group 1 will receive treatment with a tongue scraper, group 2 will receive photodynamic therapy applied to the posterior two-thirds of the dorsum of the tongue, and group 3 will receive combined treatment (tongue scraper and photodynamic therapy). Gas chromatography (OralChromaTM) and microbiological analysis will be used for the diagnosis of halitosis at the beginning of the study. Post-treatment evaluations will be conducted at one hour and 24 hours after treatment. The statistical analysis will include the Shapiro-Wilk test for the determination of the distribution of the data. If normal distribution is demonstrated, analysis of variance followed by Tukey's test will be used to compare groups. The Kruskal-Wallis test followed by the Student-Newman-Keuls test will be used for data with non-normal distribution. Either the paired t-test or the Wilcoxon test will be used to compare data before and after treatment, depending on the distribution of the data.

Discussion: The results of this trial will determine the efficacy of using photodynamic therapy alone or in combination with a tongue scraper to treat bad breath in adolescents.

Trial registration: The protocol for this study was registered with Clinical Trials (registration number NCT02007993) on 10 December 2013.

Figures

Figure 1
Figure 1
Flowchart of study. P = output power; E = energy and T = time in seconds.
Figure 2
Figure 2
Process for the acquisition of the sample for the halimetric. OralChroma (Abiliti Corporation, Chuo-ku, Osaka – Japan). The OralChroma™ will be connected to the computer with a specific software program that allows the creation of a graph corresponding to the peaks and concentrations of VSCs (0 to 2913 ppb) with considerable precision after eight minutes. The results are stored in the program, as well as in the device itself, and can be retrieved at any time for comparisons of the readings before, during and after treatment.
Figure 3
Figure 3
Points of photodynamic therapy application.
Figure 4
Figure 4
Diagram of tongue scraper use.

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