Clinical trial NCT03973684: Evaluation of Halitosis After Treatment With Photodynamic Therapy
Official title: Evaluation of Halitosis After Treatment With Photodynamic Therapy Randomized and Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Halitosis
Keywords: bronchiectasis:
photodynamic therapy
periodontal disease
randomized controlled clinical study
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: bio-equivalence study enrollment: 80
Primary purpose: TREATMENT

Brief summary: Halitosis is the term used to define an unpleasant odor emanating from the mouth. Some lung diseases, such as bronchiectasis, are among the extra-oral causes of this condition. However, no studies have evaluated the reasons and treatment of halitosis in the population of adults with bronchiectasis. Methods and analysis: A randomized, controlled trial is proposed. Halitosis will be evaluated based on the measurement of volatile sulfur compounds (VSC) using gas chromatography. The participants (n=40) with halitosis and bronchiectasis will be randomized into two groups: G1-treatment with photodynamic therapy (n = 20) or G2-cleaning of the tongue with a tongue scraper (n = 20). After the treatments, a second evaluation will be performed, along with a microbiological analysis (qPCR) for the identification of the bacteria P. gingivalis and T. denticola. If the halitosis persists, the participants will receive periodontal treatment. The evaluation of halitosis and the microbiological analysis will be repeated. If the halitosis is solved, the participants will return after three months for an additional evaluation. This protocol will determine the effectiveness of phototherapy regarding the reduction of halitosis in healthy older adults and those with bronchiectasis.

Detailed description: A single-center, randomized, controlled, single-blind clinical trial was designed in accordance with the criteria recommended for interventional trials in the SPIRIT Statement. The project for the proposed study received approval from the Human Research Ethics Committee o fNove de Julho University(certificate number: 1057901).

Selection of individuals - characterization of sample - Two groups will be composed of adults in treatment at the dental clinic of Nove de Julho University. After verbal and written explanations of the study, those who agree to participate will sign a statement of informed consent approved by the Human Research Ethics Committee of Nove de Julho University. The study will be conducted in compliance with the precepts stipulated in the Declaration of Helsinki (revised in Fortaleza, Brazil, 2013).

Eligibility criteria: Inclusion Criteria:

* every age in both genders
* With diagnosis of bronchiectasis (experimental group)
* Patients clinically stable (compensated) (control group)
* Have more than 10 teeth
* Do not have any changes in the anatomy of the back of the tongue (geographical or fissured tongue)
* With positive halitosis, SH2 level \>112 ppb

Exclusion Criteria:

* Smokers or ex-smokers for less than 5 years
* Patients diagnosed with cystic fibrosis
* Patients with hypersensitivity to the photosensitizer

Primary outcomes:
measure: halitmetry (gas chromatography test)
timeFrame: study completion an average of 1 year
Secondary outcomes:
measure: microbiological analysis
timeFrame: before aPDT or scrapper , immediately after aPDT or scrapper , immediatly after periodontal treatment, 3 months later
Other outcomes:
measure: Oral Health Related Quality of life (OHRQoL)
timeFrame: before PDT or scrapper , 3 months after the halitosis treatment
Locations:
city: São Paulo
country: Brazil
facility: Anna Carolina R.T. Horliana
state: SP
Study officials:
affiliation: Nove de Julho University
name: Anna Carolina R Horliana, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schalch TO, Palmieri M, Longo PL, Braz-Silva PH, Tortamano IP, Michel-Crosato E, Mayer MPA, Jorge WA, Bussadori SK, Pavani C, Negreiros RM, Horliana ACRT. Evaluation of photodynamic therapy in pericoronitis: Protocol of randomized, controlled, double-blind study. Medicine (Baltimore). 2019 Apr;98(17):e15312. doi: 10.1097/MD.0000000000015312.
citation: da Cunha Moraes G, Vitoretti LB, de Brito AA, Alves CE, de Oliveira NCR, Dos Santos Dias A, Matos YST, Oliveira-Junior MC, Oliveira LVF, da Palma RK, Candeo LC, Lino-Dos-Santos-Franco A, Horliana ACRT, Gimenes Junior JA, Aimbire F, Vieira RP, Ligeiro-de-Oliveira AP. Low-Level Laser Therapy Reduces Lung Inflammation in an Experimental Model of Chronic Obstructive Pulmonary Disease Involving P2X7 Receptor. Oxid Med Cell Longev. 2018 Mar 4;2018:6798238. doi: 10.1155/2018/6798238. eCollection 2018.
citation: Costa-Santos L, Silva-Junior ZS, Sfalcin RA, Mota ACCD, Horliana ACRT, Motta LJ, Mesquita-Ferrari RA, Fernandes KPS, Prates RA, Silva DFT, Deana A, Bussadori SK. The effect of antimicrobial photodynamic therapy on infected dentin in primary teeth: A randomized controlled clinical trial protocol. Medicine (Baltimore). 2019 Apr;98(15):e15110. doi: 10.1097/MD.0000000000015110.
citation: Isabella APJ, Silva JTC, da Silva T, Rodrigues MFSD, Horliana ACRT, Motta LJ, Bussadori SK, Pavani C, Silva DFTD. Effect of irradiation with intravascular laser on the hemodynamic variables of hypertensive patients: Study protocol for prospective blinded randomized clinical trial. Medicine (Baltimore). 2019 Apr;98(14):e15111. doi: 10.1097/MD.0000000000015111.
citation: Ciarcia ACCDM, Goncalves MLL, Horliana ACRT, Suguimoto ESA, Araujo L, Laselva A, Mayer MPA, Motta LJ, Deana AM, Mesquita-Ferrari RA, Fernandes KPS, Bussadori SK. Action of antimicrobial photodynamic therapy with red leds in microorganisms related to halitose: Controlled and randomized clinical trial. Medicine (Baltimore). 2019 Jan;98(1):e13939. doi: 10.1097/MD.0000000000013939.