Evaluation of Halitosis After Treatment With Photodynamic Therapy

NCT03973684 | Completed

• 1 other identifier: halitosis
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Halitosis

Keywords

bronchiectasis:; photodynamic therapy; periodontal disease; randomized controlled clinical study

Outcome Measures

Primary Outcomes (1)

• halitmetry (gas chromatography test)

  The portable Oral ChromaTM will be used for the assessment of halitosis. Oral air collection will follow the manufactured guide lines (Oral Chroma Manual Instruction). A syringe will be placed in the patient's mouth with the plunger completely inserted and the participant will breathe through the nose with the mouth closed for one minute.The plunger will then be withdrawn to fill the chamber with air. The gas injection needle will be placed on the syringe and the plunger will be adjusted to 0.5 ml. This air will be injected into the input of the device in a single motion. This procedure will be done before, immediately after aPDT or scraper and after periodontal treatment.

  study completion an average of 1 year

Secondary Outcomes (1)

• microbiological analysis

  before aPDT or scrapper , immediately after aPDT or scrapper , immediatly after periodontal treatment, 3 months later

Other Outcomes (1)

• Oral Health Related Quality of life (OHRQoL)

  before PDT or scrapper , 3 months after the halitosis treatment

Study Arms (2)

aPDT group

ACTIVE COMPARATOR

G1- 40 patient 40 patients will be included in this group. One section of Pdt will be performed with the photosensitizer (PS). PS will be applied in sufficience quantity to cover the middle third and back of the tongue and wait for 5 minutes.six points with the distances of 1 cm between them will be irradiated. The apparatus shall be precalibrated at wavelength 660nm for 90 seconds per point.

Device: pdt experimental group; Other: tongue scraper group

experimental tongue scrapper group

EXPERIMENTAL

40 patients will be included in this group. Tongue scrapping will be performed by the same operator in all patients. Posterior -anterior movements will be performed with the scrapper over the lingual dorsum. in order to promote the mechanical removal of tongue coating

Device: pdt experimental group; Other: tongue scraper group

Interventions

pdt experimental group DEVICE

G1-40 patients Photodynamic therapy with methylene blue as photosensitizer device irradiation with low intensity laser (wave length = 660 nm) 9J (Jaules) per point(6 points) and radiant 90 seconds PS will be applied in sufficient quantity to cover the middle third and back of the tongue and wait for 5 minutes.six points with the distances of 1 cm between them will be irradiated.

aPDT group; experimental tongue scrapper group

tongue scraper group OTHER

Tongue scrapping will be performed by the same operator in all patients. Posterior -anterior movements will be performed with the scrapper over the lingual dorsum. in order to promote the mechanical removal of tongue coating

aPDT group; experimental tongue scrapper group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Anna Carolina R.T. Horliana

São Paulo, São Paulo, 11030-480, Brazil

Location

Related Publications (5)

• 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.

  PMID: 31027098 BACKGROUND

• 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.

  PMID: 29686745 BACKGROUND

• 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.

  PMID: 30985667 RESULT

• 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.

  PMID: 30946378 RESULT

• 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.

  PMID: 30608426 RESULT

MeSH Terms

Conditions

Halitosis; Bronchiectasis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Anna Carolina R Horliana, PhD

  Nove de Julho University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant ,investigator) Double Blind(Subject,Caregiver,Investigator,Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd, clinical professor

Model Details: bio-equivalence study enrollment: 80

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: June 4, 2019
• Study Start: July 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: February 1, 2020
• Last Updated: June 29, 2023

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)