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Evaluation of Halitosis After Treatment With Photodynamic Therapy

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ClinicalTrials.gov Identifier: NCT03973684
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho

Tracking Information
First Submitted Date  ICMJE May 21, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date June 20, 2019
Estimated Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
halitmetry (gas chromatography test) [ Time Frame: study completion an average of 1 year ]
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and the participant will breathe through the nose with the mouth closed for one minute.The plunger will then be withdrawn to fill the chamber with air.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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03973684 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
microbiological analysis [ Time Frame: before aPDT or scrapper , immediately after aPDT or scrapper , immediatly after periodontal treatment ]
collecting biofilm sample from the region of the lingual dorsum with swab and identification of the bacteria P. gingivalis and T. denticola. Sample will be transferred to sterile tubes with tris-EDTA (Ethylenediamine tetraacetic acid). The analysis will be performed by PCR (polymerase Chain reaction) real time
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 3, 2019)
Oral Health Related Quality of life (OHRQoL) [ Time Frame: before aPDT or scrapper , immediately after aPDT or scrapper , immediatly after periodontal treatment ]
oral health related quality of life will be measured using halt (halitosis associated life quality test). The patient will respond 20 questions in a lickert point scale that ranges from 0 till 5, considering higher results as worse quality of life.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluation of Halitosis After Treatment With Photodynamic Therapy
Official Title  ICMJE Evaluation of Halitosis After Treatment With Photodynamic Therapy Randomized and Controlled Study
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 causes and treatment of halitosis in the population of adults with bronchiectasis. Methods and analysis: A randomized, controlled trial is proposed. The patients (n=80) with halitosis patients will be divided into two groups: G1- aPDT (Photodynamic Therapy) (n = 40); G2- tongue scraper, 10 teeth or more (n = 40). Halitosis will be evaluated based on the measurement of volatile sulfur compounds using gas chromatography. The participants will be randomized into two subgroups: treatment with photodynamic therapy (n = 40) or cleaning of the tongue with a tongue scraper (n = 40). 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 received periodontal treatment The evaluation of halitosis and the microbiological analysis will be repeated. If the halitosis is resolved, 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 ofNove 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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
bio-equivalence study enrollment: 80
Masking: Double (Participant, Investigator)
Masking Description:
Double (Participant ,investigator) Double Blind(Subject,Caregiver,Investigator,Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Halitosis
Intervention  ICMJE
  • Device: pdt experimental group

    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.

  • Other: tongue scraper 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
Study Arms  ICMJE
  • Active Comparator: aPDT group
    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.
    Interventions:
    • Device: pdt experimental group
    • Other: tongue scraper group
  • Experimental: experimental tongue scrapper group
    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
    Interventions:
    • Device: pdt experimental group
    • Other: tongue scraper group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2020
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, that is, they had an 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Anna Carolina R Horliana, phd 5513981999848 annacrth@gmail.com
Contact: Renata M Negreiros, phd 5511981588472 renata.matalon@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03973684
Other Study ID Numbers  ICMJE halitosis
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: there is no plan to make individual participant data (IPD) available to other researchers.
Responsible Party Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho
Study Sponsor  ICMJE University of Nove de Julho
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anna Carolina R Horliana, phd Nove de Julho University
PRS Account University of Nove de Julho
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP