search
Back to results

Evaluation of Halitosis After Treatment With Photodynamic Therapy

Primary Purpose

Halitosis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
pdt experimental group
tongue scraper group
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Halitosis focused on measuring bronchiectasis:, photodynamic therapy, periodontal disease, randomized controlled clinical study

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Anna Carolina R.T. Horliana

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

aPDT group

experimental tongue scrapper group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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and the participant will breathe through the nose with the mouth closed for one minute.The plunger will then be withdrawn to fill the chamber with air.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.

Secondary Outcome Measures

microbiological analysis
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

Full Information

First Posted
May 21, 2019
Last Updated
June 27, 2023
Sponsor
University of Nove de Julho
search

1. Study Identification

Unique Protocol Identification Number
NCT03973684
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis
Keywords
bronchiectasis:, photodynamic therapy, periodontal disease, randomized controlled clinical study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
bio-equivalence study enrollment: 80
Masking
ParticipantInvestigator
Masking Description
Double (Participant ,investigator) Double Blind(Subject,Caregiver,Investigator,Outcomes Assessor)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aPDT group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
experimental tongue scrapper group
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
pdt experimental group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
tongue scraper group
Intervention Description
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
Primary Outcome Measure Information:
Title
halitmetry (gas chromatography test)
Description
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.
Time Frame
study completion an average of 1 year
Secondary Outcome Measure Information:
Title
microbiological analysis
Description
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
Time Frame
before aPDT or scrapper , immediately after aPDT or scrapper , immediatly after periodontal treatment, 3 months later
Other Pre-specified Outcome Measures:
Title
Oral Health Related Quality of life (OHRQoL)
Description
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.
Time Frame
before PDT or scrapper , 3 months after the halitosis treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Carolina R Horliana, PhD
Organizational Affiliation
Nove de Julho University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anna Carolina R.T. Horliana
City
São Paulo
State/Province
SP
ZIP/Postal Code
11030-480
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
there is no plan to make individual participant data (IPD) available to other researchers.
Citations:
PubMed Identifier
31027098
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.
Results Reference
background
PubMed Identifier
29686745
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.
Results Reference
background
PubMed Identifier
30985667
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.
Results Reference
result
PubMed Identifier
30946378
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.
Results Reference
result
PubMed Identifier
30608426
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.
Results Reference
result

Learn more about this trial

Evaluation of Halitosis After Treatment With Photodynamic Therapy

We'll reach out to this number within 24 hrs