Trial record 3 of 7 for:    Open Studies | "Halitosis"

Photodynamic Therapy in Adolescents Halitosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Nove de Julho
Sponsor:
Information provided by (Responsible Party):
Rubia Garcia Lopes, University of Nove de Julho
ClinicalTrials.gov Identifier:
NCT02007993
First received: November 26, 2013
Last updated: July 31, 2014
Last verified: December 2013
  Purpose

The aim of the proposed controlled clinical trial is to evaluate the effect of photodynamic therapy (PDT) on the formation of volatile sulfur compounds (VSCs) from coated tongue and its action on the severity of halitosis in adolescents using different treatment protocols.

HYPOTHESIS

  1. - Null hypothesis: There is no change in halitosis following the use of photodynamic therapy.
  2. - Experimental hypothesis: There is a reduction in halitosis following the use of photodynamic therapy alone or in combination with a tongue scraper.

Condition Intervention
Halitosis
Other: PDT
Other: Tongue Scraper

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Photodynamic Therapy as Novel Treatment for Halitosis in Adolescents: Crontolled Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Nove de Julho:

Primary Outcome Measures:
  • Halitosis Scores [ Time Frame: Prior to the initial photodynamic therapy on day 1 and 1, 24 and 168 hours post-photodynamic therapy ] [ Designated as safety issue: No ]
    It will be compare de score of voalitile sulfur compounds in parts per billion (ppb) of hydrogen sulfide (H2S) and methyl mercaptan (CH3SH3).


Secondary Outcome Measures:
  • Microbiological Analysis [ Time Frame: Prior to the initial photodynamic therapy on day 1 and 1 and 24 hours post-photodynamic therapy ] [ Designated as safety issue: No ]
    Microbiological analyses of coated tongue will be performed before and after treatment using a 1-μl inoculation loop for the collection of biofilm samples from the dorsum of the tongue. The samples will be transferred to 1.5-ml vials with reduced transport fluid and placed in a vortex mixer for approximately 30 seconds for homogenization. Ten-fold serial dilution will be prepared in 180 μl of sterile phosphate buffered saline and aliquots of 10-2, 10-3, 10-4 and 10-5 will be transferred to plates with brain heart infusion agar. As the main bacteria responsible for the production of VSCs are Gram-negative, the plates will be incubated in anaerobic jar for 72 h at 37 °C, following by the quantification of colony-forming units (CFUs)


Estimated Enrollment: 130
Study Start Date: November 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Treatment with a tongue scraper
Other: Tongue Scraper
The pacient will scrap the tongue 10 times.
Experimental: Group 2
PDT wavelength = 660 nm Fluency = 320 J/cm2 Power = 100 milliwatt Energy = 9 J Time = 90 s
Other: PDT

A single session of PDT will be performed with the Chimiolux® photosensitizer at a concentration of 0.005% applied over the middle and posterior thirds of the dorsum of the tongue.

Nine points will be irradiated, the device will be previously calibrated with a wavelength of 660 nm, power of 100 mW, energy of 9 joules for 90 seconds per point in Groups 2 and 4 and 12 joules for 120 second per point in Groups 3 and 5

Experimental: Group 4
Tongue scraper + PDT wavelength = 660 nm Fluency = 320 J/cm2 Power = 100 milliwatt Energy = 9 J Time = 90 s
Other: PDT

A single session of PDT will be performed with the Chimiolux® photosensitizer at a concentration of 0.005% applied over the middle and posterior thirds of the dorsum of the tongue.

Nine points will be irradiated, the device will be previously calibrated with a wavelength of 660 nm, power of 100 mW, energy of 9 joules for 90 seconds per point in Groups 2 and 4 and 12 joules for 120 second per point in Groups 3 and 5

Other: Tongue Scraper
The pacient will scrap the tongue 10 times.
Experimental: Group 3
PDT wavelength = 660 nm Fluency = 428 J/cm2 Power = 100 milliwatt Energy = 12 J Time = 120 s
Other: PDT

A single session of PDT will be performed with the Chimiolux® photosensitizer at a concentration of 0.005% applied over the middle and posterior thirds of the dorsum of the tongue.

Nine points will be irradiated, the device will be previously calibrated with a wavelength of 660 nm, power of 100 mW, energy of 9 joules for 90 seconds per point in Groups 2 and 4 and 12 joules for 120 second per point in Groups 3 and 5

Experimental: Group 5
Tongue scraper + PDT wavelength = 660 nm Fluency = 428 J/cm2 Power = 100 milliwatt Energy = 12 J Time = 120 s
Other: PDT

A single session of PDT will be performed with the Chimiolux® photosensitizer at a concentration of 0.005% applied over the middle and posterior thirds of the dorsum of the tongue.

Nine points will be irradiated, the device will be previously calibrated with a wavelength of 660 nm, power of 100 mW, energy of 9 joules for 90 seconds per point in Groups 2 and 4 and 12 joules for 120 second per point in Groups 3 and 5

Other: Tongue Scraper
The pacient will scrap the tongue 10 times.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed statement of informed consent;
  • Authorization by legal guardian for the diagnosis and treatment of halitosis (Appendix 2);
  • Halitosis score using cysteine: S2H ≥ 112 ppb and/or CH3SH ≥ 26 ppb (Oral ChromaTM).

Exclusion Criteria:

  • Dental-facial anomalies;
  • Currently undergoing orthodontic and/or orthopedic treatment;
  • Use of removable appliance, implant or denture;
  • Periodontal disease;
  • Teeth with carious lesions;
  • Currently undergoing cancer treatment;
  • History of antibiotic treatment in previous month;
  • Pregnancy;
  • Hypersensitivity to the photosensitizing agent employed.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02007993

Contacts
Contact: Rubia G Lopes, master 55 11 985939878 rubia.lopes.rl@gmail.com
Contact: Sandra K Bussadori, phd sandra.skb@gmail.com

Locations
Brazil
Universidade Nove de Julho Recruiting
SP, Brazil, 01504-001
Contact: Rubia G Lopes, master    551130782797    rubia.lopes.rl@gmail.com   
Principal Investigator: Rubia G Lopes, master         
Sponsors and Collaborators
University of Nove de Julho
Investigators
Study Director: Sandra K Bussadori, phd University of Nove de Julho
Principal Investigator: Rubia G Lopes, master University of Nove de Julho
  More Information

No publications provided

Responsible Party: Rubia Garcia Lopes, master's degree student, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02007993     History of Changes
Other Study ID Numbers: halitose01
Study First Received: November 26, 2013
Last Updated: July 31, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Nove de Julho:
Halitosis,
Photodynamic Therapy,
Adolescent

Additional relevant MeSH terms:
Halitosis
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014