Photodynamic Therapy in Adolescents Halitosis
Photodynamic Therapy as Novel Treatment for Halitosis in Adolescents: Crontolled Clinical Trial
1 other identifier
interventional
130
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 26, 2013
CompletedFirst Posted
Study publicly available on registry
December 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedAugust 4, 2014
December 1, 2013
10 months
November 26, 2013
July 31, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Halitosis Scores
It will be compare de score of voalitile sulfur compounds in parts per billion (ppb) of hydrogen sulfide (H2S) and methyl mercaptan (CH3SH3).
Prior to the initial photodynamic therapy on day 1 and 1, 24 and 168 hours post-photodynamic therapy
Secondary Outcomes (1)
Microbiological Analysis
Prior to the initial photodynamic therapy on day 1 and 1 and 24 hours post-photodynamic therapy
Study Arms (5)
Group 1
ACTIVE COMPARATORTreatment with a tongue scraper
Group 2
EXPERIMENTALPDT wavelength = 660 nm Fluency = 320 J/cm2 Power = 100 milliwatt Energy = 9 J Time = 90 s
Group 4
EXPERIMENTALTongue scraper + PDT wavelength = 660 nm Fluency = 320 J/cm2 Power = 100 milliwatt Energy = 9 J Time = 90 s
Group 3
EXPERIMENTALPDT wavelength = 660 nm Fluency = 428 J/cm2 Power = 100 milliwatt Energy = 12 J Time = 120 s
Group 5
EXPERIMENTALTongue scraper + PDT wavelength = 660 nm Fluency = 428 J/cm2 Power = 100 milliwatt Energy = 12 J Time = 120 s
Interventions
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
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Nove de Julho
SP, São Paulo, 01504-001, Brazil
Related Publications (3)
Costa da Mota AC, Franca CM, Prates R, Deana AM, Costa Santos L, Lopes Garcia R, Leal Goncalves ML, Mesquita Ferrari RA, Porta Santos Fernandes K, Kalil Bussadori S. Effect of photodynamic therapy for the treatment of halitosis in adolescents - a controlled, microbiological, clinical trial. J Biophotonics. 2016 Dec;9(11-12):1337-1343. doi: 10.1002/jbio.201600067. Epub 2016 Jun 1.
PMID: 27248838DERIVEDLopes RG, da Mota AC, Soares C, Tarzia O, Deana AM, Prates RA, Franca CM, Fernandes KP, Ferrari RA, Bussadori SK. Immediate results of photodynamic therapy for the treatment of halitosis in adolescents: a randomized, controlled, clinical trial. Lasers Med Sci. 2016 Jan;31(1):41-7. doi: 10.1007/s10103-015-1822-6. Epub 2015 Oct 28.
PMID: 26510574DERIVEDLopes RG, de Godoy CH, Deana AM, de Santi ME, Prates RA, Franca CM, Fernandes KP, Mesquita-Ferrari RA, Bussadori SK. Photodynamic therapy as a novel treatment for halitosis in adolescents: study protocol for a randomized controlled trial. Trials. 2014 Nov 14;15:443. doi: 10.1186/1745-6215-15-443.
PMID: 25394474DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sandra K Bussadori, phd
University of Nove de Julho
- PRINCIPAL INVESTIGATOR
Rubia G Lopes, master
University of Nove de Julho
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- master's degree student
Study Record Dates
First Submitted
November 26, 2013
First Posted
December 11, 2013
Study Start
November 1, 2013
Primary Completion
September 1, 2014
Study Completion
October 1, 2014
Last Updated
August 4, 2014
Record last verified: 2013-12