HalitosisNCT02007993
Photodynamic Therapy in Adolescents Halitosis
A study testing PDT and Tongue Scraper in people with Halitosis, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Halitosis
- What is being tested?
- PDT and Tongue Scraper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 9Show fewer
- History of antibiotic treatment in previous month;
- Pregnancy;
- Hypersensitivity to the photosensitizing agent employed.
Trial locations and contacts
1 site in 1 country.
Sandra K Bussadori, phd contact
Brazil1 site, 1 recruiting
- Recruiting
Universidade Nove de Julho
SP, São Paulo, 01504-001
Rubia G Lopes, master, 551130782797, rubia.lopes.rl@gmail.com
Rubia G Lopes, master
About this study
Official title: Photodynamic Therapy as Novel Treatment for Halitosis in Adolescents: Crontolled Clinical Trial
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
- - Null hypothesis: There is no change in halitosis following the use of photodynamic therapy.
- - Experimental hypothesis: There is a reduction in halitosis following the use of photodynamic therapy alone or in combination with a tongue scraper.
Read the detailed description
Halitosis (bad breath) is a term used to describe an unpleasant odor emanating from the mouth that could originate in the oral cavity itself or as a result of systemic factors. Halitosis is a common problem that affects most of the population worldwide and is caused mainly by the volatile sulfur compounds produced by anaerobic Gram-negative microorganisms in the oral cavity on sulfur-containing substrates in the oral cavity. On the dorsum of the tongue, the volatile sulfur compounds produced from this metabolism are hydrogen sulfide (H2S), methyl mercaptan (CH3SH3) and dimethyl sulfide (CH3-S-CH3). The concentration of these gases is used as an indicator of the severity of halitosis. Recently, the Gram positive anaerobic bacterium Solobacterium moorei (formerly known as Bulleidia moorei) has also been associated with oral malodor by volatile sulfur compounds production, particularly hydrogen sulfide in the presence of different supplements with amino acids more specifically cysteine, wich agrees with studies showing that the cysteine challenge is a in vivo and in vitro model for analyzing the production of hydrogen sulfide.
The measure of volatile sulfur compounds can be performed by an organoleptic evaluation of the air emanating from the oral cavity through gas chromatography or the use of a sulfide monitor, such at the Halimeter (Interscan Corporation), which determines the amount of volatile sulfur compounds in parts per billion (ppb) in the exhaled air. Gas chromatography is the most appropriate means for detecting halitosis of different origins. In 2004, the Oral ChromaTM (Abilit Corporation) was developed in Japan for the individual measurement of the three main gases (hydrogen sulfide, methyl mercaptan and dimethyl sulfide), allowing the evaluation of the intensity and origin of halitosis.
Light, either alone or in combination with chemical compounds, has been used for its therapeutic and antimicrobial effects. Photodynamic therapy encompasses the simultaneous action of a light source and photosensitizing agent in the presence of oxygen in tissues. Individually, each of these substances is innocuous, but their interaction is capable of giving rise to cytotoxic species that lead to cell death.The advantage of this approach is the avoidance of the development of resistance on the part of the target bacteria and damage to the adjacent tissues, since the antimicrobial effect is confined to the area covered by the dye and irradiated by the light, acting quickly on the target organisms. The efficacy of photodynamic therapy depends on the energy dose and output power employed.
Evaluation of degree of halitosis:
The portable Oral ChromaTM device (Abilit, Japan) will be employed. This device uses a highly sensitive gas semiconductor sensor.It will be connected to the computer with a specific software program that allows the creation of a graph corresponding to the peaks and concentrations of gases, measuring the VSC thresholds (0 to 1000 ppb), with considerable precision after eight minutes.
Analysis of volatile sulfur compounds:
- Hydrogen sulfide: values greater than 112 ppb indicate halitosis (SH2 ≥ 112 ppb);
- Methyl mercaptan: values greater than 26 ppb indicate halitosis (CH3SH ≥ 26 ppb);
A quantitative, controlled, cross-sectional, clinical trial will be carried out involving 130 teenagers. All individuals will be submitted to evaluations with Oral ChromaTM for the diagnosis of halitosis (scores SH2 ≥ 112 ppb and CH3SH ≥ 26 ppb) at the beginning of the study. Three post-treatment evaluations will be carried out: one hour, 24 hours and one week after treatment. The subjects selected will be randomly allocated to five groups:
- Group 1 will receive treatment with a tongue scraper;
- Group 2 and 3will receive photodynamic therapy applied to the posterior two thirds of the dorsum of the tongue;
- Groups 4 and 5 will receive combined treatment (tongue scraper and photodynamic therapy).
The statistical analysis will include the chi-square test and Fisher's Exact Test. The Student's t-test and analysis of variance (ANOVA) will be used for the comparison of means. Pearson's correlation coefficients will be calculated to determine the strength of correlations between continuous variables. A 95% significance level will be considered on all statistical tests (p < 0.05).
- Conditions
- Halitosis
- Being tested
- PDT, Tongue Scraper
- Keywords
- Halitosis,, Photodynamic Therapy,, Adolescent
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDTOther
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
Tongue ScraperOther
The pacient will scrap the tongue 10 times.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Treatment with a tongue scraper Receives: Other: Tongue Scraper |
| Group 2 | Experimental | PDT wavelength = 660 nm Fluency = 320 J/cm2 Power = 100 milliwatt Energy = 9 J Time = 90 s Receives: Other: PDT |
| Group 4 | Experimental | Tongue scraper + PDT wavelength = 660 nm Fluency = 320 J/cm2 Power = 100 milliwatt Energy = 9 J Time = 90 s Receives: Other: PDT; Other: Tongue Scraper |
| Group 3 | Experimental | PDT wavelength = 660 nm Fluency = 428 J/cm2 Power = 100 milliwatt Energy = 12 J Time = 120 s Receives: Other: PDT |
| Group 5 | Experimental | Tongue scraper + PDT wavelength = 660 nm Fluency = 428 J/cm2 Power = 100 milliwatt Energy = 12 J Time = 120 s Receives: Other: PDT; Other: Tongue Scraper |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Prior to the initial photodynamic therapy on day 1 and 1, 24 and 168 hours post-photodynamic therapy
Secondary outcomes (1)
Microbiological Analysis
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)
Measured: Prior to the initial photodynamic therapy on day 1 and 1 and 24 hours post-photodynamic therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HalitosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubia Garcia Lopes, University of Nove de Julho
- Investigators
- Sandra K Bussadori, phd, Study director, University of Nove de JulhoRubia G Lopes, master, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007993
- Sponsor's protocol ID
- halitose01
- Status last verified
- Dec 2013
- First submitted
- 26 Nov 2013
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27248838Lopes 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.
PubMed 26510574Lopes 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.
PubMed 25394474
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy as Novel Treatment for Halitosis in Adolescents: Crontolled Clinical Trial
- ClinicalTrials.gov ID
- NCT02007993
- Acronym / sponsor ID
- halitose01
- Conditions
- Halitosis
- Keywords
- Halitosis,, Photodynamic Therapy,, Adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- - Null hypothesis: There is no change in halitosis following the use of photodynamic therapy.
- - Experimental hypothesis: There is a reduction in halitosis following the use of photodynamic therapy alone or in combination with a tongue scraper.
Detailed description
Halitosis (bad breath) is a term used to describe an unpleasant odor emanating from the mouth that could originate in the oral cavity itself or as a result of systemic factors. Halitosis is a common problem that affects most of the population worldwide and is caused mainly by the volatile sulfur compounds produced by anaerobic Gram-negative microorganisms in the oral cavity on sulfur-containing substrates in the oral cavity. On the dorsum of the tongue, the volatile sulfur compounds produced from this metabolism are hydrogen sulfide (H2S), methyl mercaptan (CH3SH3) and dimethyl sulfide (CH3-S-CH3). The concentration of these gases is used as an indicator of the severity of halitosis. Recently, the Gram positive anaerobic bacterium Solobacterium moorei (formerly known as Bulleidia moorei) has also been associated with oral malodor by volatile sulfur compounds production, particularly hydrogen sulfide in the presence of different supplements with amino acids more specifically cysteine, wich agrees with studies showing that the cysteine challenge is a in vivo and in vitro model for analyzing the production of hydrogen sulfide.
The measure of volatile sulfur compounds can be performed by an organoleptic evaluation of the air emanating from the oral cavity through gas chromatography or the use of a sulfide monitor, such at the Halimeter (Interscan Corporation), which determines the amount of volatile sulfur compounds in parts per billion (ppb) in the exhaled air. Gas chromatography is the most appropriate means for detecting halitosis of different origins. In 2004, the Oral ChromaTM (Abilit Corporation) was developed in Japan for the individual measurement of the three main gases (hydrogen sulfide, methyl mercaptan and dimethyl sulfide), allowing the evaluation of the intensity and origin of halitosis.
Light, either alone or in combination with chemical compounds, has been used for its therapeutic and antimicrobial effects. Photodynamic therapy encompasses the simultaneous action of a light source and photosensitizing agent in the presence of oxygen in tissues. Individually, each of these substances is innocuous, but their interaction is capable of giving rise to cytotoxic species that lead to cell death.The advantage of this approach is the avoidance of the development of resistance on the part of the target bacteria and damage to the adjacent tissues, since the antimicrobial effect is confined to the area covered by the dye and irradiated by the light, acting quickly on the target organisms. The efficacy of photodynamic therapy depends on the energy dose and output power employed.
Evaluation of degree of halitosis:
The portable Oral ChromaTM device (Abilit, Japan) will be employed. This device uses a highly sensitive gas semiconductor sensor.It will be connected to the computer with a specific software program that allows the creation of a graph corresponding to the peaks and concentrations of gases, measuring the VSC thresholds (0 to 1000 ppb), with considerable precision after eight minutes.
Analysis of volatile sulfur compounds:
- Hydrogen sulfide: values greater than 112 ppb indicate halitosis (SH2 ≥ 112 ppb);
- Methyl mercaptan: values greater than 26 ppb indicate halitosis (CH3SH ≥ 26 ppb);
A quantitative, controlled, cross-sectional, clinical trial will be carried out involving 130 teenagers. All individuals will be submitted to evaluations with Oral ChromaTM for the diagnosis of halitosis (scores SH2 ≥ 112 ppb and CH3SH ≥ 26 ppb) at the beginning of the study. Three post-treatment evaluations will be carried out: one hour, 24 hours and one week after treatment. The subjects selected will be randomly allocated to five groups:
- Group 1 will receive treatment with a tongue scraper;
- Group 2 and 3will receive photodynamic therapy applied to the posterior two thirds of the dorsum of the tongue;
- Groups 4 and 5 will receive combined treatment (tongue scraper and photodynamic therapy).
The statistical analysis will include the chi-square test and Fisher's Exact Test. The Student's t-test and analysis of variance (ANOVA) will be used for the comparison of means. Pearson's correlation coefficients will be calculated to determine the strength of correlations between continuous variables. A 95% significance level will be considered on all statistical tests (p < 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Tongue ScraperTreatment with a tongue scraper |
| Group 2 | Experimental | Other: PDTPDT wavelength = 660 nm Fluency = 320 J/cm2 Power = 100 milliwatt Energy = 9 J Time = 90 s |
| Group 4 | Experimental | Other: PDT, Other: Tongue ScraperTongue scraper + PDT wavelength = 660 nm Fluency = 320 J/cm2 Power = 100 milliwatt Energy = 9 J Time = 90 s |
| Group 3 | Experimental | Other: PDTPDT wavelength = 660 nm Fluency = 428 J/cm2 Power = 100 milliwatt Energy = 12 J Time = 120 s |
| Group 5 | Experimental | Other: PDT, Other: Tongue ScraperTongue scraper + PDT wavelength = 660 nm Fluency = 428 J/cm2 Power = 100 milliwatt Energy = 12 J Time = 120 s |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- Dental-facial anomalies;
- Currently undergoing orthodontic and/or orthopedic treatment;
- Use of removable appliance, implant or denture;
- Periodontal disease;
- Teeth with carious lesions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDTA 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 | Group 2, Group 3, Group 4, Group 5 |
| Tongue ScraperThe pacient will scrap the tongue 10 times. | Other | Group 1, Group 4, Group 5 |
Primary outcome
Halitosis Scores
Time frame: Prior to the initial photodynamic therapy on day 1 and 1, 24 and 168 hours post-photodynamic therapy
It will be compare de score of voalitile sulfur compounds in parts per billion (ppb) of hydrogen sulfide (H2S) and methyl mercaptan (CH3SH3).
1 secondary outcome
Microbiological Analysis
Time frame: Prior to the initial photodynamic therapy on day 1 and 1 and 24 hours post-photodynamic therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2014.
- Derived from this study: PubMed 27248838Costa 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.
- Derived from this study: PubMed 26510574Lopes 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.
- Derived from this study: PubMed 25394474Lopes 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.
Related trials for Halitosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
The Effect of Regular Home Use of Dual-light Antibacterial Photodynamic Therapy (aPDT) or the Use of a Powered Toothbrush in Older Individuals With Periodontitis and Mild Cognitive Impairment.
Periodontal Diseases, Oral Halitosis
Active, not recruiting
Effects of Green Tea Mouthwash on Halitosis, Periodontal Health, and Stress in Orthodontic Patients
Halitosis, Periodontal Health
RecruitingPhase 2
Effectiveness of Aquamin® in Mitigating Halitosis
Healthy, Halitosis
Not yet recruiting
Effects of a 50+ Toothpaste on Halitosis and Oral Comfort in Healthy Adults
Oral Malodor (Halitosis), Oral Dryness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra K Bussadori, phd contact
Sandra K Bussadori, phd study director
University of Nove de Julho
Rubia G Lopes, master principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDT and Tongue Scraper in people with Halitosis, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rubia G Lopes, master (55 11 985939878, rubia.lopes.rl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Halitosis Scores (time frame: Prior to the initial photodynamic therapy on day 1 and 1, 24 and 168 hours post-photodynamic therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02007993, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2014.