TrismusNCT02602431
Low Laser Light Therapy After Impacted Third Molar Removal
A study testing Extra-oral laser irradiation and Intra-oral laser irradiation in people with Trismus and Edema, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Third molars extraction is a surgery frequently performed in dentistry. It is generally associated to a great postoperative distress rendered by pain, swelling and trismus, caused by surgical trauma inflammation. Several methods have been proposed to prevent these complications and to increase tissue repair quality. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- What is being tested?
- Extra-oral laser irradiation and Intra-oral laser irradiation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Jul 2016
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- necessity of bilateral impacted third molar removal with similar dental arch positioning and similar surgical difficulty.
Who cannot join
- Compromised Systemic Health status, Neurologic and/or mental disorders, local infection history, anti-inflammatory or analgesic use for the last 15 days, tabagism, ethylism, pregnancy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Maria Cristina Zindel Deboni
São Paulo, São Paulo, 05508-000
Maria Cristina Deboni, PhD, +5511984269925, mczdebon@usp.br
Vinicius Paes Assis dos Santos, Trainee
About this study
Official title: A Unique Application of Low Laser Therapy After Third Molar Surgery: A Randomized Controlled Clinical Trial
Third molars extraction is a surgery frequently performed in dentistry. It is generally associated to a great postoperative distress rendered by pain, swelling and trismus, caused by surgical trauma inflammation. Several methods have been proposed to prevent these complications and to increase tissue repair quality. The use of low level laser therapy (LLLT) has been reported in dentistry since 1970. A large number of studies have reported the benefits of LLLT without collateral damage, positive effect as an anti-inflammatory agent and benefits in accelerating wound repair. However, some clinical applications strategies have been contradictories in everyday practice with results not always equivalent.
Objective: To verify if a single LLLT intra or extra oral application, singly, are analogous in their effects in controlling postoperative edema, trismus, pain and wound repair in third molar surgery.
Read the detailed description
30 healthy participants of both genders, with 18 to 35 years-of-age, with the necessity of inferior bilateral third molar removal will be selected. Inclusion criteria will consider the presence of upper central incisive and same surgical difficulty for third molar extraction. Participants that present chronic TMJ pain, neurological or psychiatric disorders, pericoronitis, anti-inflammatory or analgesic use for the last 15 days, bisphosphonates usage history at any time, tabagism, pregnancy or a family history of photosensitivity and hypersensibility to analgesics, anti-inflammatory or antibiotics will not be included. The surgical procedures will be randomized for the group to be assigned respecting the interval of one month between the surgeries.
Intra-oral group (IO) will be that in whose participant will receive the LLLT (Photon Lase III DMC equipment) with 660 nm wavelength, 100 mW of power, 107J / cm2 of power density, during 30 seconds, positioning the tip of the laser device in straight contact with each of the four points in the surgical area:
- corresponding to the occlusal surface of the tooth surgically extracted,
- in the middle third of the lingual surface, point
- the middle third of the buccal surface and point
- retro molar triangle region. Each point will receive energy 3J (Et= 12J).
The extra-oral group (EO) will receive phototherapy with the 808nm of wavelength following the same above protocol although positioning the laser point over the skin in straight contact with four points on the masseter muscle:
- next jaw insert,
- lower middle region,
- upper middle region
- near the insertion of the zygomatic arch.
In the IO group the extra-oral region will not be irradiated (the laser tip will be put in place without energy) in the EO group it will be done the opposite, so as the same patient will be the control because the participant will not be capable to identify which group he belongs to. The same investigator will perform surgical procedures and laser therapy. All participants will receive the same postoperative medication. Three distances will evaluate the range of edema: from tragus to the corner of the mouth, from gonial angle to the corner of the mouth and from gonial angle to the corner of the eye using a malleable millimeter rule. Trismus will be evaluated by the maximum range of mouth opening considering the inter-incisal distance between the edges of upper and lower right central incisors by a caliper in three moments: before surgery, 24 hours and 8 days after surgery. Participants will be asked to fill in a diary to assess the severity of postoperative pain on a visual analogue pain scale after the end of anesthetic effect: 4, 6, 8, 24, 48 hours postoperatively. The amount and time of medication will be also recorded. The quality of wound repair will be evaluated by two blinded calibrated observers, 24 hours and 8 days postoperatively in score from 0 to 3. The data will be submitted to appropriate statistical analysis for non-parametric samples.
- Being tested
- Extra-oral laser irradiation, Intra-oral laser irradiation, Extra-oral placebo, Intra-oral Placebo
- Keywords
- laser, third molar, low laser, inflammatory response
- Medical subject headings
- Trismus, Edema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-oral laser irradiationDevice
Also called DMC Photon Laser III
Irradiation will be employed extra oral by infra-red wave laser, 660nm, 100mW, and 107J/cm2 in four points of Masseter muscle for 30 seconds in each
Intra-oral laser irradiationDevice
Also called DMC Photn Laser III
Irradiation will be employed intra oral by red wave laser, 660nm, 100mW, and 107J/cm2 in four points for 30 seconds in each : 1. Superficial face of dental socket, 2. Lingual face; 3. buccal face and 4. Retromolar region
Extra-oral placeboDevice
Also called DMC Photn Laser III
Laser point will be placed over the same extra-oral points for 30 seconds in each point without irradiation on
Intra-oral PlaceboDevice
Also called DMC Photn Laser III
Laser point will be placed over the same intra-oral points for 30 seconds in each point without irradiation on
| Study group | Role | What they receive |
|---|---|---|
| Extra-oral laser irradiation | Active comparator | infra-red wave laser, 660nm, 100mW, and 107J/cm2 Receives: Device: Extra-oral laser irradiation |
| Extra-oral placebo | Placebo comparator | Laser point will be placed in region without irradiation on. Receives: Device: Extra-oral placebo |
| Intra-oral laser irradiation | Active comparator | red wave laser, 660nm, 100mW, and 107J/cm2 Receives: Device: Intra-oral laser irradiation |
| intra-oral placebo | Placebo comparator | Laser point will be placed in region without irradiation on. Receives: Device: Intra-oral Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Scores on the Visual Analog scale
measurements in a diary after anesthetic sensation had stopped and 4, 6, 8, 24, 48hours post operatively
Measured: 4, 6, 8, 24, 48hours post operative period
Secondary outcomes (2)
Edema percentage
measurement of face parameters dimension pre and post operative
Measured: 24 hours after surgery
mouth aperture in millimeters
comparison between maximum mouth aperture pre and post operatively
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startMar 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for TrismusStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Cristina Zindel Deboni, University of Sao Paulo
- Investigators
- Maria Cristina Deboni, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602431
- Sponsor's protocol ID
- 31861414.4.0000.0075
- Status last verified
- May 2016
- First submitted
- 8 Nov 2015
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Larrazabal C, Garcia B, Penarrocha M, Penarrocha M. Influence of oral hygiene and smoking on pain and swelling after surgical extraction of impacted mandibular third molars. J Oral Maxillofac Surg. 2010 Jan;68(1):43-6. doi: 10.1016/j.joms.2009.07.061.
PubMed 20006153Mehrabi M, Allen JM, Roser SM. Therapeutic agents in perioperative third molar surgical procedures. Oral Maxillofac Surg Clin North Am. 2007 Feb;19(1):69-84, vi. doi: 10.1016/j.coms.2006.11.010.
PubMed 18088865Markovic A, Todorovic Lj. Effectiveness of dexamethasone and low-power laser in minimizing oedema after third molar surgery: a clinical trial. Int J Oral Maxillofac Surg. 2007 Mar;36(3):226-9. doi: 10.1016/j.ijom.2006.10.006. Epub 2006 Dec 8.
PubMed 17157479Aras MH, Gungormus M. Placebo-controlled randomized clinical trial of the effect two different low-level laser therapies (LLLT)--intraoral and extraoral--on trismus and facial swelling following surgical extraction of the lower third molar. Lasers Med Sci. 2010 Sep;25(5):641-5. doi: 10.1007/s10103-009-0684-1. Epub 2009 May 31.
PubMed 19484402Brignardello-Petersen R, Carrasco-Labra A, Araya I, Yanine N, Beyene J, Shah PS. Is adjuvant laser therapy effective for preventing pain, swelling, and trismus after surgical removal of impacted mandibular third molars? A systematic review and meta-analysis. J Oral Maxillofac Surg. 2012 Aug;70(8):1789-801. doi: 10.1016/j.joms.2012.01.008. Epub 2012 Mar 6.
PubMed 22398186He WL, Yu FY, Li CJ, Pan J, Zhuang R, Duan PJ. A systematic review and meta-analysis on the efficacy of low-level laser therapy in the management of complication after mandibular third molar surgery. Lasers Med Sci. 2015 Aug;30(6):1779-88. doi: 10.1007/s10103-014-1634-0. Epub 2014 Aug 7.
PubMed 25098769Kazancioglu HO, Ezirganli S, Demirtas N. Comparison of the influence of ozone and laser therapies on pain, swelling, and trismus following impacted third-molar surgery. Lasers Med Sci. 2014 Jul;29(4):1313-9. doi: 10.1007/s10103-013-1300-y. Epub 2013 Mar 14.
PubMed 23494104Lopez-Ramirez M, Vilchez-Perez MA, Gargallo-Albiol J, Arnabat-Dominguez J, Gay-Escoda C. Efficacy of low-level laser therapy in the management of pain, facial swelling, and postoperative trismus after a lower third molar extraction. A preliminary study. Lasers Med Sci. 2012 May;27(3):559-66. doi: 10.1007/s10103-011-0936-8. Epub 2011 May 27.
PubMed 21617973Ferrante M, Petrini M, Trentini P, Perfetti G, Spoto G. Effect of low-level laser therapy after extraction of impacted lower third molars. Lasers Med Sci. 2013 May;28(3):845-9. doi: 10.1007/s10103-012-1174-4. Epub 2012 Jul 28.
PubMed 22843310Pallotta RC, Bjordal JM, Frigo L, Leal Junior EC, Teixeira S, Marcos RL, Ramos L, Messias Fde M, Lopes-Martins RA. Infrared (810-nm) low-level laser therapy on rat experimental knee inflammation. Lasers Med Sci. 2012 Jan;27(1):71-8. doi: 10.1007/s10103-011-0906-1. Epub 2011 Apr 12.
PubMed 21484455
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Unique Application of Low Laser Therapy After Third Molar Surgery: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02602431
- Acronym / sponsor ID
- 31861414.4.0000.0075
- Keywords
- laser, third molar, low laser, inflammatory response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 11 Nov 2015 (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.
Third molars extraction is a surgery frequently performed in dentistry. It is generally associated to a great postoperative distress rendered by pain, swelling and trismus, caused by surgical trauma inflammation. Several methods have been proposed to prevent these complications and to increase tissue repair quality. The use of low level laser therapy (LLLT) has been reported in dentistry since 1970. A large number of studies have reported the benefits of LLLT without collateral damage, positive effect as an anti-inflammatory agent and benefits in accelerating wound repair. However, some clinical applications strategies have been contradictories in everyday practice with results not always equivalent.
Objective: To verify if a single LLLT intra or extra oral application, singly, are analogous in their effects in controlling postoperative edema, trismus, pain and wound repair in third molar surgery.
Detailed description
30 healthy participants of both genders, with 18 to 35 years-of-age, with the necessity of inferior bilateral third molar removal will be selected. Inclusion criteria will consider the presence of upper central incisive and same surgical difficulty for third molar extraction. Participants that present chronic TMJ pain, neurological or psychiatric disorders, pericoronitis, anti-inflammatory or analgesic use for the last 15 days, bisphosphonates usage history at any time, tabagism, pregnancy or a family history of photosensitivity and hypersensibility to analgesics, anti-inflammatory or antibiotics will not be included. The surgical procedures will be randomized for the group to be assigned respecting the interval of one month between the surgeries.
Intra-oral group (IO) will be that in whose participant will receive the LLLT (Photon Lase III DMC equipment) with 660 nm wavelength, 100 mW of power, 107J / cm2 of power density, during 30 seconds, positioning the tip of the laser device in straight contact with each of the four points in the surgical area:
- corresponding to the occlusal surface of the tooth surgically extracted,
- in the middle third of the lingual surface, point
- the middle third of the buccal surface and point
- retro molar triangle region. Each point will receive energy 3J (Et= 12J).
The extra-oral group (EO) will receive phototherapy with the 808nm of wavelength following the same above protocol although positioning the laser point over the skin in straight contact with four points on the masseter muscle:
- next jaw insert,
- lower middle region,
- upper middle region
- near the insertion of the zygomatic arch.
In the IO group the extra-oral region will not be irradiated (the laser tip will be put in place without energy) in the EO group it will be done the opposite, so as the same patient will be the control because the participant will not be capable to identify which group he belongs to. The same investigator will perform surgical procedures and laser therapy. All participants will receive the same postoperative medication. Three distances will evaluate the range of edema: from tragus to the corner of the mouth, from gonial angle to the corner of the mouth and from gonial angle to the corner of the eye using a malleable millimeter rule. Trismus will be evaluated by the maximum range of mouth opening considering the inter-incisal distance between the edges of upper and lower right central incisors by a caliper in three moments: before surgery, 24 hours and 8 days after surgery. Participants will be asked to fill in a diary to assess the severity of postoperative pain on a visual analogue pain scale after the end of anesthetic effect: 4, 6, 8, 24, 48 hours postoperatively. The amount and time of medication will be also recorded. The quality of wound repair will be evaluated by two blinded calibrated observers, 24 hours and 8 days postoperatively in score from 0 to 3. The data will be submitted to appropriate statistical analysis for non-parametric samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Extra-oral laser irradiation | Active comparator | Device: Extra-oral laser irradiationinfra-red wave laser, 660nm, 100mW, and 107J/cm2 |
| Extra-oral placebo | Placebo comparator | Device: Extra-oral placeboLaser point will be placed in region without irradiation on. |
| Intra-oral laser irradiation | Active comparator | Device: Intra-oral laser irradiationred wave laser, 660nm, 100mW, and 107J/cm2 |
| intra-oral placebo | Placebo comparator | Device: Intra-oral PlaceboLaser point will be placed in region without irradiation on. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- necessity of bilateral impacted third molar removal with similar dental arch positioning and similar surgical difficulty.
Key exclusion criteria (1 listed)
- Compromised Systemic Health status, Neurologic and/or mental disorders, local infection history, anti-inflammatory or analgesic use for the last 15 days, tabagism, ethylism, pregnancy.
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 |
|---|---|---|
| Extra-oral laser irradiationAlso: DMC Photon Laser IIIIrradiation will be employed extra oral by infra-red wave laser, 660nm, 100mW, and 107J/cm2 in four points of Masseter muscle for 30 seconds in each | Device | Extra-oral laser irradiation |
| Intra-oral laser irradiationAlso: DMC Photn Laser IIIIrradiation will be employed intra oral by red wave laser, 660nm, 100mW, and 107J/cm2 in four points for 30 seconds in each : 1. Superficial face of dental socket, 2. Lingual face; 3. buccal face and 4. Retromolar region | Device | Intra-oral laser irradiation |
| Extra-oral placeboAlso: DMC Photn Laser IIILaser point will be placed over the same extra-oral points for 30 seconds in each point without irradiation on | Device | Extra-oral placebo |
| Intra-oral PlaceboAlso: DMC Photn Laser IIILaser point will be placed over the same intra-oral points for 30 seconds in each point without irradiation on | Device | intra-oral placebo |
Primary outcome
Change in Pain Scores on the Visual Analog scale
Time frame: 4, 6, 8, 24, 48hours post operative period
measurements in a diary after anesthetic sensation had stopped and 4, 6, 8, 24, 48hours post operatively
2 secondary outcomes
Edema percentage
Time frame: 24 hours after surgery
mouth aperture in millimeters
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Background: PubMed 20006153Larrazabal C, Garcia B, Penarrocha M, Penarrocha M. Influence of oral hygiene and smoking on pain and swelling after surgical extraction of impacted mandibular third molars. J Oral Maxillofac Surg. 2010 Jan;68(1):43-6. doi: 10.1016/j.joms.2009.07.061.
- Background: PubMed 18088865Mehrabi M, Allen JM, Roser SM. Therapeutic agents in perioperative third molar surgical procedures. Oral Maxillofac Surg Clin North Am. 2007 Feb;19(1):69-84, vi. doi: 10.1016/j.coms.2006.11.010.
- Background: PubMed 17157479Markovic A, Todorovic Lj. Effectiveness of dexamethasone and low-power laser in minimizing oedema after third molar surgery: a clinical trial. Int J Oral Maxillofac Surg. 2007 Mar;36(3):226-9. doi: 10.1016/j.ijom.2006.10.006. Epub 2006 Dec 8.
- Background: PubMed 19484402Aras MH, Gungormus M. Placebo-controlled randomized clinical trial of the effect two different low-level laser therapies (LLLT)--intraoral and extraoral--on trismus and facial swelling following surgical extraction of the lower third molar. Lasers Med Sci. 2010 Sep;25(5):641-5. doi: 10.1007/s10103-009-0684-1. Epub 2009 May 31.
- Background: PubMed 22398186Brignardello-Petersen R, Carrasco-Labra A, Araya I, Yanine N, Beyene J, Shah PS. Is adjuvant laser therapy effective for preventing pain, swelling, and trismus after surgical removal of impacted mandibular third molars? A systematic review and meta-analysis. J Oral Maxillofac Surg. 2012 Aug;70(8):1789-801. doi: 10.1016/j.joms.2012.01.008. Epub 2012 Mar 6.
- Background: PubMed 25098769He WL, Yu FY, Li CJ, Pan J, Zhuang R, Duan PJ. A systematic review and meta-analysis on the efficacy of low-level laser therapy in the management of complication after mandibular third molar surgery. Lasers Med Sci. 2015 Aug;30(6):1779-88. doi: 10.1007/s10103-014-1634-0. Epub 2014 Aug 7.
- Background: PubMed 23494104Kazancioglu HO, Ezirganli S, Demirtas N. Comparison of the influence of ozone and laser therapies on pain, swelling, and trismus following impacted third-molar surgery. Lasers Med Sci. 2014 Jul;29(4):1313-9. doi: 10.1007/s10103-013-1300-y. Epub 2013 Mar 14.
- Background: PubMed 21617973Lopez-Ramirez M, Vilchez-Perez MA, Gargallo-Albiol J, Arnabat-Dominguez J, Gay-Escoda C. Efficacy of low-level laser therapy in the management of pain, facial swelling, and postoperative trismus after a lower third molar extraction. A preliminary study. Lasers Med Sci. 2012 May;27(3):559-66. doi: 10.1007/s10103-011-0936-8. Epub 2011 May 27.
- Background: PubMed 22843310Ferrante M, Petrini M, Trentini P, Perfetti G, Spoto G. Effect of low-level laser therapy after extraction of impacted lower third molars. Lasers Med Sci. 2013 May;28(3):845-9. doi: 10.1007/s10103-012-1174-4. Epub 2012 Jul 28.
- Background: PubMed 21484455Pallotta RC, Bjordal JM, Frigo L, Leal Junior EC, Teixeira S, Marcos RL, Ramos L, Messias Fde M, Lopes-Martins RA. Infrared (810-nm) low-level laser therapy on rat experimental knee inflammation. Lasers Med Sci. 2012 Jan;27(1):71-8. doi: 10.1007/s10103-011-0906-1. Epub 2011 Apr 12.
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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.
Maria Cristina Deboni, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra-oral laser irradiation and Intra-oral laser irradiation in people with Trismus and Edema, run by University of Sao Paulo 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 1 inclusion and 1 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 11 May 2016. 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. Some participants in this study may receive a placebo. 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 Maria Cristina Deboni, PhD (11.55 28488185, mczdebon@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Scores on the Visual Analog scale (time frame: 4, 6, 8, 24, 48hours post operative period). 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 NCT02602431, which also lists 10 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 11 May 2016.