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Photobiomodulation in Salivary Production of Patients With Xerostomy

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ClinicalTrials.gov Identifier: NCT03632096
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Sandra Kalil Bussadori, University of Nove de Julho

Tracking Information
First Submitted Date  ICMJE August 3, 2018
First Posted Date  ICMJE August 15, 2018
Last Update Posted Date October 11, 2018
Actual Study Start Date  ICMJE September 10, 2018
Estimated Primary Completion Date December 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
Change from baseline Sialometry (measurement of the amount of produced saliva before and after treatment) [ Time Frame: One month. ]
The patient will be instructed to keep the head forward allowing all saliva to passively pass through the collection tube, resting on the lower lip, for five minutes. In the last second, the patient will be instructed to spit out all the accumulated saliva in the collection tube. The amount of saliva and foam will be evaluated and properly recorded. Then, the dimethicone (removal of the air bubbles) will be used to obtain the final result. At the end of the photobiomodulation sessions a sample of saliva will be collected to be compared to the initial sample. The measurement will be made as follows: milliliters of saliva produced per minute. For stimulate sialometry, a sialogogue will be used. The quantity will be classified as follows: Production of normal saliva: 1.5 to 3.0 ml/minute; Light hyposalivation: from 1.05 to 1.45 ml/minute; Moderate hyposalivation: 0.55 to 1.0 ml/minute; Severe hyposalivation: from 0.05 to 0.50 ml/minute; Sialorrhea: above 3.0 ml/min.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03632096 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photobiomodulation in Salivary Production of Patients With Xerostomy
Official Title  ICMJE Evaluation of Photobiomodulation in Salivary Production of Patients With Xerostomy Induced by Anti-hypertensive Drugs
Brief Summary Xerostomia is a quantitative and qualitative alteration of saliva, a symptom present in individuals who make continuous use of medications to control chronic diseases, including hypertension. Difficulties in mastication, swallowing, phonation and palate are present, besides oral burning syndrome, periodontal disease, root caries and bad breath that will interfere in the quality of life, making it difficult to socialize in society. Currently, the methods presented for treatment of xerostomia are palliative, so their use does not consist of an effective treatment. The objective of this study is to evaluate the efficacy of photobiomodulation in the production of saliva in patients with xerostomia induced by antihypertensive drugs. The method consists in the application of the low intensity laser in the three pairs of salivary glands - parotid, submandibular and sublingual. The parameters that will be used are: Laser Diode ArGaAl, DMC, 808nm, 4J per point, continuously and in contact with the irradiated surface, resulting in irradiance of 3571 mW/cm2, distributed as follows: 6 points in each parotid, 2 points in each sublingual (external) and two in each submandibular (internal), totaling 16 extra oral and 4 intra oral, totaling 20 points. The exposure time will be 40s per point, corresponding to 800s per session and 3600s at the end of the four treatment sessions. The radiant exposure will be 142J/cm2. The control group will have a simulation of the application of the laser, with the device turned off. Because it is an infrared light, it is invisible and this will not induce the patient to notice that the device is turned off. In the group that receives the photobiomodulation the device will have its timer turned off, to avoid the perception of sound difference. At the end of the sessions, a sample of saliva will be collected, which will be compared to the initial sample.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
The sham group will have a simulation of application of the laser, with the device turned off. Because it is an infrared light, it is invisible and this will not induce the patient to notice that the device is turned off. In the group that receives the photobiomodulation the device will have its timer turned off, to avoid the perception of sound difference.
Primary Purpose: Treatment
Condition  ICMJE Xerostomia
Intervention  ICMJE
  • Radiation: Photobiomodulation
    The parameters are: Laser Diode ArGaAl, DMC, 808nm, 4J per point, continuously and in contact with the irradiated surface, resulting in irradiance of 3571 mW/cm2, distributed as follows: 6 points in each parotid, 2 points in each sublingual (external) and two in each submandibular (internal), totaling 16 extra oral and 4 intra oral, totaling 20 points. The exposure time will be 40s per point, corresponding to 800s per session and 3600s at the end of the four treatment sessions. The radiant exposure will be 142J/cm2.
  • Radiation: Sham
    The sham group will have a simulation of laser application, following the same procedures as the active group, but with the device switched off.
Study Arms  ICMJE
  • Active Comparator: Photobiomodulation group
    Patients will receive 3 applications of low intensity light directly in the region of the three pairs of salivary glands already described. The ArGaAl diode laser, DMC 808nm 4J/point equipment will be used. The parameters that will be used are: Laser Diode ArGaAl, DMC, 808nm, 4J per point, continuously and in contact with the irradiated surface, resulting in irradiance of 3571 mW/cm2, distributed as follows: 6 points in each parotid, 2 points in each sublingual (external) and two in each submandibular (internal), totaling 16 extra oral and 4 intra oral, totaling 20 points. The exposure time will be 40s per point, corresponding to 800s per session and 3600s at the end of the four treatment sessions. The radiant exposure will be 142J/cm2. The first application will be after the stimulated collection of saliva and the following applications will be given once a week for another 2 weeks.
    Intervention: Radiation: Photobiomodulation
  • Sham Comparator: Sham group
    The placebo group will have a simulation of application of the laser, following the same technique as the active group, but with the device turned off. Because it is an infrared light, it is invisible and this will not induce the patient to notice that the device is turned off.
    Intervention: Radiation: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2018
Estimated Primary Completion Date December 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hypertensive patients using antihypertensive drugs who present xerostomia;
  • Hospitalized in the high-stay unit of the Mandaqui Hospital Complex;
  • Patients who sign the free and informed consent form.

Exclusion Criteria:

  • Patients with cancer in the oral region;
  • Patients receiving radiation therapy;
  • Patients with Sjögren's Syndrome;
  • Diabetics and those with any type of photosensitivity.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sandra K Bussadori, PhD +551126339000 sandra.skb@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03632096
Other Study ID Numbers  ICMJE Malu
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sandra Kalil Bussadori, University of Nove de Julho
Study Sponsor  ICMJE University of Nove de Julho
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Nove de Julho
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP