search
Back to results

Photobiomodulation in Salivary Production of Patients With Xerostomy

Primary Purpose

Xerostomia

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Photobiomodulation
Sham
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UniNoveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Photobiomodulation group

Sham group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline Sialometry (measurement of the amount of produced saliva before and after treatment)
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.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2018
Last Updated
October 10, 2018
Sponsor
University of Nove de Julho
search

1. Study Identification

Unique Protocol Identification Number
NCT03632096
Brief Title
Photobiomodulation in Salivary Production of Patients With Xerostomy
Official Title
Evaluation of Photobiomodulation in Salivary Production of Patients With Xerostomy Induced by Anti-hypertensive Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
December 10, 2018 (Anticipated)
Study Completion Date
December 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Photobiomodulation group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
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 Type
Radiation
Intervention Name(s)
Photobiomodulation
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Sham
Intervention Description
The sham group will have a simulation of laser application, following the same procedures as the active group, but with the device switched off.
Primary Outcome Measure Information:
Title
Change from baseline Sialometry (measurement of the amount of produced saliva before and after treatment)
Description
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.
Time Frame
One month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra K Bussadori, PhD
Phone
+551126339000
Email
sandra.skb@gmail.com
Facility Information:
Facility Name
UniNove
City
São Paulo
State/Province
SP
ZIP/Postal Code
01504-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra K Bussadori, PhD
Phone
1126339000

12. IPD Sharing Statement

Citations:
PubMed Identifier
32311925
Citation
Varellis MLZ, Goncalves MLL, Pavesi VCS, Horliana ACRT, de Fatima Teixeira da Silva D, Motta LJ, Barbosa Filho VF, Bezerra CDS, Silva FGD, Bussadori SK, Deana AM. Evaluation of photobiomodulation in salivary production of patients with xerostomy induced by anti-hypertensive drugs: Study protocol clinical trial (SPIRIT compliant). Medicine (Baltimore). 2020 Apr;99(16):e19583. doi: 10.1097/MD.0000000000019583.
Results Reference
derived

Learn more about this trial

Photobiomodulation in Salivary Production of Patients With Xerostomy

We'll reach out to this number within 24 hrs