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Effect of Photobiomodulation on ph and Salivary Flow (PBMSF)

Primary Purpose

Xerostomia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
photobiomodulation
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 focused on measuring saliva flow, photobiomodulation

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults over 18 years of age
  • healthy dentition.

Exclusion Criteria:

  • dental caries
  • gingivitis or other alterations in the oral cavity
  • who use medication that has the side effect of decreasing the salivary flow,
  • who have used an antibiotic or anti-inflammatory within the last 30 days,
  • diabetes.

Sites / Locations

  • Nove de Julho Univ

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

intra and extraoral application

extraoral application

Arm Description

The laser was applied for 60 seconds, in 2 intraoral points and 2 extraoral points.

The laser was applied only extraoral points

Outcomes

Primary Outcome Measures

Change in salivary flow
The saliva was collected at the Dental Clinic of the Universidade Nove de Julho, with the adult seated at the dental team. To obtain the stimulated saliva, we used sialogogue chewing for 5 minutes, and the saliva collection was performed, by expectoration of all the saliva accumulated in the mouth every 1 minute of chewing, inside graduated glass tubes. Stimulated saliva was collected before and immediately after laser application. This procedure is performed both in the extraoral application only, and in the intra and extraoral application. After collection, 3 drops of simethicone were used to eliminate gases and foam, and only after this procedure the volume of saliva collected was measured.

Secondary Outcome Measures

Change in pH salivary
The saliva tube was properly placed on a bench for immediate pH measurement with a colorimetric tape (MERCK Ⓡ Quimical, São Paulo, Brazil) inside the collecting device. The tape features a pH scale from 0 to 14.

Full Information

First Posted
June 2, 2022
Last Updated
June 7, 2022
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT05413993
Brief Title
Effect of Photobiomodulation on ph and Salivary Flow
Acronym
PBMSF
Official Title
Immediate Effect Of Photobiomodulation On Ph And Salivary Flow: Quasi-Experimental Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
April 10, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Changes in salivary parameters, such as decreased flow, changes in pH and composition, can lead to changes in oral health. Saliva is responsible for the homeostasis of the oral cavity and is therefore directly related to the occurrence of caries, periodontitis, fungal and bacterial infections. These situations compromise the quality of life of the population and for this reason prevention and treatment strategies need to be studied and developed. Photobiomodulation is an alternative that has been increasingly practiced by health professionals. It consists of the application of light to a biological system that is capable of inducing a photochemical process, mainly in the mitochondria, thus stimulating the production of energy in the form of adenosine triphosphate (ATP), which can increase cellular metabolism and produce effects. as analgesia and tissue regeneration. In dentistry, studies using photobiomodulation have shown promise in improving some salivary parameters. This study aimed to compare the action of infrared light on salivary flow and pH, using two application techniques: extraoral (G1) and intra and extraoral (G2), with the application interval between the two techniques being 7 days
Detailed Description
This is a quasi-experimental clinical study evaluating the flow and salivary pH of healthy adults. The study was carried out with 20 adult patients at the Nove de Julho University. This study aimed to compare the action of infrared light on salivary flow and pH, using two application techniques: extraoral (G1) and intra and extraoral (G2), with the application interval between the two techniques being 7 days. The sample consisted of 20 healthy adults, who participated in both groups, thus being the actual control in the evaluations. Stimulated saliva was collected in both groups before and immediately after light application. In G1, a cluster with 3 spots was used, at a wavelength of 808 nanometers, power of 120 mW, with 24J of energy on the extraoral surface, for 67 seconds, in the region of the parotid gland, region of the submandibular and sublingual glands bilaterally, totaling 4 application regions, with total deposited energy of 96 joules. In G2, the laser was applied for 60 seconds, in 2 intraoral and 2 extraoral points in the region of the parotid glands bilaterally, as well as 1 intraoral and 1 extraoral point in the regions of the submandibular and sublingual glands (totaling 16 points), with a central wavelength of 808 nm; continuous operating mode; power of 100mW; with an aperture diameter of 0.354 cm (with spacer); radiant energy of 6J per point, totaling 96 joules of energy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia
Keywords
saliva flow, photobiomodulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
QUASI-EXPERIMENTAL CLINICAL TRIAL
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intra and extraoral application
Arm Type
Active Comparator
Arm Description
The laser was applied for 60 seconds, in 2 intraoral points and 2 extraoral points.
Arm Title
extraoral application
Arm Type
Experimental
Arm Description
The laser was applied only extraoral points
Intervention Type
Radiation
Intervention Name(s)
photobiomodulation
Intervention Description
Laser application intraorals and extraoral points in the region of the salivary glands bilaterally
Primary Outcome Measure Information:
Title
Change in salivary flow
Description
The saliva was collected at the Dental Clinic of the Universidade Nove de Julho, with the adult seated at the dental team. To obtain the stimulated saliva, we used sialogogue chewing for 5 minutes, and the saliva collection was performed, by expectoration of all the saliva accumulated in the mouth every 1 minute of chewing, inside graduated glass tubes. Stimulated saliva was collected before and immediately after laser application. This procedure is performed both in the extraoral application only, and in the intra and extraoral application. After collection, 3 drops of simethicone were used to eliminate gases and foam, and only after this procedure the volume of saliva collected was measured.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Change in pH salivary
Description
The saliva tube was properly placed on a bench for immediate pH measurement with a colorimetric tape (MERCK Ⓡ Quimical, São Paulo, Brazil) inside the collecting device. The tape features a pH scale from 0 to 14.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults over 18 years of age healthy dentition. Exclusion Criteria: dental caries gingivitis or other alterations in the oral cavity who use medication that has the side effect of decreasing the salivary flow, who have used an antibiotic or anti-inflammatory within the last 30 days, diabetes.
Facility Information:
Facility Name
Nove de Julho Univ
City
São Paulo
State/Province
SP
ZIP/Postal Code
18133-399
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Photobiomodulation on ph and Salivary Flow

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