PBMSF: Effect of Photobiomodulation on ph and Salivary Flow

Sponsor
University of Nove de Julho (Other)
Overall Status
Completed
CT.gov ID
NCT05413993
Collaborator
(none)
20
1
2
2.3
8.6

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: photobiomodulation
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
QUASI-EXPERIMENTAL CLINICAL TRIALQUASI-EXPERIMENTAL CLINICAL TRIAL
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Immediate Effect Of Photobiomodulation On Ph And Salivary Flow: Quasi-Experimental Clinical Trial
Actual Study Start Date :
Mar 10, 2022
Actual Primary Completion Date :
Apr 10, 2022
Actual Study Completion Date :
May 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: intra and extraoral application

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

Radiation: photobiomodulation
Laser application intraorals and extraoral points in the region of the salivary glands bilaterally

Experimental: extraoral application

The laser was applied only extraoral points

Radiation: photobiomodulation
Laser application intraorals and extraoral points in the region of the salivary glands bilaterally

Outcome Measures

Primary Outcome Measures

  1. Change in salivary flow [30 minutes]

    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

  1. Change in pH salivary [30 minutes]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nove de Julho Univ São Paulo SP Brazil 18133-399

Sponsors and Collaborators

  • University of Nove de Julho

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lara Jansiski Motta, PhD, University of Nove de Julho
ClinicalTrials.gov Identifier:
NCT05413993
Other Study ID Numbers:
  • PBMSF
First Posted:
Jun 10, 2022
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lara Jansiski Motta, PhD, University of Nove de Julho
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2022