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NCT Number: NCT05413993

Effect of Photobiomodulation on ph and Salivary Flow

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

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Key information

Conditions

Xerostomia Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nove de Julho Univ

São Paulo, 18133-399, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Photobiomodulation

Radiation

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

Primary outcomes

  1. Change in salivary flow

    Time frame: 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 outcomes

  1. Change in pH salivary

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

Immediate Effect Of Photobiomodulation On Ph And Salivary Flow: Quasi-Experimental Clinical Trial

Acronym: PBMSF

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 10, 2022
Registry last updated
Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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