NCT05413993

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

June 2, 2022

Last Update Submit

June 7, 2022

Conditions

Keywords

saliva flowphotobiomodulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 minutes

Secondary Outcomes (1)

  • Change in pH salivary

    30 minutes

Study Arms (2)

intra and extraoral application

ACTIVE COMPARATOR

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

Radiation: photobiomodulation

extraoral application

EXPERIMENTAL

The laser was applied only extraoral points

Radiation: photobiomodulation

Interventions

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

extraoral applicationintra and extraoral application

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nove de Julho Univ

São Paulo, São Paulo, 18133-399, Brazil

Location

MeSH Terms

Conditions

Xerostomia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: QUASI-EXPERIMENTAL CLINICAL TRIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 10, 2022

Study Start

March 10, 2022

Primary Completion

April 10, 2022

Study Completion

May 20, 2022

Last Updated

June 10, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations