PhotobiomodulationxerosNCT05336981
Effect of Photobiomodulation for Patients With Xerostomia
A study testing Low-Level Light Therapy in people with Photobiomodulation and Low-Level Light Therapy, run by Pia Lopez Jornet at 2 sites in Spain.
Trial summary
Hyposalivation is a condition represented by a reduced salivary flow and may include symptoms such as mouth dryness (xerostomia), pain, loss of taste,dysphagia, and dysphonia, all of which greatly affect an individual's quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Photobiomodulation, Low-Level Light Therapy
- What is being tested?
- Low-Level Light Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2020to 26 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the inclusion criteria for participating in the study were: age over 18 years; continuous xerostomia for over three months; and/or altered sialometry findings at baseline (salivary flow < 0.1 mL/min).
Who cannot join
- The exclusion criteria were: xerostomia as secondary to radiotherapy; patients with decompensated systemic disorders or cognitive problems
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Lopez-Jornet Pia
Murcia, N/A = Not Applicable, 30008
Pia Lopez Jornet
Murcia, 30004
About this study
Hyposalivation is a condition represented by a reduced salivary flow and may include symptoms such as mouth dryness (xerostomia), pain, loss of taste,dysphagia, and dysphonia, all of which greatly affect an individual's quality of life.
The aim of the present study was analized the effects of low-level light therapy irradiation (photobiomodulation PBM) on salivary gland function in patients with hyposalivation
Read the detailed description
Inclusion criteria -the inclusion criteria for participating in the study were: age over 18 years; continuous xerostomia for over three months; and/or altered sialometry findings at baseline (salivary flow < 0.1 mL/min).
Exclusion criteria. : xerostomia as secondary to radiotherapy; patients with decompensated systemic disorders or cognitive problems
The 60 individuals will be randomized in 2 groups: Group A (30 individuals submitted to treatment with a PBM) and Group B (30 individuals submitted to simulated PBM). A total of 60 patients with xerostomia were enrolled in the study and cited once a week for a period of 6 weeks treatment with diode laser (810nm, 6J/cm2) or sham treatment (according to the group).
- Conditions
- Photobiomodulation, Low-Level Light Therapy
- Being tested
- Low-Level Light Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Light TherapyRadiation
The method consists of the application extraoral of low-intensity infrared laser in the major salivary glands-parotid, submandibular
| Study group | Role | What they receive |
|---|---|---|
| Low-Level Light Therapy ACTIVE | Experimental | Patients will receive applications of photobiomodulation directly in the region extraoral of the salivary glands ( parotid and submaxilar) will be given once a week for another 6 weeks. Receives: Radiation: Low-Level Light Therapy |
| Low-Level Light Therapy sham | Sham comparator | Patients will receive applications of photobiomodulation sham directly in the region extraoral of the salivary glands ( parotid and submaxilar) will be given once a week for another 6 weeks Receives: Radiation: Low-Level Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
xerostomia
Comparison of changes in mouth Dryness Score
Measured: Change (in centimeters measured on a Visual Analogue Scale) determined between day 0 and day 15 and 45 days
SIALOMETRY
Sialometry was performed using the passive droll technique.
Measured: before and after 45 days the procedure of laser therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Jan 2020
- Primary completion1 Jan 2021
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PhotobiomodulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pia Lopez Jornet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pia Lopez Jornet, Universidad de Murcia
- Investigators
- Pia Lopez Jornet, Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336981
- Sponsor's protocol ID
- University Murcia 1229/2015
- Acronym
- xeros
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalhori KAM, Vahdatinia F, Jamalpour MR, Vescovi P, Fornaini C, Merigo E, Fekrazad R. Photobiomodulation in Oral Medicine. Photobiomodul Photomed Laser Surg. 2019 Dec;37(12):837-861. doi: 10.1089/photob.2019.4706.
PubMed 31873066Brzak BL, Cigic L, Baricevic M, Sabol I, Mravak-Stipetic M, Risovic D. Different Protocols of Photobiomodulation Therapy of Hyposalivation. Photomed Laser Surg. 2018 Feb;36(2):78-82. doi: 10.1089/pho.2017.4325. Epub 2017 Oct 12.
PubMed 29022754
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Photobiomodulation for Patients With Xerostomia
- ClinicalTrials.gov ID
- NCT05336981
- Acronym / sponsor ID
- xeros / University Murcia 1229/2015
- Conditions
- Photobiomodulation, Low-Level Light Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pia Lopez JornetUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hyposalivation is a condition represented by a reduced salivary flow and may include symptoms such as mouth dryness (xerostomia), pain, loss of taste,dysphagia, and dysphonia, all of which greatly affect an individual's quality of life.
The aim of the present study was analized the effects of low-level light therapy irradiation (photobiomodulation PBM) on salivary gland function in patients with hyposalivation
Detailed description
Inclusion criteria -the inclusion criteria for participating in the study were: age over 18 years; continuous xerostomia for over three months; and/or altered sialometry findings at baseline (salivary flow < 0.1 mL/min).
Exclusion criteria. : xerostomia as secondary to radiotherapy; patients with decompensated systemic disorders or cognitive problems
The 60 individuals will be randomized in 2 groups: Group A (30 individuals submitted to treatment with a PBM) and Group B (30 individuals submitted to simulated PBM). A total of 60 patients with xerostomia were enrolled in the study and cited once a week for a period of 6 weeks treatment with diode laser (810nm, 6J/cm2) or sham treatment (according to the group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Level Light Therapy ACTIVE | Experimental | Radiation: Low-Level Light TherapyPatients will receive applications of photobiomodulation directly in the region extraoral of the salivary glands ( parotid and submaxilar) will be given once a week for another 6 weeks. |
| Low-Level Light Therapy sham | Sham comparator | Radiation: Low-Level Light TherapyPatients will receive applications of photobiomodulation sham directly in the region extraoral of the salivary glands ( parotid and submaxilar) will be given once a week for another 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the inclusion criteria for participating in the study were: age over 18 years; continuous xerostomia for over three months; and/or altered sialometry findings at baseline (salivary flow < 0.1 mL/min).
Key exclusion criteria (1 listed)
- The exclusion criteria were: xerostomia as secondary to radiotherapy; patients with decompensated systemic disorders or cognitive problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Level Light TherapyThe method consists of the application extraoral of low-intensity infrared laser in the major salivary glands-parotid, submandibular | Radiation | Low-Level Light Therapy ACTIVE, Low-Level Light Therapy sham |
Primary outcome
xerostomia
Time frame: Change (in centimeters measured on a Visual Analogue Scale) determined between day 0 and day 15 and 45 days
Comparison of changes in mouth Dryness Score
SIALOMETRY
Time frame: before and after 45 days the procedure of laser therapy
Sialometry was performed using the passive droll technique.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Background: PubMed 31873066Kalhori KAM, Vahdatinia F, Jamalpour MR, Vescovi P, Fornaini C, Merigo E, Fekrazad R. Photobiomodulation in Oral Medicine. Photobiomodul Photomed Laser Surg. 2019 Dec;37(12):837-861. doi: 10.1089/photob.2019.4706.
- Background: PubMed 29022754Brzak BL, Cigic L, Baricevic M, Sabol I, Mravak-Stipetic M, Risovic D. Different Protocols of Photobiomodulation Therapy of Hyposalivation. Photomed Laser Surg. 2018 Feb;36(2):78-82. doi: 10.1089/pho.2017.4325. Epub 2017 Oct 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pia Lopez Jornet principal investigator
Universidad de Murcia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Light Therapy in people with Photobiomodulation and Low-Level Light Therapy, run by Pia Lopez Jornet at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
xerostomia (time frame: Change (in centimeters measured on a Visual Analogue Scale) determined between day 0 and day 15 and 45 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05336981, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.