HyposalivationNCT03049943
Low Level Laser Therapy for Hyposalivation
A study testing low level laser in people with Hyposalivation, run by University of Zagreb at 1 site in Croatia.
Trial summary
The aim of this study was to compare the effects of different wave lengths of LLLT on salivation in participants suffering from hyposalivation. This study included 30 participants whose major salivary glands were treated with low intensity diode laser BTL2000 (Medical Technologies, s.r.o., Czech Republic) during 10… Read more about this study
- Who is it for?
- Ages 52 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyposalivation
- What is being tested?
- low level laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCroatia
- Study dates
- 5 May 2014to 16 Sep 2014
- 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 52 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients suffering from hyposalivation, with medical histories free of radiotherapy and Sjögren's syndrome
Who cannot join
- medical histories of radiotherapy and Sjögren's syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Low Level Laser Protocols for Therapy of Hyposalivation
The aim of this study was to compare the effects of different wave lengths of LLLT on salivation in participants suffering from hyposalivation.
This study included 30 participants whose major salivary glands were treated with low intensity diode laser BTL2000 (Medical Technologies, s.r.o., Czech Republic) during 10 consecutive days. Patients were randomly assigned in two groups, each of 15 patients, and treated with LLLT of 830 nm and LLLT of 685 nm, respectively. The whole unstimulated and stimulated saliva was measured each day during 10 days, before and after laser treatment and 10th day after treatment was ended.
Read the detailed description
Low level laser treatment has proved to be effective for a wide range of oral pathologies including oral dryness, but the literature still lacks reports of clinical trials and protocols. The aim of this study was to evaluate the effects of two different laser wave lengths on salivation of patients suffering from hyposalivation. This with purpose to possibly find the optimum laser wavelength for the treatment, and to determine the better protocol for the patients suffering from hyposalivation. This study included 30 patients whose major salivary glands were treated with low intensity diode laser BTL2000 (Medical Technologies, s.r.o., Czech Republic) during 10 consecutive days. Patients were randomly assigned in two groups, each of 15 patients, and treated with LLLT of 830 nm and LLLT of 685 nm, respectively. The whole unstimulated and stimulated saliva was measured in graduated tubes each day during 10 days, before and after laser treatment and 10th day after treatment was ended.
- Conditions
- Hyposalivation
- Being tested
- low level laser
- Keywords
- low level laser therapy, hyposalivation
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laserDevice
| Study group | Role | What they receive |
|---|---|---|
| Laser wavelength of 830 nm | Active comparator | This group comprised 15 female patients with hyposalivation whose major salivary glands were treated for 10 consecutive days with low level laser therapy of 830 nm.The whole unstimulated and stimulated saliva was measured each day during 10 days, before and after laser treatment and 10th day after treatment was ended. Receives: Device: low level laser |
| Laser wavelength of 685 nm | Experimental | This group comprised 15 female patients with hyposalivation whose major salivary glands were treated for 10 consecutive days with low level laser therapy of 685 nm.The whole unstimulated and stimulated saliva was measured each day during 10 days, before and after laser treatment and 10th day after treatment was ended. Receives: Device: low level laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in average salivary flow rate, before and after low level laser treatment
The whole unstimulated and stimulated saliva was measured each day during 10 days, before and after laser treatment
Measured: 10 days
Secondary outcomes (1)
Average salivary flow rate
Average salivary flow rate 10th day after the end of LLLT
Measured: 1 day (Average salivary flow rate 10th day after the end of LLLT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start5 May 2014
- Primary completion16 Sep 2014
- Study completion16 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyposalivationStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Božana Lončar Brzak, University of Zagreb
- Investigators
- Božana Lončar Brzak, Assist.Prof., Principal investigator, School of Dental Medicine, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049943
- Sponsor's protocol ID
- 05/05/2012
- Status last verified
- Feb 2017
- First submitted
- 3 Feb 2017
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loncar B, Stipetic MM, Baricevic M, Risovic D. The effect of low-level laser therapy on salivary glands in patients with xerostomia. Photomed Laser Surg. 2011 Mar;29(3):171-5. doi: 10.1089/pho.2010.2792. Epub 2010 Nov 6.
PubMed 21054200
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Low Level Laser Protocols for Therapy of Hyposalivation
- ClinicalTrials.gov ID
- NCT03049943
- Acronym / sponsor ID
- 05/05/2012
- Conditions
- Hyposalivation
- Keywords
- low level laser therapy, hyposalivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 5 May 2014 (actual)
- Primary completion
- 16 Sep 2014 (actual)
- Study completion
- 16 Sep 2014 (actual)
- First posted
- 10 Feb 2017 (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.
The aim of this study was to compare the effects of different wave lengths of LLLT on salivation in participants suffering from hyposalivation.
This study included 30 participants whose major salivary glands were treated with low intensity diode laser BTL2000 (Medical Technologies, s.r.o., Czech Republic) during 10 consecutive days. Patients were randomly assigned in two groups, each of 15 patients, and treated with LLLT of 830 nm and LLLT of 685 nm, respectively. The whole unstimulated and stimulated saliva was measured each day during 10 days, before and after laser treatment and 10th day after treatment was ended.
Detailed description
Low level laser treatment has proved to be effective for a wide range of oral pathologies including oral dryness, but the literature still lacks reports of clinical trials and protocols. The aim of this study was to evaluate the effects of two different laser wave lengths on salivation of patients suffering from hyposalivation. This with purpose to possibly find the optimum laser wavelength for the treatment, and to determine the better protocol for the patients suffering from hyposalivation. This study included 30 patients whose major salivary glands were treated with low intensity diode laser BTL2000 (Medical Technologies, s.r.o., Czech Republic) during 10 consecutive days. Patients were randomly assigned in two groups, each of 15 patients, and treated with LLLT of 830 nm and LLLT of 685 nm, respectively. The whole unstimulated and stimulated saliva was measured in graduated tubes each day during 10 days, before and after laser treatment and 10th day after treatment was ended.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser wavelength of 830 nm | Active comparator | Device: low level laserThis group comprised 15 female patients with hyposalivation whose major salivary glands were treated for 10 consecutive days with low level laser therapy of 830 nm.The whole unstimulated and stimulated saliva was measured each day during 10 days, before and after laser treatment and 10th day after treatment was ended. |
| Laser wavelength of 685 nm | Experimental | Device: low level laserThis group comprised 15 female patients with hyposalivation whose major salivary glands were treated for 10 consecutive days with low level laser therapy of 685 nm.The whole unstimulated and stimulated saliva was measured each day during 10 days, before and after laser treatment and 10th day after treatment was ended. |
Who may qualify
- Ages
- 52 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients suffering from hyposalivation, with medical histories free of radiotherapy and Sjögren's syndrome
Key exclusion criteria (1 listed)
- medical histories of radiotherapy and Sjögren's syndrome
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 laser | Device | Laser wavelength of 685 nm, Laser wavelength of 830 nm |
Primary outcome
Difference in average salivary flow rate, before and after low level laser treatment
Time frame: 10 days
The whole unstimulated and stimulated saliva was measured each day during 10 days, before and after laser treatment
1 secondary outcome
Average salivary flow rate
Time frame: 1 day (Average salivary flow rate 10th day after the end of LLLT)
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 10 Feb 2017.
- Results publication: PubMed 21054200Loncar B, Stipetic MM, Baricevic M, Risovic D. The effect of low-level laser therapy on salivary glands in patients with xerostomia. Photomed Laser Surg. 2011 Mar;29(3):171-5. doi: 10.1089/pho.2010.2792. Epub 2010 Nov 6.
- Individual participant dataSharing planned: No
Related trials for Hyposalivation
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
Sjögren's Disease
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1
A Study of ATG-201 in Adult Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Systemic Sclerosis (SSc)
RecruitingPhase 2
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
Sjögren's Syndrome
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.
Božana Lončar Brzak, Assist.Prof. principal investigator
School of Dental Medicine, University of Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low level laser in people with Hyposalivation, run by University of Zagreb at 1 site in Croatia.
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 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. 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. 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?
Difference in average salivary flow rate, before and after low level laser treatment (time frame: 10 days). 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 NCT03049943, which also lists 1 linked publication.
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 10 Feb 2017.