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Low Level Laser Therapy for Hyposalivation

Primary Purpose

Hyposalivation

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
low level laser
Sponsored by
University of Zagreb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyposalivation focused on measuring low level laser therapy, hyposalivation

Eligibility Criteria

52 Years - 85 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • patients suffering from hyposalivation, with medical histories free of radiotherapy and Sjögren's syndrome

Exclusion Criteria:

  • medical histories of radiotherapy and Sjögren's syndrome

Sites / Locations

  • School of Dental Medicine, University of Zagreb

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Laser wavelength of 830 nm

Laser wavelength of 685 nm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Average salivary flow rate
Average salivary flow rate 10th day after the end of LLLT

Full Information

First Posted
February 3, 2017
Last Updated
February 9, 2017
Sponsor
University of Zagreb
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1. Study Identification

Unique Protocol Identification Number
NCT03049943
Brief Title
Low Level Laser Therapy for Hyposalivation
Official Title
Different Low Level Laser Protocols for Therapy of Hyposalivation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 5, 2014 (Actual)
Primary Completion Date
September 16, 2014 (Actual)
Study Completion Date
September 16, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zagreb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyposalivation
Keywords
low level laser therapy, hyposalivation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser wavelength of 830 nm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Laser wavelength of 685 nm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
low level laser
Primary Outcome Measure Information:
Title
Difference in average salivary flow rate, before and after low level laser treatment
Description
The whole unstimulated and stimulated saliva was measured each day during 10 days, before and after laser treatment
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Average salivary flow rate
Description
Average salivary flow rate 10th day after the end of LLLT
Time Frame
1 day (Average salivary flow rate 10th day after the end of LLLT)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
52 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients suffering from hyposalivation, with medical histories free of radiotherapy and Sjögren's syndrome Exclusion Criteria: medical histories of radiotherapy and Sjögren's syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Božana Lončar Brzak, Assist.Prof.
Organizational Affiliation
School of Dental Medicine, University of Zagreb
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dental Medicine, University of Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21054200
Citation
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.
Results Reference
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Low Level Laser Therapy for Hyposalivation

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