Low Level Laser Therapy for Hyposalivation

Study Overview
=================
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.

Official Title
-----------------
Different Low Level Laser Protocols for Therapy of Hyposalivation

Conditions
-----------------
Hyposalivation

Intervention / Treatment
-----------------
* Device: low level laser


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 52 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laser wavelength of 830 nm<br>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. | Device: low level laser<br> <br> |
| Experimental: Laser wavelength of 685 nm<br>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. | Device: low level laser<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average salivary flow rate | Average salivary flow rate 10th day after the end of LLLT | 1 day (Average salivary flow rate 10th day after the end of LLLT) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low level laser therapy, hyposalivation