Low Level Laser Therapy for Hyposalivation

Not Applicable

Completed

• Conditions: Hyposalivation
• Interventions: Device: low level laser

• Registration Number: NCT03049943
• Lead Sponsor: University of Zagreb

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.

Study Timeline

• Study Start: 2014-05-05
• Primary Completion: 2014-09-16
• Study Completion: 2014-09-16
• Status Verified: 2017-02
• Study First Submitted: 2017-02-03
• Study First Submitted QC: 2017-02-09
• Last Update Submitted: 2017-02-09
• Study First Posted: 2017-02-10
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser wavelength of 685 nm	low level laser	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.
Laser wavelength of 830 nm	low level laser	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.

Primary Outcome Measures

Name	Time	Method
Difference in average salivary flow rate, before and after low level laser treatment	10 days	The whole unstimulated and stimulated saliva was measured each day during 10 days, before and after laser treatment

Secondary Outcome Measures

Name	Time	Method
Average salivary flow rate	1 day (Average salivary flow rate 10th day after the end of LLLT)	Average salivary flow rate 10th day after the end of LLLT

Trial Locations

Locations (1)

School of Dental Medicine, University of Zagreb; 🇭🇷 Zagreb, Croatia