Clinical trial NCT03049943: Low Level Laser Therapy for Hyposalivation
Official title: Different Low Level Laser Protocols for Therapy of Hyposalivation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyposalivation
Keywords: low level laser therapy
hyposalivation
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2017-02-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 52
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference in average salivary flow rate, before and after low level laser treatment
timeFrame: 10 days
Secondary outcomes:
measure: Average salivary flow rate
timeFrame: 1 day (Average salivary flow rate 10th day after the end of LLLT)
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: School of Dental Medicine, University of Zagreb
Study officials:
affiliation: School of Dental Medicine, University of Zagreb
name: Božana Lončar Brzak, Assist.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.