Low Level Laser Therapy for Hyposalivation

Hyposalivation Clinical Trial

Official title:

Different Low Level Laser Protocols for Therapy of Hyposalivation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03049943
• Other study ID #: 05/05/2012
• Status: Completed
• Phase: N/A
• First received: February 3, 2017
• Last updated: February 9, 2017
• Start date: May 5, 2014
• Est. completion date: September 16, 2014

Study information

• Verified date: February 2017
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 16, 2014
• Est. primary completion date: September 16, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 52 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyposalivation

Intervention

Device:
• low level laser

Locations

Country	Name	City	State
Croatia	School of Dental Medicine, University of Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)