Low Level Laser Therapy for Hyposalivation

NCT03049943 | Completed DMC

• 1 other identifier: 05/05/2012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyposalivation

Keywords

low level laser therapy; hyposalivation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Average salivary flow rate

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

Study Arms (2)

Laser wavelength of 830 nm

ACTIVE COMPARATOR

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

Laser wavelength of 685 nm

EXPERIMENTAL

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

Interventions

low level laser DEVICE

Laser wavelength of 685 nm; Laser wavelength of 830 nm

Eligibility Criteria

• Age: 52 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• medical histories of radiotherapy and Sjögren's syndrome

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

School of Dental Medicine, University of Zagreb

Zagreb, 10000, Croatia

Location

Related 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. Epub 2010 Nov 6.

  PMID: 21054200 RESULT

MeSH Terms

Conditions

Xerostomia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Božana Lončar Brzak, Assist.Prof.

  School of Dental Medicine, University of Zagreb

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 10, 2017
• Study Start: May 5, 2014
• Primary Completion: September 16, 2014
• Study Completion: September 16, 2014
• Last Updated: February 10, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)