Low Level Laser Therapy for Hyposalivation

NCT ID: NCT03049943

Last Updated: 2017-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-05

Study Completion Date

2014-09-16

Brief Summary

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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

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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.

Conditions

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Hyposalivation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Laser wavelength of 830 nm

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.

Group Type ACTIVE_COMPARATOR

low level laser

Intervention Type DEVICE

Laser wavelength of 685 nm

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.

Group Type EXPERIMENTAL

low level laser

Intervention Type DEVICE

Interventions

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low level laser

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

52 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zagreb

OTHER

Sponsor Role lead

Responsible Party

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Božana Lončar Brzak

Assisstant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Božana Lončar Brzak, Assist.Prof.

Role: PRINCIPAL_INVESTIGATOR

School of Dental Medicine, University of Zagreb

Locations

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School of Dental Medicine, University of Zagreb

Zagreb, , Croatia

Site Status

Countries

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Croatia

References

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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.

Reference Type RESULT
PMID: 21054200 (View on PubMed)

Other Identifiers

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05/05/2012

Identifier Type: -

Identifier Source: org_study_id

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