Trial Outcomes & Findings for Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome (NCT NCT02066896)

Results Overview

The Xerostomia Inventory (XI) is an 11-item questionnaire (Thomson et al, 1999). Scores to the 11 items are summated, providing a single score (5-55) representing the subjective severity of xerostomia. In 2012, da Mata published a validated version in portuguese and we used this version. The better score is the lowest. The significant variation is defined as 6 or more. Bellow we describe all the 11 questions: 1. I sip liquids to aid in swallowing food 2. My mouth feels dry when eating a meal 3. I get up at night to drink 4. My mouth feels dry 5. I have difficulty in eating dry foods 6. I suck sweets or cough lollies to relieve dry mouth 7. I have difficulties swallowing certain foods 8. The skin of my face feels dry 9. My eyes feel dry 10. My lips feel dry 11. The inside of my nose feels dry \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Score: Never' (1), Hardly ever' (2), Occasionally' (3), Fairly often' (4), Very often' (5)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

6 weeks

Results posted on

2017-08-03

Participant Flow

The study sample consisted of 66 patients who were selected from 84 patients referred from ophthalmology and rheumatology division of university hospital. The patients met primary Sjögren's criteria (2002).

The exclusion criteria were: sarcoidosis, uncontrolled thyroidopathy, HIV and HCV infections and head or neck irradiation history. A computer-generated randomization list was used to allocate patients ramdomly into two groups: active laser therapy and sham laser therapy. Concealed randomization was performed with opaque sealed envelopes.

Participant milestones

Participant milestones
Measure	Sham Comparator: Sham Lasertherapy Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks. Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group).	Active Comparator: Lasertherapy Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks. Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)
Overall Study STARTED	33	33
Overall Study COMPLETED	33	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham Comparator: Sham Lasertherapy n=33 Participants Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks. Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group).	Active Comparator: Lasertherapy n=33 Participants Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks. Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)	Total n=66 Participants Total of all reporting groups
Age, Continuous	58 years (SD) STANDARD_DEVIATION 11.1 • n=33 Participants	54 years (SD) STANDARD_DEVIATION 11.3 • n=33 Participants	57 years (SD) STANDARD_DEVIATION 11.0 • n=66 Participants
Sex: Female, Male Female	32 Participants n=33 Participants	32 Participants n=33 Participants	64 Participants n=66 Participants
Sex: Female, Male Male	1 Participants n=33 Participants	1 Participants n=33 Participants	2 Participants n=66 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Brazil	33 participants n=33 Participants	33 participants n=33 Participants	66 participants n=66 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Intent to treat population. Last observation carried forward imputation method.

The Xerostomia Inventory (XI) is an 11-item questionnaire (Thomson et al, 1999). Scores to the 11 items are summated, providing a single score (5-55) representing the subjective severity of xerostomia. In 2012, da Mata published a validated version in portuguese and we used this version. The better score is the lowest. The significant variation is defined as 6 or more. Bellow we describe all the 11 questions: 1. I sip liquids to aid in swallowing food 2. My mouth feels dry when eating a meal 3. I get up at night to drink 4. My mouth feels dry 5. I have difficulty in eating dry foods 6. I suck sweets or cough lollies to relieve dry mouth 7. I have difficulties swallowing certain foods 8. The skin of my face feels dry 9. My eyes feel dry 10. My lips feel dry 11. The inside of my nose feels dry \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Score: Never' (1), Hardly ever' (2), Occasionally' (3), Fairly often' (4), Very often' (5)

Outcome measures

Outcome measures
Measure	Sham Comparator: Sham Lasertherapy n=33 Participants Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks. Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group).	Active Comparator: Lasertherapy n=33 Participants Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks. Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)
The Xerostomia Inventory	40.2 units on a scale Standard Deviation 8.3	39.3 units on a scale Standard Deviation 8.1

SECONDARY outcome

Timeframe: 6 weeks

The saliva in Sögren's syndrome patients has a high level of beta 2 microglobulin reflecting progression of the disease and inflammatory process at glandular epithelium. The saliva samples were collected at the baseline and end point. Beta 2 microglobulin was determined by Elisa human kit (ABCAM ab 108885). The normal levels are 1,2 +/- 0,7 microg/ml, and for primary Sjögren's syndrome 5,3 +/- 4,6 microg/ml. This measure was done in the samples of saliva before and after the lasertherapy for all patients.

Outcome measures

Outcome measures
Measure	Sham Comparator: Sham Lasertherapy n=33 Participants Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks. Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group).	Active Comparator: Lasertherapy n=33 Participants Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks. Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)
Salivary Biomarker Analysis. Beta 2 Microglobulin.	1.10 microg/ml Standard Deviation 3.63	0.84 microg/ml Standard Deviation 4.93

SECONDARY outcome

Timeframe: 6 weeks

The salivary flux was measured at the same time, without previous meal or tooth brushing, drinking or eating, in a quiet room. Spilled saliva was collected in a graduated Falcon 15ml tube. The samples of saliva were frozen and stored at -20° C. Normal salivary stimulated flux is above 0,5 ml/min. Normal unstimulated salivary flux is above 0,2 ml/min.

Outcome measures

Outcome measures
Measure	Sham Comparator: Sham Lasertherapy n=33 Participants Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks. Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group).	Active Comparator: Lasertherapy n=33 Participants Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks. Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)
Salivary Flux Measurement	0.100 ml/min Standard Deviation 0.164	0.100 ml/min Standard Deviation 0.114

Adverse Events

Sham Comparator: Sham Lasertherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Comparator: Lasertherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tania Sales de Alencar Fidelix

Federal University of Sao Paulo

Phone: 11991346992

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place