The Management of RT-induced Hyposalivation Using LLLT

NCT05538169 | Completed DMC

• 1 other identifier: KingSaudU-E-21-6045
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose is to evaluate the effectiveness of photobiomodulation laser application in the management of patients with radiotherapy-induced hyposalivation. Secondary, to assess the changes in the scores of the patient's oral health-related quality of life using validated measurements.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Unstimulated and stimulated salivary flow rate

  The unstimulated and stimulated salivary flow rate (ml/minute) will be collected at three different time periods: (T1) the first visit and before applying the laser, (T2) the 8th visit and after using the laser, and (T3) the re-evaluation visit after two months.

  12 weeks

Secondary Outcomes (3)

• Xerostomia assessment

  12 weeks

• Dysgeusia assessment

  12 weeks

• Quality of life assessment

  12 weeks

Study Arms (1)

Laser therapy group

EXPERIMENTAL

There will be 2 weekly applications of a low-level laser diode (Pioon Laser) for a 4-week active treatment period. Thus, a total of 8 therapeutic sessions will be conducted

Device: low-level laser diode (Pioon Laser)

Interventions

low-level laser diode (Pioon Laser) DEVICE

Settings: the spot tip area of this tool is 0.088 cm2, semi-conductor diode, with a wavelength of 980 nm (near infrared), 200 mW output power, 1.97W/cm2 of power density, 3 J energy per point and application time 15 seconds per point\]. * PBM will apply punctually, in continuous emissions. * Extra-oral points: six points on each parotid gland, three points on each submandibular gland. * Intra-oral points: two points on each sublingual gland. * A total of 22 points will be applied in each session.

Laser therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 and above
• Clinically diagnosed with hyposalivation \[an unstimulated salivary flow rate of ≤ 0.1ml per minute\] (31) due to recent radiation therapy of SCC of the head and neck.

You may not qualify if:

• Individuals with systemic diseases that could affect the salivary glands function such as (e.g. Sjogren syndrome) and medications (e.g. beta-blockers and diuretics for hypertension).
• Individuals who had an allergy to toluidine blue stain.

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud Universiry

Riyadh, 11472, Saudi Arabia

Location

Related Publications (1)

• Alsoghier A, Mutaieb S, Bukhari A, AlQarni M, Alhazzaa S, Aljabab S, Alsuhaibani A, Faden A. Management of radiotherapy-induced hyposalivation using photobiomodulation therapy: a case series. Lasers Med Sci. 2025 Jan 20;40(1):25. doi: 10.1007/s10103-025-04292-3.

  PMID: 39833441 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Oral Medicine

Model Details: A prospective case series of patients who have received radiotherapy for SCC of the head and neck

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: January 3, 2022
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

SA (1)