Clinical trial · Interventional
The Management of RT-induced Hyposalivation Using LLLT
The Management of Radiotherapy-induced Hyposalivation Using Low-level Laser Therapy: A Case Series.
NCT05538169CI-TRIAL-00070689REACH-LLLTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| low-level laser diode (Pioon Laser) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Laser therapy group
- description
- 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
- interventionNames
- Device: low-level laser diode (Pioon Laser)
Primary outcomes (1)
- measure
- Unstimulated and stimulated salivary flow rate
- timeFrame
- 12 weeks
- description
- 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.
Secondary outcomes (3)
- measure
- Xerostomia assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDAlsoghier 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