Clinical trial · Interventional
Laser vs Ozone Therapy for Oral Mucositis in Cancer Patients
Efficacy of Laser Therapy and Ozone Therapy for the Treatment of Oral Mucositis in Cancer Patients: A Randomized Clinical Trial
- 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)
This randomized clinical trial aims to compare the efficacy of laser therapy and ozone therapy in the treatment of oral mucositis in adult cancer patients undergoing chemotherapy or radiotherapy, particularly those with head and neck tumors or hematologic malignancies. Oral mucositis is a frequent and debilitating complication of cancer treatment, characterized by painful ulcerations that impair nutrition, speech, and oral hygiene, often requiring opioid analgesics and supportive care. Forty eligible patients will be randomly assigned to two parallel groups. The trial group will receive high-power diode laser therapy using a flat-top handpiece at 660 nm wavelength, following a standardized photobiomodulation protocol. The control group will be treated with medical ozone gas administered via an intraoral device, using a standardized ozone therapy protocol. Both treatments will be applied once daily over five consecutive days. Patients will be followed up at 15 and 30 days after treatment initiation. The primary outcome is the reduction in mucositis severity, measured using the World Health Organization (WHO) Oral Toxicity Scale. Secondary outcomes include pain intensity assessed with the Visual Analogue Scale (VAS), and quality of life evaluated through the Oral Mucositis Weekly Questionnaire - Head and Neck (OMWQ-HN). The study seeks to determine whether laser therapy offers superior clinical benefits compared to ozone therapy in reducing lesion severity, alleviating pain, and improving patient well-being during cancer treatment.
Conditions
Conditions (3)
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 Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laser Therapy | Device | — | UNRESOLVED |
| Ozone therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laser Therapy for Oral Mucositis
- description
- Patients in this arm will undergo high-power diode laser therapy using the Garda Laser LEO PLUS device with a flat-top handpiece at a wavelength of 660 nm. The laser is applied intraorally on the mucosal lesions following a standardized photobiomodulation protocol. The treatment is administered once daily for five consecutive days. Mucositis severity (WHO scale), pain intensity (VAS), and quality of life (OMWQ-HN) will be monitored from baseline through 30 days of follow-up.
- interventionNames
- Device: Laser Therapy
- type
- ACTIVE_COMPARATOR
- label
- Ozone Therapy for Oral Mucositis
- description
- Patients in this arm will receive medical ozone therapy for the treatment of chemotherapy- or radiotherapy-induced oral mucositis. Ozone is administered intraorally in gaseous form using a Sweden \& Martina DTA device and a flat probe specifically designed for mucosal application. The treatment is delivered once daily for five consecutive days, following a standardized therapeutic protocol. Clinical parameters including mucositis severity (WHO scale), pain (VAS), and quality of life (OMWQ-HN) will be assessed at baseline and during follow-up.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Diagnosis of head and neck cancer or hematologic malignancy * Currently undergoing chemotherapy and/or radiotherapy * Presence of oral mucositis of grade 2 or higher (WHO Oral Mucositis Scale) * Ability to provide written informed consent * Willingness to comply with study procedures and follow-up schedule Exclusion Criteria: * Presence of autoimmune or systemic diseases affecting the oral mucosa (e.g., lichen planus, pemphigus, pemphigoid) * Presence of active oral infections unrelated to mucositis (e.g., candidiasis, herpes simplex) * Previous treatment with ozone or laser therapy for oral mucositis in the past 3 months * Pregnancy or breastfeeding * Cognitive impairment or psychiatric disorders preventing full cooperation * Known allergy or intolerance to ozone or laser exposure * Use of investigational drugs or participation in other clinical trials within 30 days prior to enrollment
References
Publications (0)
Data not yet available