Clinical trial · Interventional
Oral Mucositis and Laser Therapy Associated With Photodynamic Therapy
Laser Therapy Associated With Photodynamic Therapy in the Treatment of Oral Mucositis Induced by Chemotherapy in Young Patients: Randomized Blind 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)
The aim of the study was to evaluate the therapeutic action through the diameter of the lesion, of low level laser (LLL) associated to photodynamic therapy (PDT) in oral mucositis (OM) lesions, in young patients. A randomized clinical trial blinded, split-mouth was performed. The study sample consisted of 15 cancer patients (3-16 years old) of Aldenora Bello Hospital (São Luís, Maranhão, Brazil). Random allocation by lot of treatments (PDT + LLL and LLL) to quadrants of the oral cavity was performed, and the patient was his own control. Patients were masked about therapy performed on each side of the arch. The evaluation period of both therapeutic regimens was 8 days, and the outcome assessed was the lesion size (measured in cm²). Friedman and Wilcoxon tests were applied and the effect magnitude calculated. The significance level was 5%. Statistically significant difference was observed between the groups for the lesion diameter of the 6th to the 8th day (greater regression of lesion size for the PDT + LLL group), which was confirmed by a difference magnitude moderated. Based on the findings, it is concluded that PDT + LLL showed greater therapeutic effect when compared to LLL in reducing the severity of OM lesions.
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 |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low level laser | Radiation | — | UNRESOLVED |
| PDT + Low level laser | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PDT + Low level laser
- description
- PDT (photosensitizer and low level laser) and low level laser Photosensitizer: aqueous solution of 0.005% methylene blue; Low level laser: infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium) and red emitter with active medium InGaAlP (phosphide and Indium, Gallium and Potassium)
- interventionNames
- Other: PDT + Low level laser
- type
- ACTIVE_COMPARATOR
- label
- Low level laser
- description
- Low level laser: infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium) and red emitter with active medium InGaAlP (phosphide and Indium, Gallium and Potassium)
- interventionNames
- Radiation: Low level laser
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients between 3 and 18 years old * Patients on chemotherapy inductive phase * Patients with oral mucositis and bilateral lesions Exclusion Criteria: * Patients outside the established age * Patients who are in other phases of chemotherapy * Patients who did not have bilateral lesions
References
Publications (36)
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- BACKGROUNDAndrade MC, Ribeiro AP, Dovigo LN, Brunetti IL, Giampaolo ET, Bagnato VS, Pavarina AC. Effect of different pre-irradiation times on curcumin-mediated photodynamic therapy against planktonic cultures and biofilms of Candida spp. Arch Oral Biol. 2013 Feb;58(2):200-10. doi: 10.1016/j.archoralbio.2012.10.011. Epub 2012 Nov 13. PMID 23153629
- BACKGROUNDLee YH, Park HW, Lee JH, Seo HW, Lee SY. The photodynamic therapy on Streptococcus mutans biofilms using erythrosine and dental halogen curing unit. Int J Oral Sci. 2012 Dec;4(4):196-201. doi: 10.1038/ijos.2012.63. Epub 2012 Dec 7. PMID 23222991
- BACKGROUNDMattiello FD, Coelho AA, Martins OP, Mattiello RD, Ferrao Junior JP. In vitro effect of photodynamic therapy on aggregatibacter actinomycetemcomitans and Streptococcus sanguinis. Braz Dent J. 2011;22(5):398-403. doi: 10.1590/s0103-64402011000500009.