Antunes, H.S., Ferreira, E.M., de Matos, V.D., Pinheiro, C.T., & Ferreira, C.G. (2008). The impact of low power laser in the treatment of conditioning-induced oral mucositis: A report of 11 clinical cases and their review. Medicina Oral, Patología Oral y Cirugía Bucal, 13(3), 189–192.

Study Purpose

Low-power laser therapy (LPLT) versus placebo

Intervention Characteristics/Basic Study Process

Only dentists knew the randomization.

Low level intensity laser: InGaAIP diode laser—660 nm, 46.7 mW

Predental care

Oral care: Extrasoft toothbrushes; dental paste with a peroxidase system after meals, and alcohol-free chlorhexidine solution until neutrophil recovery TID

Evaluations were performed daily by one dentist (not blinded) and three nurses (blinded).

Crossover allowed for control group patients who developed grade 4 oral mucositis.
 

Sample Characteristics

The sample was comprised of 38 patients with HSCT.

Adults M =36.5/36.8

Women = 7/8
Men = 12/11

Autologous HSCT = 5/5

Allogenic HSCT = 14/14
 

Setting

Centro de Transplante de Medula Ossea

January 2004-May 2005

Study Design

Randomized, placebo-controlled, quantity and prospective clinical trial

Measurement Instruments/Methods

WHO scale

OMAS

VAS
 

Results

All patients completed the study; none were lost to follow-up or excluded.

LPLT less intense oral mucositis
Grade 0 = 1, 63.2%, 12 of 19 versus 10.5%, 2 of 19 (p < 0.001)

6 LPLT, 31.5% WHO Grade 2

94.7% WHO 0–2

Control group was the opposite (data not provided) (p < 0.001).

Mucositis-free survival hazard ration grade 2, 3, and 4 was 0.41 (p = 0.002); the hazard ration grade for grade 3 and 4 was 0.07.

OMAS = 84.2% (16) patients receiving laser treatment stayed on a weighted average zone of 0–2.9 versus 26.3% (5) (p = 0.007).

Patients receiving laser treatment presented with small extension of ulcerous area (p = 0.003).

Control group showed mucositis earlier (D + 5) than laser group (D + 6) (p = 0.67, NS).

Longer duration 6 versus 9 (p = 0.13, NS)

Longer to heal (p = 0.15)
 

Limitations

No differences in presence and intensity of pain

No differences in blood cultures

The level of agreement among evaluators was 81.7%.

Sample size

Implies difference when p value is not significant

Narrative frequently does not match p values.