Papas, A.S., Clark, R.E., Martuscelli, G., O’Loughlin, K.T., Johansen, E., & Miller, K.B. (2003). A prospective, randomized trial for the prevention of mucositis in patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplantation, 31, 705–712.

Patients rinsed with 30 ml of calcium phosphate at least four times per day. Patients also received four topical treatments of 1% fluoride as neutral 2% sodium fluoride gel administered by tray at the screening visit and completed prior to hospitalization.

Patients in the control group received an aqueous 0.01% sodium fluoride rinse. Prior to transplantation, the control group received four topical treatments with a placebo gel administered with the same technique as the experimental group. During transplantation, patients used the sodium fluoride rinse at least four times daily, 30 ml each time.

Patients who developed severe mucositis were instructed to rinse up to 10 times per day with their solution.

All patients received acyclovir and antifungal prophylaxis per protocol.

• The study reported on 95 patients undergoing hematopoietic stem cell transplantation (HSCT).
• Patients receiving autologous HSCT had peripheral stem cells and granulocyte colony-stimulating factor (G-CSF).
• Patients receiving allogenic HSCT had bone marrow cells and methotrexate (MTX).
• The experimental group had 50 patients, and the control group had 47 patients.

This was a randomized, controlled trial.

The National Institute of Dental and Craniofacial Research scale was used.

The following were measured and recorded.

• Days to absolute neutorphile count (ANC) greater than 200 mm³
• Days to ANC greater than 500 mm³
• Days of mucositis
• Peak mucositis level
• Peak pain level
• Days of pain
• Milligrams of self-administered morphine
• Days of morphine
• Average length of stay (ALOS)

• Duration of mucositis was 7.2 days in the control group and 3.72 days in the caphosol group (p = 0.00096).
• The control group had a smaller percentage of patients experiencing no mucositis (19% versus 40%).
• Peak mucositis was significantly higher for the control group (p = 0.004).
• The experimental group experienced fewer days of pain, milligrams of morphine, and days of morphine.

• The study had an adequate sample size according to power analysis.
• Frequency, duration, and severity of oral inflammatory processes were significantly lower in the experimental group.

• Use of fluoride may have decreased infection.
• No comparison was provided between allogeneic and autologous transplantations and the presence of mucositis.