Oral Mucositis Clinical Trial
Official title:
Efficacy of Two Different Oral Hygiene Regimens on the Incidence and Severity of Oral Mucositis in Patients Receiving Hematopoietic Stem Cell Transplantation - A Randomized Controlled Trial
Oral mucositis is one of the most common debilitating forms of mucositis that arise from
high dose chemotherapy and radiotherapy. It is reported that almost 75% patients undergoing
hematopoietic cell transplantation (HCT) develop oral mucositis at different levels of
severity. The objective of this prospective study was to assess the efficacy of the addition
of supersaturated calcium phosphate oral spray and the addition of an extra soft tooth brush
to the basic OH in addition to the currently existing oral hygiene protocol regimen (0.2%
Chlorhexidine Gluconate + 3% Sodium Bicarbonate+ Nystatin 100000 U/ml) in reducing the
severity of oral mucositis among patients receiving chemotherapy for HCT.
60 patients receiving chemotherapy for HCT were randomly allocated to four groups of 15
patients each The oral mucositis was recorded according to WHO criteria and the progression
of the oral mucositis was monitored from the day of admission (day
- 1) to the day of discharge (day 28). The absolute neutrophil count, platelet counts and
salivary flow rate of all patients was recorded.
This study will be prospective randomized case controlled study
Oral mucositis and oral hygiene protocol intervention:
45 patients admitted at King Faisal specialist hospital and Research Center in Riyadh for
HCT and receiving chemotherapy regimen will be observed for the incidence and severity of
oral mucositis.
Inclusion criteria:
- 3 to 16 years patients
- Male and female
- Allogeneic transplant
- Patient receiving conditioning regime
- CYTOXAN, ATG, FLUDARABINE
- BUSULPHAN/CYTOXAN/ATG WITH MTX
- BUSULPHAN/CYTOXAN WITH MTX
- FLUDARABINE/BUSULPHAN
Exclusion criteria:
- Patient age greater than 16 years and less than 3 years.
- Previous radiotherapy
- Had more than one graft.
Data Collection The child's age, gender, living area, type of disease, conditioning
treatment protocol, absolute neutrophil count level, platelet count, use of opiate
analgesics and patient reported outcome (pain, ability to eat, saliva flow rate and it is
thickness) will be recorded.
Each patient will be examined once daily until discharge using the WHO criteria (see
appendix I) At day -1
- All patient will receive an oral examination before chemo regimen or HCT started using
the WHO oral health assessment form and the OM form as baseline for each patient.
- Start of the oral health protocol
Day 0, day 5, day10, day20, and day 25 Examination by tongue depressor and penlight to fill
the OM form only and application of the oral hygiene protocol.
Oral health care protocol (OHCP):
Patients who fit the inclusion criteria will be randomly assigned to one of the following
three groups Control group (15 patient) The control group will receive oral hygiene using
the following protocol
- Chlorhexidine gluconate as a mouth wash 4 times daily
- Sodium bicarbonate mouth wash 4 times daily
- Patient can rinse by sterile water any time
- Nystatin will be administered 4 times.
Test group1 (15 patient)
- Twice a day oral prophylaxis by extra soft brush and water
- Chlorhexidine gluconate as a mouth wash 4 times daily
- Sodium bicarbonate mouth wash 4 times daily
- Patient can rinse by sterile water any time
- Nystatin will be administered 4 times.
Test group 2(15 patient)
- Supersaturated Calcium Spray 4 times daily
- Chlorhexidine gluconate as a mouth wash 4 times daily
- Sodium bicarbonate mouth wash 4 times daily
- Patient can rinse by sterile water any time
- Nystatin will be administered 4 times.
Test group 3(15 patient)
- Twice a day oral prophylaxis by extra soft brush and water Supersaturated Calcium Spray
4 times daily.
- Chlorhexidine gluconate as a mouth wash 4 times daily
- Sodium bicarbonate mouth wash 4 times daily
- Patient can rinse by sterile water any time
- Nystatin will be administered 4 times.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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