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| Name | Class |
|---|---|
| King Faisal Specialist Hospital & Research Center | OTHER |
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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
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
Exclusion criteria:
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
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
Test group1 (15 patient)
Test group 2(15 patient)
Test group 3(15 patient)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | 0.02% Chlorohexidine Gluconate: Mouth Rinse, 5ml, qid 3% Sodium Bicarbonate, Mouth Rinse, 5ml, qid Nystatin 10000U/ml : Mouth rinse, 5ml, qid |
|
| Group 1 | Experimental | 0.02% Chlorohexidine Gluconate: Mouth Rinse, 5ml, qid 3% Sodium Bicarbonate, Mouth Rinse, 5ml, qid Nystatin 10000U/ml : Mouth rinse, 5ml, qid Extra soft toothbrush, brushing with saline bd |
|
| Group 2 | Experimental | 0.02% Chlorohexidine Gluconate: Mouth Rinse, 5ml, qid 3% Sodium Bicarbonate, Mouth Rinse, 5ml, qid Nystatin 10000U/ml : Mouth rinse, 5ml, qid Supersaturated Calcium Phosphate Spray, 5ml qid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| .02% Chlorohexidine Gluconate | Drug | 5ml of the drug in mouthwash form to be swished four times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oral Mucositis Incidence | Presence of Oral Mucositis | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Mucositis Severity | Severity of Oral Mucositis measured using WHO criteria | 28 Days |
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Inclusion Criteria:
3 to 16 years patients
Male and female
Allogeneic transplant
Patient receiving conditioning regime
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| abdullah R alshammery, PhD | RiyadhCPD | Study Director |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D009761 | Nystatin |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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| 3% Sodium Bicarbonate | Drug | 5ml of the drug in the form of a prepared solution to be swished four times a day |
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| Nystatin 10000U/ml | Drug | 5ml of the drug in mouthwash form to be swished and swallowed four times a day |
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| Extra Soft Toothbrush | Device | To be moistened with 0.9% normal Saline and used twice daily to remove dental plaque |
|
| Supersaturated Calcium Phosphate | Drug | 5ml of the solution to be swished four times a day |
|
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| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |