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
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 45
- 主要终点
- Oral Mucositis Incidence
研究概览
简要总结
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
-
- to the day of discharge (day 28). The absolute neutrophil count, platelet counts and salivary flow rate of all patients was recorded.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient age greater than 16 years and less than 3 years.
- •Previous radiotherapy
- •Had more than one graft.
研究组 & 干预措施
Control
0.02% Chlorohexidine Gluconate: Mouth Rinse, 5ml, qid 3% Sodium Bicarbonate, Mouth Rinse, 5ml, qid Nystatin 10000U/ml : Mouth rinse, 5ml, qid
干预措施: .02% Chlorohexidine Gluconate (Drug)
Control
0.02% Chlorohexidine Gluconate: Mouth Rinse, 5ml, qid 3% Sodium Bicarbonate, Mouth Rinse, 5ml, qid Nystatin 10000U/ml : Mouth rinse, 5ml, qid
干预措施: 3% Sodium Bicarbonate (Drug)
Control
0.02% Chlorohexidine Gluconate: Mouth Rinse, 5ml, qid 3% Sodium Bicarbonate, Mouth Rinse, 5ml, qid Nystatin 10000U/ml : Mouth rinse, 5ml, qid
干预措施: Nystatin 10000U/ml (Drug)
Group 1
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
干预措施: .02% Chlorohexidine Gluconate (Drug)
Group 1
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
干预措施: 3% Sodium Bicarbonate (Drug)
Group 1
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
干预措施: Nystatin 10000U/ml (Drug)
Group 1
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
干预措施: Extra Soft Toothbrush (Device)
Group 2
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
干预措施: .02% Chlorohexidine Gluconate (Drug)
Group 2
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
干预措施: 3% Sodium Bicarbonate (Drug)
Group 2
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
干预措施: Nystatin 10000U/ml (Drug)
Group 2
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
干预措施: Supersaturated Calcium Phosphate (Drug)
结局指标
主要结局
Oral Mucositis Incidence
时间窗: 28 days
Presence of Oral Mucositis
次要结局
- Oral Mucositis Severity(28 Days)
研究者
Sarah Ali Mubaraki
Post Graduate in Pediatric Dentistry
Riyadh Colleges of Dentistry and Pharmacy