Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
45 participants
INTERVENTIONAL
2015-09-30
2016-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control
0.02% Chlorohexidine Gluconate: Mouth Rinse, 5ml, qid 3% Sodium Bicarbonate, Mouth Rinse, 5ml, qid Nystatin 10000U/ml : Mouth rinse, 5ml, qid
.02% Chlorohexidine Gluconate
5ml of the drug in mouthwash form to be swished four times a day
3% Sodium Bicarbonate
5ml of the drug in the form of a prepared solution to be swished four times a day
Nystatin 10000U/ml
5ml of the drug in mouthwash form to be swished and swallowed four times a day
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
.02% Chlorohexidine Gluconate
5ml of the drug in mouthwash form to be swished four times a day
3% Sodium Bicarbonate
5ml of the drug in the form of a prepared solution to be swished four times a day
Nystatin 10000U/ml
5ml of the drug in mouthwash form to be swished and swallowed four times a day
Extra Soft Toothbrush
To be moistened with 0.9% normal Saline and used twice daily to remove dental plaque
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
.02% Chlorohexidine Gluconate
5ml of the drug in mouthwash form to be swished four times a day
3% Sodium Bicarbonate
5ml of the drug in the form of a prepared solution to be swished four times a day
Nystatin 10000U/ml
5ml of the drug in mouthwash form to be swished and swallowed four times a day
Supersaturated Calcium Phosphate
5ml of the solution to be swished four times a day
Interventions
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.02% Chlorohexidine Gluconate
5ml of the drug in mouthwash form to be swished four times a day
3% Sodium Bicarbonate
5ml of the drug in the form of a prepared solution to be swished four times a day
Nystatin 10000U/ml
5ml of the drug in mouthwash form to be swished and swallowed four times a day
Extra Soft Toothbrush
To be moistened with 0.9% normal Saline and used twice daily to remove dental plaque
Supersaturated Calcium Phosphate
5ml of the solution to be swished four times a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Previous radiotherapy
* Had more than one graft.
3 Years
16 Years
ALL
No
Sponsors
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King Faisal Specialist Hospital & Research Center
OTHER
Riyadh Colleges of Dentistry and Pharmacy
OTHER
Responsible Party
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Sarah Ali Mubaraki
Post Graduate in Pediatric Dentistry
Principal Investigators
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abdullah R alshammery, PhD
Role: STUDY_DIRECTOR
RiyadhCPD
Other Identifiers
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RiyadhCDP
Identifier Type: -
Identifier Source: org_study_id
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