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Oral Hygiene Regimen in Patients on HCT

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ClinicalTrials.gov Identifier: NCT02662374
Recruitment Status : Unknown
Verified January 2016 by Sarah Ali Mubaraki, Riyadh Colleges of Dentistry and Pharmacy.
Recruitment status was:  Enrolling by invitation
First Posted : January 25, 2016
Last Update Posted : January 25, 2016
Sponsor:
Collaborator:
King Faisal Specialist Hospital & Research Center
Information provided by (Responsible Party):
Sarah Ali Mubaraki, Riyadh Colleges of Dentistry and Pharmacy

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Oral Mucositis Drug: .02% Chlorohexidine Gluconate Drug: 3% Sodium Bicarbonate Drug: Nystatin 10000U/ml Device: Extra Soft Toothbrush Drug: Supersaturated Calcium Phosphate Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Study Start Date : September 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Active Comparator: Control
0.02% Chlorohexidine Gluconate: Mouth Rinse, 5ml, qid 3% Sodium Bicarbonate, Mouth Rinse, 5ml, qid Nystatin 10000U/ml : Mouth rinse, 5ml, qid
Drug: .02% Chlorohexidine Gluconate
5ml of the drug in mouthwash form to be swished four times a day
Other Name: Clorasept (ArRiyadh Pharmaceuticals, Riyadh, Saudi Arabia)

Drug: 3% Sodium Bicarbonate
5ml of the drug in the form of a prepared solution to be swished four times a day
Other Name: 3% Na2CO3

Drug: Nystatin 10000U/ml
5ml of the drug in mouthwash form to be swished and swallowed four times a day
Other Name: Mycostatin (Amman Pharmacuetical Corp. Amman, Jordan

Experimental: 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
Drug: .02% Chlorohexidine Gluconate
5ml of the drug in mouthwash form to be swished four times a day
Other Name: Clorasept (ArRiyadh Pharmaceuticals, Riyadh, Saudi Arabia)

Drug: 3% Sodium Bicarbonate
5ml of the drug in the form of a prepared solution to be swished four times a day
Other Name: 3% Na2CO3

Drug: Nystatin 10000U/ml
5ml of the drug in mouthwash form to be swished and swallowed four times a day
Other Name: Mycostatin (Amman Pharmacuetical Corp. Amman, Jordan

Device: Extra Soft Toothbrush
To be moistened with 0.9% normal Saline and used twice daily to remove dental plaque

Experimental: 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
Drug: .02% Chlorohexidine Gluconate
5ml of the drug in mouthwash form to be swished four times a day
Other Name: Clorasept (ArRiyadh Pharmaceuticals, Riyadh, Saudi Arabia)

Drug: 3% Sodium Bicarbonate
5ml of the drug in the form of a prepared solution to be swished four times a day
Other Name: 3% Na2CO3

Drug: Nystatin 10000U/ml
5ml of the drug in mouthwash form to be swished and swallowed four times a day
Other Name: Mycostatin (Amman Pharmacuetical Corp. Amman, Jordan

Drug: Supersaturated Calcium Phosphate
5ml of the solution to be swished four times a day
Other Name: Moistir (Kingswood laboratories Inc., Indianapolis IN USA)




Primary Outcome Measures :
  1. Oral Mucositis Incidence [ Time Frame: 28 days ]
    Presence of Oral Mucositis


Secondary Outcome Measures :
  1. Oral Mucositis Severity [ Time Frame: 28 Days ]
    Severity of Oral Mucositis measured using WHO criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662374


Sponsors and Collaborators
Riyadh Colleges of Dentistry and Pharmacy
King Faisal Specialist Hospital & Research Center
Investigators
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Study Director: abdullah R alshammery, PhD RiyadhCPD

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Responsible Party: Sarah Ali Mubaraki, Post Graduate in Pediatric Dentistry, Riyadh Colleges of Dentistry and Pharmacy
ClinicalTrials.gov Identifier: NCT02662374     History of Changes
Other Study ID Numbers: RiyadhCDP
First Posted: January 25, 2016    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Nystatin
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action