search
Back to results

Oral Hygiene Regimen in Patients on HCT

Primary Purpose

Oral Mucositis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
.02% Chlorohexidine Gluconate
3% Sodium Bicarbonate
Nystatin 10000U/ml
Extra Soft Toothbrush
Supersaturated Calcium Phosphate
Sponsored by
Riyadh Colleges of Dentistry and Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Mucositis

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Control

    Group 1

    Group 2

    Arm Description

    0.02% Chlorohexidine Gluconate: Mouth Rinse, 5ml, qid 3% Sodium Bicarbonate, Mouth Rinse, 5ml, qid Nystatin 10000U/ml : Mouth rinse, 5ml, qid

    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

    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

    Outcomes

    Primary Outcome Measures

    Oral Mucositis Incidence
    Presence of Oral Mucositis

    Secondary Outcome Measures

    Oral Mucositis Severity
    Severity of Oral Mucositis measured using WHO criteria

    Full Information

    First Posted
    January 19, 2016
    Last Updated
    January 21, 2016
    Sponsor
    Riyadh Colleges of Dentistry and Pharmacy
    Collaborators
    King Faisal Specialist Hospital & Research Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02662374
    Brief Title
    Oral Hygiene Regimen in Patients on HCT
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    April 2016 (Anticipated)
    Study Completion Date
    May 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Riyadh Colleges of Dentistry and Pharmacy
    Collaborators
    King Faisal Specialist Hospital & Research Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Mucositis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    0.02% Chlorohexidine Gluconate: Mouth Rinse, 5ml, qid 3% Sodium Bicarbonate, Mouth Rinse, 5ml, qid Nystatin 10000U/ml : Mouth rinse, 5ml, qid
    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Group 2
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    .02% Chlorohexidine Gluconate
    Other Intervention Name(s)
    Clorasept (ArRiyadh Pharmaceuticals, Riyadh, Saudi Arabia)
    Intervention Description
    5ml of the drug in mouthwash form to be swished four times a day
    Intervention Type
    Drug
    Intervention Name(s)
    3% Sodium Bicarbonate
    Other Intervention Name(s)
    3% Na2CO3
    Intervention Description
    5ml of the drug in the form of a prepared solution to be swished four times a day
    Intervention Type
    Drug
    Intervention Name(s)
    Nystatin 10000U/ml
    Other Intervention Name(s)
    Mycostatin (Amman Pharmacuetical Corp. Amman, Jordan
    Intervention Description
    5ml of the drug in mouthwash form to be swished and swallowed four times a day
    Intervention Type
    Device
    Intervention Name(s)
    Extra Soft Toothbrush
    Intervention Description
    To be moistened with 0.9% normal Saline and used twice daily to remove dental plaque
    Intervention Type
    Drug
    Intervention Name(s)
    Supersaturated Calcium Phosphate
    Other Intervention Name(s)
    Moistir (Kingswood laboratories Inc., Indianapolis IN USA)
    Intervention Description
    5ml of the solution to be swished four times a day
    Primary Outcome Measure Information:
    Title
    Oral Mucositis Incidence
    Description
    Presence of Oral Mucositis
    Time Frame
    28 days
    Secondary Outcome Measure Information:
    Title
    Oral Mucositis Severity
    Description
    Severity of Oral Mucositis measured using WHO criteria
    Time Frame
    28 Days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    abdullah R alshammery, PhD
    Organizational Affiliation
    RiyadhCPD
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Oral Hygiene Regimen in Patients on HCT

    We'll reach out to this number within 24 hrs