Oral Hygiene Regimen in Patients on HCT

January 21, 2016 updated by: Sarah Ali Mubaraki, Riyadh Colleges of Dentistry and Pharmacy

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 3% Na2CO3
Drug: Nystatin 10000U/ml
5ml of the drug in mouthwash form to be swished and swallowed four times a day
Other Names:
  • 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 Names:
  • 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 Names:
  • 3% Na2CO3
Drug: Nystatin 10000U/ml
5ml of the drug in mouthwash form to be swished and swallowed four times a day
Other Names:
  • 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 Names:
  • 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 Names:
  • 3% Na2CO3
Drug: Nystatin 10000U/ml
5ml of the drug in mouthwash form to be swished and swallowed four times a day
Other Names:
  • Mycostatin (Amman Pharmacuetical Corp. Amman, Jordan
Drug: Supersaturated Calcium Phosphate
5ml of the solution to be swished four times a day
Other Names:
  • Moistir (Kingswood laboratories Inc., Indianapolis IN USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Mucositis Incidence
Time Frame: 28 days
Presence of Oral Mucositis
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Mucositis Severity
Time Frame: 28 Days
Severity of Oral Mucositis measured using WHO criteria
28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riyadh Colleges of Dentistry and Pharmacy

Collaborators

King Faisal Specialist Hospital & Research Center

Investigators

  • Study Director: abdullah R alshammery, PhD, RiyadhCPD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

January 21, 2016

First Posted (Estimate)

January 25, 2016

Study Record Updates

Last Update Posted (Estimate)

January 25, 2016

Last Update Submitted That Met QC Criteria

January 21, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RiyadhCDP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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