Clincosm LogoSign in Get a demo

Oral Hygiene Regimen in Patients on HCT

Sponsor
Riyadh Colleges of Dentistry and Pharmacy (Other)
Overall Status
Unknown status
CT.gov ID
NCT02662374
Collaborator
King Faisal Specialist Hospital & Research Center (Other)
45
Enrollment
3
Arms
8
Duration (Months)

Study Details

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.
Condition or Disease Intervention/Treatment Phase
  • Drug: .02% Chlorohexidine Gluconate
  • Drug: 3% Sodium Bicarbonate
  • Drug: Nystatin 10000U/ml
  • Device: Extra Soft Toothbrush
  • Drug: Supersaturated Calcium Phosphate
 Phase 4

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

  1. 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 Design

Study Type:
Interventional
Anticipated 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 :
Sep 1, 2015
Anticipated Primary Completion Date :
Apr 1, 2016
Anticipated Study Completion Date :
May 1, 2016

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Oral Mucositis Incidence [28 days]

      Presence of Oral Mucositis

    Secondary Outcome Measures

    1. Oral Mucositis Severity [28 Days]

      Severity of Oral Mucositis measured using WHO criteria

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Riyadh Colleges of Dentistry and Pharmacy
    • King Faisal Specialist Hospital & Research Center

    Investigators

    • Study Director: abdullah R alshammery, PhD, RiyadhCPD

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sarah Ali Mubaraki, Post Graduate in Pediatric Dentistry, Riyadh Colleges of Dentistry and Pharmacy
    ClinicalTrials.gov Identifier:
    NCT02662374
    Other Study ID Numbers:
    • RiyadhCDP
    First Posted:
    Jan 25, 2016
    Last Update Posted:
    Jan 25, 2016
    Last Verified:
    Jan 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Mucositis
    Stomatitis
    Nystatin
    Calcium

    Study Results

    No Results Posted as of Jan 25, 2016