NCT02662374

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

January 19, 2016

Last Update Submit

January 21, 2016

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (1)

  • Oral Mucositis Incidence

    Presence of Oral Mucositis

    28 days

Secondary Outcomes (1)

  • Oral Mucositis Severity

    28 Days

Study Arms (3)

Control

ACTIVE COMPARATOR

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 GluconateDrug: 3% Sodium BicarbonateDrug: Nystatin 10000U/ml

Group 1

EXPERIMENTAL

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 GluconateDrug: 3% Sodium BicarbonateDrug: Nystatin 10000U/mlDevice: Extra Soft Toothbrush

Group 2

EXPERIMENTAL

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 GluconateDrug: 3% Sodium BicarbonateDrug: Nystatin 10000U/mlDrug: Supersaturated Calcium Phosphate

Interventions

.02% Chlorohexidine GluconateDRUG

5ml of the drug in mouthwash form to be swished four times a day

Also known as: Clorasept (ArRiyadh Pharmaceuticals, Riyadh, Saudi Arabia)
ControlGroup 1Group 2
3% Sodium BicarbonateDRUG

5ml of the drug in the form of a prepared solution to be swished four times a day

Also known as: 3% Na2CO3
ControlGroup 1Group 2
Nystatin 10000U/mlDRUG

5ml of the drug in mouthwash form to be swished and swallowed four times a day

Also known as: Mycostatin (Amman Pharmacuetical Corp. Amman, Jordan
ControlGroup 1Group 2
Extra Soft ToothbrushDEVICE

To be moistened with 0.9% normal Saline and used twice daily to remove dental plaque

Group 1
Supersaturated Calcium PhosphateDRUG

5ml of the solution to be swished four times a day

Also known as: Moistir (Kingswood laboratories Inc., Indianapolis IN USA)
Group 2

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Patient age greater than 16 years and less than 3 years.
  • Previous radiotherapy
  • Had more than one graft.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomatitis

Interventions

Sodium BicarbonateNystatin

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsMacrolidesLactonesOrganic Chemicals

Study Officials

  • abdullah R alshammery, PhD

    RiyadhCPD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Graduate in Pediatric Dentistry

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 25, 2016

Study Start

September 1, 2015

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

January 25, 2016

Record last verified: 2016-01