NCT05181943

Brief Summary

The aim of the current study was to study the effect of diode laser in the treatment of chemotherapy induced mucositis in young patients suffering from leukemia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
Last Updated

January 10, 2022

Status Verified

December 1, 2021

Enrollment Period

1.1 years

First QC Date

December 20, 2021

Last Update Submit

December 20, 2021

Conditions

Mucositis

Keywords

mucositis - leukemia - chemotherapy

Outcome Measures

Primary Outcomes (2)

  • Self-reported pain level

    Participants were asked to report the degree of pain. This was assessed using the visual analogue scale (VAS) which ranges from zero (lowest score) to 10 (highest score). Higher scores indicate higher pain level.

    up to 2 weeks

  • Oral mucositis lesion size

    This was assessed using the World Health Organization oral mucositis lesion score Grade 0: no oral mucositis. Grade1: Presence of soreness and erythema. Grade 2: Presence of painful erythema and ulcerations that do not affect the patient solid food intake. Grade3: Confluent ulceration that affect the solid food intake and require liquid diet. Grade 4: The patient requires parenteral nutrition.

    up to 2 weeks

Study Arms (2)

Laser irradiation (Test group)

EXPERIMENTAL

laser irradiation over lesion

Device: Simpler diode laser

Conventional treatment (Control group

ACTIVE COMPARATOR
Drug: Conventional symptomatic treatment

Interventions

Simpler diode laserDEVICE

Non-contacting irradiation for 30 seconds on three intraoral sites repeated four times

Laser irradiation (Test group)
Conventional symptomatic treatmentDRUG

Conventional treatment using oracure, BBC spray, miconaz three times daily

Conventional treatment (Control group

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children diagnosed with mucositis and receiving chemotherapy

You may not qualify if:

  • diabetes
  • trismus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

Location

MeSH Terms

Conditions

Mucositis

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor of Oral Medicine

Study Record Dates

First Submitted

December 20, 2021

First Posted

January 10, 2022

Study Start

October 1, 2020

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

January 10, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)