NCT07138586

Brief Summary

the goal of the study was to evaluate the pain reduction and healing efficiency of traumatic oral ulcers in children using low-level laser therapy with diode laser 980 nm, lidocaine oral gel and chlorhexidine mouthwash

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 24, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
Last Updated

September 8, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

August 16, 2025

Last Update Submit

September 1, 2025

Conditions

Traumatic Ulcer of Oral Mucosa

Keywords

traumatic oral ulcer- low level laser therapy- chlorohexidine- lidocaine

Outcome Measures

Primary Outcomes (1)

  • Subjective pain assessment of the ulcer

    evaluation of pain associated with the ulcer will be evaluated using visual analoque scale (VAS) before the onset of treatment then follow up of the degree of pain relief associated with treatment

    2 weeks

Secondary Outcomes (2)

  • Objective assessment of the ulcer size

    2 weeks

  • Parental satisfaction

    2 weeks

Study Arms (3)

low level laser therapy group

EXPERIMENTAL

patients received low level laser therapy using diode laser 980 nm

Radiation: low level laser therapy group

Lidocaine gel group

EXPERIMENTAL

patients were instructed to use Lidocaine gel (Oracure gel) 4 times daily.

Drug: Lidocaine gel group

Chlorhexidine mouthwash group (positive control group).

EXPERIMENTAL

patients were instructed to use Chlorhexidine mouthwash (Orovex) 4 times daily (control group).

Drug: Chlorhexidine mouthwash group (positive control group).

Interventions

low level laser therapy groupRADIATION

patients received low level laser therapy using diode laser 980 nm with a low power

Also known as: low level laser therapy- biostimulation
low level laser therapy group
Lidocaine gel groupDRUG

patients was instructed to use Lidocaine gel (Oracure gel) 4 times daily.

Also known as: Oracure gel
Lidocaine gel group
Chlorhexidine mouthwash group (positive control group).DRUG

patients was instructed to use Chlorhexidine mouthwash (Orovex) 4 times daily (control group).

Also known as: Orovex mouthwash
Chlorhexidine mouthwash group (positive control group).

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children from 4-12 years without any apparent medical problem
  • Children with history of receiving a dental procedure in the same or the previous day of the onset of ulcer.
  • Children having restorations or teeth with sharp edges.
  • Children with orthodontic or any other oral appliance.
  • No previous treatment with any modality for the ulcer.
  • Willingness to participate in the proposed clinical study.

You may not qualify if:

  • Patients who had psychological or mental diseases.
  • Patient under anticoagulants, anti-inflammatory or immunosuppressant medications.
  • Children with systemic (endocrine-metabolic) disease; rheumatologic disease; hormone disorder; immunodeficiency; use of corticoid-based therapy.
  • Uncooperative children or parents.
  • Patients who did not participate twice weekly in the evaluations were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the National research Centre

Dokki, Giza Governorate, 12622, Egypt

Location

Related Publications (1)

  • Mansy ME, Rashed MF. Evaluation of low level laser therapy and lidocaine versus chlorohexidine for the management of traumatic oral ulcers in children: a randomized controlled study. Sci Rep. 2026 Jan 27;16(1):3738. doi: 10.1038/s41598-025-34529-8.

    PMID: 41593123DERIVED

Study Officials

  • Maryam m El Mansy, researcher

    The National Research Centre, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
the outcomes assessor was un aware of the type of treatment given to the patient
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: the study design was a single blinded randomized clinical study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2025

First Posted

August 24, 2025

Study Start

January 24, 2025

Primary Completion

April 20, 2025

Study Completion

June 1, 2025

Last Updated

September 8, 2025

Record last verified: 2025-06

Locations

EG(1)