Trials Sponsors Conditions Drugs Pricing

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).

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:

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.

Sponsors & Collaborators

National Research Centre, Egypt
Otherlead

Study Sites (1)

the National research Centre

Dokki, Giza Governorate, 12622, Egypt

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

Enrollment

30 participants (actual enrollment reported by the registry).

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
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 16, 2025

First Posted

August 24, 2025

Study Start

January 24, 2025

Evaluation of Low Level Laser Therapy and Lidocaine Versus Chlorhexidine for the Management of Traumatic Oral Ulcers in Children

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (3)

low level laser therapy group

Lidocaine gel group

Chlorhexidine mouthwash group (positive control group).

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (3)

low level laser therapy group

Lidocaine gel group

Chlorhexidine mouthwash group (positive control group).

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations