Traumatic Ulcer of Oral MucosaNCT07138586

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

A study testing low level laser therapy group and Lidocaine gel group in people with Traumatic Ulcer of Oral Mucosa, run by National Research Centre, Egypt at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 4 to 12 years
Conditions the study is for: Traumatic Ulcer of Oral Mucosa
What is being tested?: low level laser therapy group and Lidocaine gel group
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteEgypt
Study dates: 24 Jan 2025to 1 Jun 2025
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

the National research Centre
Dokki, Giza Governorate, 12622

Other trials in Egypt

About this study

Official title: Evaluation of Low Level Laser Therapy and Lidocaine Versus Chlorhexidine for the Management of Traumatic Oral Ulcers in Children: A Protocol for a Randomized Controlled Study

Read the detailed description

thirty children were randomly allocated to three groups of ten individuals each: Group one: therapy, Group two: using Lidocaine gel 4 times daily and Group three using chlorhexidine mouthwash 4 times daily .

Assessment was done by evaluating pain by Visual Analogue scale; VAS (primary outcome) and assessment of ulcer size by periodontal probe (Secondary outcome) and Parental acceptance of the therapy (tertiary outcome) immediately after treatment, at day two, five, seven, then at two weeks

Conditions: Traumatic Ulcer of Oral Mucosa
Being tested: low level laser therapy group, Lidocaine gel group, Chlorhexidine mouthwash group (positive control group).
Keywords: traumatic oral ulcer- low level laser therapy- chlorohexidine- lidocaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

low level laser therapy groupRadiation
Also called low level laser therapy- biostimulation
patients received low level laser therapy using diode laser 980 nm with a low power
Lidocaine gel groupDrug
Also called Oracure gel
patients was instructed to use Lidocaine gel (Oracure gel) 4 times daily.
Chlorhexidine mouthwash group (positive control group).Drug
Also called Orovex mouthwash
patients was instructed to use Chlorhexidine mouthwash (Orovex) 4 times daily (control group).

Study groups in NCT07138586
Study group	Role	What they receive
low level laser therapy group	Experimental	patients received low level laser therapy using diode laser 980 nm Receives: Radiation: low level laser therapy group
Lidocaine gel group	Experimental	patients were instructed to use Lidocaine gel (Oracure gel) 4 times daily. Receives: Drug: Lidocaine gel group
Chlorhexidine mouthwash group (positive control group).	Experimental	patients were instructed to use Chlorhexidine mouthwash (Orovex) 4 times daily (control group). Receives: Drug: Chlorhexidine mouthwash group (positive control group).

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 2 weeks

Secondary outcomes (2)

Objective assessment of the ulcer size
evaluation of the ulcer size will be done using a graded periodontal probe before the onset of treatment then follow up of the degree of decrease in ulcer size (indicating healing) associated with treatment
Measured: 2 weeks
Parental satisfaction
Parental satisfaction towards treatment procedures, related to duration and frequency of treatment visits will be evaluated using a questionnaire that will be received and answered by the parents at the end of treatment
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 20251 Jun 2025

First posted24 Aug 2025
Study start24 Jan 2025
Primary completion20 Apr 2025
Study completion1 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Traumatic Ulcer of Oral MucosaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: the study design was a single blinded randomized clinical study
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07138586
Sponsor's protocol ID: 0342
Status last verified: Jun 2025
First submitted: 16 Aug 2025
Last updated: 8 Sep 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 41593123

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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