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.
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
- Are there results?
- None posted in the registry
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.
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
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 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam m El Mansy, researcher, Principal investigator, The National Research Centre, Egypt
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07138586
- Acronym / sponsor ID
- 0342
- Conditions
- Traumatic Ulcer of Oral Mucosa
- Keywords
- traumatic oral ulcer- low level laser therapy- chlorohexidine- lidocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- the study design was a single blinded randomized clinical study
| Arm | Type | Receives |
|---|---|---|
| low level laser therapy group | Experimental | Radiation: low level laser therapy grouppatients received low level laser therapy using diode laser 980 nm |
| Lidocaine gel group | Experimental | Drug: Lidocaine gel grouppatients were instructed to use Lidocaine gel (Oracure gel) 4 times daily. |
| Chlorhexidine mouthwash group (positive control group). | Experimental | Drug: Chlorhexidine mouthwash group (positive control group).patients were instructed to use Chlorhexidine mouthwash (Orovex) 4 times daily (control group). |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low level laser therapy groupAlso: low level laser therapy- biostimulationpatients received low level laser therapy using diode laser 980 nm with a low power | Radiation | low level laser therapy group |
| Lidocaine gel groupAlso: Oracure gelpatients was instructed to use Lidocaine gel (Oracure gel) 4 times daily. | Drug | Lidocaine gel group |
| Chlorhexidine mouthwash group (positive control group).Also: Orovex mouthwashpatients was instructed to use Chlorhexidine mouthwash (Orovex) 4 times daily (control group). | Drug | Chlorhexidine mouthwash group (positive control group). |
Primary outcome
Subjective pain assessment of the ulcer
Time frame: 2 weeks
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 secondary outcomes
Objective assessment of the ulcer size
Time frame: 2 weeks
Parental satisfaction
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Derived from this study: PubMed 41593123Mansy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryam m El Mansy, researcher principal investigator
The National Research Centre, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective pain assessment of the ulcer (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07138586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.