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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low level laser therapy group | Experimental | patients received low level laser therapy using diode laser 980 nm |
|
| Lidocaine gel group | Experimental | patients were instructed to use Lidocaine gel (Oracure gel) 4 times daily. |
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| Chlorhexidine mouthwash group (positive control group). | Experimental | patients were instructed to use Chlorhexidine mouthwash (Orovex) 4 times daily (control group). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low level laser therapy group | Radiation | patients received low level laser therapy using diode laser 980 nm with a low power |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks |
| Parental satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maryam m El Mansy, researcher | The National Research Centre, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the National research Centre | Dokki | Giza Governorate | 12622 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41593123 | Derived | 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. |
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the study design was a single blinded randomized clinical study
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the outcomes assessor was un aware of the type of treatment given to the patient
| Lidocaine gel group | Drug | patients was instructed to use Lidocaine gel (Oracure gel) 4 times daily. |
|
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| Chlorhexidine mouthwash group (positive control group). | Drug | patients was instructed to use Chlorhexidine mouthwash (Orovex) 4 times daily (control group). |
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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 |
| 2 weeks |