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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07138586
Enrollment
30
Registered
2025-08-24
Start date
2025-01-24
Completion date
2025-06-01
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Ulcer of Oral Mucosa

Keywords

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

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

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

Interventions

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

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

DRUGChlorhexidine mouthwash group (positive control group).

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

Sponsors

National Research Centre, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

the outcomes assessor was un aware of the type of treatment given to the patient

Intervention model description

the study design was a single blinded randomized clinical study

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Subjective pain assessment of the ulcer2 weeksevaluation 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

Secondary

MeasureTime frameDescription
Objective assessment of the ulcer size2 weeksevaluation 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
Parental satisfaction2 weeksParental 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026