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Completed

NCT Number: NCT07138586

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

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

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the National research Centre

Dokki, Giza Governorate, 12622, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low level laser therapy group

Radiation

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

Other names: low level laser therapy- biostimulation

Lidocaine gel group

Drug

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

Other names: Oracure gel

Chlorhexidine mouthwash group (positive control group).

Drug

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

Other names: Orovex mouthwash

Primary outcomes

  1. 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

Secondary outcomes

  1. Objective assessment of the ulcer size

    Time frame: 2 weeks

    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. Parental satisfaction

    Time frame: 2 weeks

    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

Sponsors and collaborators

Lead sponsor

National Research Centre, Egypt

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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