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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Subjective pain assessment of the ulcer
Study Overview
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
Study Design
- Study Type
- Interventional
- 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
Eligibility Criteria
- Ages
- 4 Years to 12 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
low level laser therapy group
patients received low level laser therapy using diode laser 980 nm
Intervention: low level laser therapy group (Radiation)
Lidocaine gel group
patients were instructed to use Lidocaine gel (Oracure gel) 4 times daily.
Intervention: Lidocaine gel group (Drug)
Chlorhexidine mouthwash group (positive control group).
patients were instructed to use Chlorhexidine mouthwash (Orovex) 4 times daily (control group).
Intervention: Chlorhexidine mouthwash group (positive control group). (Drug)
Outcomes
Primary Outcomes
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
- Objective assessment of the ulcer size(2 weeks)
- Parental satisfaction(2 weeks)