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

National Research Centre, Egypt30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Traumatic Ulcer of Oral Mucosa

Interventions

low level laser therapy groupRADIATION

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

Lidocaine gel groupDRUG

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

Chlorhexidine mouthwash group (positive control group).DRUG

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

Eligibility

Sex: ALLMin age: 4 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

the National research Centre

Dokki, Giza Governorate, Egypt

Outcomes

Primary Outcomes

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

Time frame: 2 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 2 weeks

Data from ClinicalTrials.gov

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