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

National Research Centre, Egypt

Status: Completed

Conditions: Traumatic Ulcer of Oral Mucosa

Treatments: Radiation: low level laser therapy group; Drug: Chlorhexidine mouthwash group (positive control group).; Drug: Lidocaine gel group

Study type: Interventional

Funder types: Other

Identifiers

NCT07138586

0342

Details and patient eligibility

About

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

Full 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

Enrollment: 30 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

low level laser therapy group

Experimental group

Description:

patients received low level laser therapy using diode laser 980 nm

Treatment:

Radiation: low level laser therapy group

Lidocaine gel group

Experimental group

Description:

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

Treatment:

Drug: Lidocaine gel group

Chlorhexidine mouthwash group (positive control group).

Experimental group

Description:

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

Treatment:

Drug: Chlorhexidine mouthwash group (positive control group).