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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-24

Study Completion Date

2025-06-01

Brief Summary

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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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Detailed Description

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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

Conditions

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Traumatic Ulcer of Oral Mucosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

the study design was a single blinded randomized clinical study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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low level laser therapy group

patients received low level laser therapy using diode laser 980 nm

Group Type EXPERIMENTAL

low level laser therapy group

Intervention Type RADIATION

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

Lidocaine gel group

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

Group Type EXPERIMENTAL

Lidocaine gel group

Intervention Type DRUG

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

Chlorhexidine mouthwash group (positive control group).

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

Group Type EXPERIMENTAL

Chlorhexidine mouthwash group (positive control group).

Intervention Type DRUG

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

Interventions

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low level laser therapy group

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

Intervention Type RADIATION

Lidocaine gel group

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

Intervention Type DRUG

Chlorhexidine mouthwash group (positive control group).

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

Intervention Type DRUG

Other Intervention Names

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low level laser therapy- biostimulation Oracure gel Orovex mouthwash

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No