A Comparative Clinical Study of Different Caries Removal Techniques in Pediatric Patients

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-09-15

Brief Summary

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The aim of this study is to evaluate the acceptance of pediatric patiens using Er: YAG laser in comparison with the conventional techniques for caries removal.

The study was carried out on 100 children between the ages of 9-12, who had class 1 occlusal caries in one of their permanent first molars. The patients were divided into two groups; conventional technical group and laser group. Rotary handpieces was used in conventional technique group, Er:YAG laser was used in the laser group for caries removal. The heart rate of each patient was measured during the caries removal procedure at 30 seconds intervals. The pain during the procedure was determined by VAS. CFSS-DS scale was used to determine the anxiety level of the patients before and after the procedure. FIS was used to determine how patients are disturbed from the smell, taste, sound, vibration and sight of the devices after the procedure. The video segments were collected from the patients during the caries removal and the procedural pain were evaluated by the FLACC scale.

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Detailed Description

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Based our results, ın the laser group, the patients were found to experience less pain and discomfort compared to conventional technique according to the VAS and FLACC scores. The rate of patients with dental anxiety decreased significantly in the laser group compared with the conventional group according to CFSS-DS performed after the procedure. According to the sensory survey, the laser group had good acceptability compared to the conventional technique group in terms of vibration and sight. The laser group showed a lower percentage increase in heart rate comparsion between beginning and end of procedure. It was observed that the cavity preparation time was longer in the laser group.

Conditions

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Dental Caries in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Rotary handpieces

Group Type ACTIVE_COMPARATOR

Rotary handpieces

Intervention Type DEVICE

Dental Caries removal

Er:YAG laser

Group Type EXPERIMENTAL

Er:YAG laser

Intervention Type DEVICE

Dental Caries removal

Interventions

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Rotary handpieces

Dental Caries removal

Intervention Type DEVICE

Er:YAG laser

Dental Caries removal

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients age between 9-12 years old
* Having no systemic condition and ASA 1 healty status
* Having lower permanent first molar teeth with occlusal caries (class 1)
* having no laser treatment before

Exclusion Criteria

* having spontaneous tooth pain
* having high dental anxiety
* having no restorative treatment before
* teeth with periapical pathology, a root filling or non-vital teeth.

Minimum Eligible Age

9 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes