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

October 19, 2020 updated by: volkan Ciftci, Cukurova University

Farklı çürük Temizleme yöntemlerinin çocuk Hastalarda Klinik Olarak karşılaştırılması

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey, 01130
        • Cukurova University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Rotary handpieces
Device: Rotary handpieces
Dental Caries removal
EXPERIMENTAL: Er:YAG laser
Device: Er:YAG laser
Dental Caries removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort
Time Frame: through study completion, an average of 6 months
Units on a Scale ( Patient comfort was evaluated with Facial Image Scale after treatment. Patients signed from 1 to 5 score for treatment comfort.The data were collected and statistically analysed using by the numerical data. In this study, "1" and "2" scores are considered as better outcome. Patients who signed these scores described as good comfortable. The worst outcome is considered as the patients signed "4-5". Each scale range for each time interval evaluated as count of patient and presented as percentage.)
through study completion, an average of 6 months
Dental anxiety
Time Frame: through study completion, an average of 6 months
Units on a Scale (Dental anxiety was evaluated with Dental Subscale of the Children's Fear Survey Schedule after treatment. The patients signed from 0 to 38 score for dental anxiety after the treatment.The data were collected and statistically analysed using by the numerical data. In this study, " 0-38" scores are considered as better outcome. Patients who were have these scores described no dental anxiety for treatment. The worst outcome is considered as the patients have ">38". Each scale range for each time interval evaluated as count of patient and presented as percentage.)
through study completion, an average of 6 months
Changes in pain
Time Frame: through study completion, an average of 6 months
Units on a Scale (Changes in pain was evaluated with Legs, Activity, Cry, Consolability scale after treatment. Observer signed from 0 to 3 score for treatment pain during the treatment.The data were collected and statistically analysed using by the numerical data. In this study, "0" and "1" scores are considered as better outcome. Patients who were signed these scores described as no pain for treatment. The worst outcome is considered as the patients signed "2-3". Each scale range for each time interval evaluated as count of patient and presented as percentage.)
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2019

Primary Completion (ACTUAL)

March 23, 2020

Study Completion (ACTUAL)

September 15, 2020

Study Registration Dates

First Submitted

September 24, 2020

First Submitted That Met QC Criteria

October 12, 2020

First Posted (ACTUAL)

October 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 94/57

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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