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

Dental Caries in Children Clinical Trial

Official title:

Farklı çürük Temizleme yöntemlerinin çocuk Hastalarda Klinik Olarak karşılaştırılması

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04591418
• Other study ID #: 94/57
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: September 15, 2020

Study information

• Verified date: October 2020
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 15, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Device:
• Rotary handpieces
Dental Caries removal
• Er:YAG laser
Dental Caries removal

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort	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
Primary	Dental anxiety	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
Primary	Changes in pain	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