Clinical trial NCT04591418: A Comparative Clinical Study of Different Caries Removal Techniques in Pediatric Patients
Official title: Farklı çürük Temizleme yöntemlerinin çocuk Hastalarda Klinik Olarak karşılaştırılması
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Keywords: Er:YAG laser
Caries removal
Dental anxiety
Acceptability
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comfort
timeFrame: through study completion, an average of 6 months
measure: Dental anxiety
timeFrame: through study completion, an average of 6 months
measure: Changes in pain
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
References: