NCT04591418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

September 24, 2020

Last Update Submit

October 19, 2020

Conditions

Dental Caries in Children

Keywords

Er:YAG laserCaries removalDental anxietyAcceptability

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Rotary handpieces

ACTIVE COMPARATOR
Device: Rotary handpieces

Er:YAG laser

EXPERIMENTAL
Device: Er:YAG laser

Interventions

Rotary handpiecesDEVICE

Dental Caries removal

Rotary handpieces
Er:YAG laserDEVICE

Dental Caries removal

Er:YAG laser

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, 01130, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Lasers, Solid-State

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 24, 2020

First Posted

October 19, 2020

Study Start

December 1, 2019

Primary Completion

March 23, 2020

Study Completion

September 15, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Locations

TU(1)