NCT05913258

Caries Removal in Primary Teeth Using Er:YAG Laser

Evaluation of Caries Removal in Primary Teeth Using an Er:YAG Laser: A Randomized Split-Mouth Clinical Trial
King Abdulaziz University·Phase 3·ClinicalTrials.gov·device·Device trialCompleted
View on ClinicalTrials.gov
Study focus
Disease/Condition
Dental Caries
Drug/Device/Intervention
Er:YAG laser system (Doctor smile, Pluser, Italy)
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
King Abdulaziz University
Location
Jeddah, Saudi Arabia
Timeline & enrollment
Phase
Phase 3
Start date
Jan 01, 2020
End date
Mar 01, 2022
Enrollment
40 participants
Primary outcome

Venham's Behavior Rating Scale (VBRS).,Baseline Heart rate.,Mean Heart rate.,Wong-Baker Pain Scale,Local Anesthesia Administration

Summary

Objective: To assess and compare the 2940 nm erbium:yttrium-aluminum-garnet (Er:YAG) laser
 versus a conventional rotary treatment during cavity preparation in children with regard to
 anxiety level, pain perception, restoration integrity, and bond interface quality.
 
 Materials and Methods: In a randomized, blinded trial using a split-mouth design, forty
 (9-12-year-old) children with 80 carious deciduous molars were included. The cavity in one
 quadrant was treated conventionally using a bur, while the cavity in the other quadrant was
 prepared using an Er:YAG laser. Venham's dental anxiety scale and pulse rate measurement
 using a fingertip pulse oximeter were used to evaluate dental anxiety levels. The Wong-Baker
 facial pain rating scale and the number of local anesthesia required during both
 interventions were further applied to investigate pain perception. At the 1-year follow-up,
 clinical examinations was conducted and the integrity of the restorations was clinically
 assessed according to the Ryge criteria. Lastly, the restored teeth were extracted and
 histologically evaluated for bond interface quality using scanning electronic microscopy.

ICD-10 classifications
Dental cariesOther dental cariesDental caries, unspecifiedCaries of dentineCaries limited to enamel
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05913258
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT05913258 through Pure Global AI's free database. This Phase 3 trial is sponsored by King Abdulaziz University and is currently Completed. The study focuses on Dental Caries. Target enrollment is 40 participants.

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