Caries Removal in Primary Teeth Using Er:YAG Laser - Trial NCT05913258
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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Study Focus
Sponsor & Location
King Abdulaziz University
Timeline & Enrollment
Phase 3
Jan 01, 2020
Mar 01, 2022
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
Data Source
ClinicalTrials.gov
NCT05913258
Device Trial