NCT05913258

Caries Removal in Primary Teeth Using Er:YAG Laser

Completed Phase 3 Last updated 22 June 2023

What this trial tests

Phase 3 trial testing Er:YAG laser system (Doctor smile, Pluser, Italy) in Dental Caries in 40 participants. Completed in 1 March 2022.

Timeline

1 January 2020

Primary endpoint
1 March 2022

1 March 2022

Quick facts

Lead sponsor	King Abdulaziz University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	1 January 2020
Primary completion	1 March 2022
Estimated completion	1 March 2022
Sites	1 location across Saudi Arabia

Drugs / interventions tested

• Er:YAG laser system (Doctor smile, Pluser, Italy)
• Master Torque high/low-speed air rotor handpiece (KaVo Dental, Charlotte, North Carolina, USA)

Conditions studied

• Dental Caries — all drugs for Dental Caries →

Sponsor

King Abdulaziz University

Who can join

Adults 9 to 12, any sex, with Dental Caries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Restoration Integrity in Primary Teeth Prepared Using Erbium/Yttrium-Aluminum-Garnet Laser: A Randomized Split-Mouth Clinical Study.
   Abdrabuh R, El Meligy O, Farsi N, Bakry AS, et al · · 2023 · cited 2× · PMID 37508712 · DOI 10.3390/children10071215
2. Micro-Morphological Features of the Er:YAG-Lased Interface in Primary Teeth: 12 Months Randomized Split-Mouth Trial.
   Felemban O, Abdrabuh R, El Meligy O, Farsi N, et al · · 2024 · cited 1× · PMID 38248684 · DOI 10.3390/jfb15010017