Caries Removal in Primary Teeth Using Er:YAG Laser

NCT05913258 | Completed Phase 3

• 1 other identifier: KAUFD Er:YAG 20230525
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (5)

• Venham's Behavior Rating Scale (VBRS).

  Venham's Behavior Rating Scale is an interval rating scale in which the rating procedure is reliable, valid, and can be easily integrated into clinical or research activities. It is a six-point scale, ranging from 0 to 5 with scale points anchored in objective, specific, and readily observable behavior. Higher scores indicate higher anxiety.

  The treatment procedure (which lasted about 30-45 minutes) was video recorded from start to end. Later, two observers watched the videos to assign each subject a score reflecting his/her behavior throughout the whole procedure time from start to end.

• Baseline Heart rate.

  Heart rate measurement is a direct measure of physiological arousal since its increase is attributed to stress during dental procedures. A pulse oximeter was used to measure the heart rate. The pulse oximeter was placed on the subject finger at the beginning of the dental visit immediately after he/she sat on the dental chair and remained in place until the treatment was completed.

  The baseline heart rate reading was recorded at the beginning of the dental visit immediately after the subject sat on the dental chair.

• Mean Heart rate.

  Heart rate measurement is a direct measure of physiological arousal since its increase is attributed to stress during dental procedures. A pulse oximeter was used to measure the heart rate. The pulse oximeter was placed on the subject finger at the beginning of the dental visit immediately after he/she sat on the dental chair and remained in place until the treatment was completed. Heart rate readings were recorded every 5 minutes until the treatment procedure was finished which lasted about 30-45 minutes.

  The mean heart rate was calculated by averaging the heart readings recorded every 5 minutes from the start until the end of the dental procedure.

• Wong-Baker Pain Scale

  The Wong-Baker scale is a pictorial scale appropriate for children three years and older, that uses pictures of different facial expressions representing different levels of pain from 0-10, face 0 doesn't hurt at all, face 2 hurts just a little bit, face 4 hurts little bit more, face hurts even more, face 8 hurt a whole lot, face 10 hurts as much as you can imagine.

  Immediately after the caries excavation procedure was done, subjects were asked to choose the face on the Wong-Baker Faces Pain Rating Scale that best depicts the pain they were experiencing during treatment.

• Local Anesthesia Administration

  During the dental procedure, if the child experienced pain and requested local anesthesia, the procedure was stopped, local anesthesia was injected, and then the procedure resumed. The number of children who requested local anesthesia during any of the interventions, conventional or laser, was documented.

  The injection of local anesthesia anytime during the 30 to 45 minute dental visit.

Secondary Outcomes (1)

• Restorations' Integrity Evaluation

  follow-up visit one year after the restorations were placed.

Study Arms (2)

Er:YAG Laser Caries Removal group

EXPERIMENTAL

Complete isolation was performed using a rubber dam and saliva ejector. Patients received topical anesthesia before the clamp was placed. Dental caries was excavated using the Er:YAG laser with a wavelength of 2940nm according to the manufacturer's instructions until visual inspection showed that the carious lesions have been thoroughly removed. If the patient experienced pain and requested local anaesthesia, the procedure was stopped, local anaesthesia has been applied, and then the procedure has resumed. Cavities were restored using the Clearfil Universal Bond Quick system in total each mode; 37% phosphoric acid was used, then the Clearfil Universal Bond system was applied, light cured for 90 seconds, after which composite resin was applied (3M Filtek TM Z350 XT Universal Restorative Composite (3M ESPE) according to the manufacturer's instructions.

Device: Er:YAG laser system (Doctor smile, Pluser, Italy)

Conventional Caries Removal Group

ACTIVE COMPARATOR

Complete isolation was performed using a rubber dam and saliva ejector. Patients received topical anesthesia before the clamp was placed. Dental caries was excavated using the Mastertorque high/low-speed air rotor handpiece until visual inspection showed that the carious lesions have been thoroughly removed. If the patient experienced pain and requested LA, the procedure was stopped, LA was applied, and then the procedure resumed. According to the manufacturer's instructions, cavities were restored using the Clearfil Universal Bond Quick system and composite resin (3M Filtek TM Z350 XT Universal Restorative Composite (3M ESPE).

Device: Master Torque high/low-speed air rotor handpiece (KaVo Dental, Charlotte, North Carolina, USA)

Interventions

Er:YAG laser system (Doctor smile, Pluser, Italy) DEVICE

The Er:YAG laser offers a virtually painless alternative to conventional methods of caries removal, and its adoption in clinical practice could greatly reduce children's fear of going to the dentist. Caries removal is one of the leading reasons for dentist visits among children, and many children become fearful at the mere thought of a drill touching their teeth, before they even hear the sound. Laser caries removal could go a long way toward eliminating children's fear of going to the dentist; it is virtually painless, and most children are able to get through the entire procedure without needing local anesthesia.

Er:YAG Laser Caries Removal group

Master Torque high/low-speed air rotor handpiece (KaVo Dental, Charlotte, North Carolina, USA) DEVICE

Mechanical removal of carious lesions with a rotating handpiece and bur instruments is the most often used approach for treating dental caries because it is cost-effective, timesaving, and simple. However, these procedures have many drawbacks, including the potential for removing healthy tooth structures, vibration and noise, which can cause the patient anxiety and pain, thus necessitating local anesthesia.

Conventional Caries Removal Group

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy patients between 9 and 12 years of age.
• Simple occlusal caries that is limited to enamel and dentine without proximal caries, or pulp involvement in at least two primary molars (pairs).
• Primary molars with 1/3rd of their root remained.
• Primary teeth have permanent successor teeth with 1/2 of the root formed.

You may not qualify if:

• Caries lesion that had reached or was approaching the pulp.
• Previous fillings.
• Periapical lesions, or dental abscess.
• No permanent successor teeth.
• Behavioral or medical problem.

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University

Jeddah, 21589, Saudi Arabia

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The examiner who clinically evaluated the restorations using Ryge criteria did not know which tooth had received which treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Pediatric Dentistry

Model Details: A randomized, blinded split-mouth study. The children were randomly assigned into one of two groups randomly. The first group included were assigned to receive the conventional treatment at the first visit and the laser treatment at the second visit. The second group was assigned to receive the laser treatment at the first visit and the conventional treatment at the second visit.

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 22, 2023
• Study Start: January 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

SA (1)