Comparative Study Between Smart Bur II and Traditional Carbide Bur in Selective Removal of Caries in Permanent Molars

NCT06187259 | Completed DMC

• 1 other identifier: Caries removal by polymer burs
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A more biological and conservative technique of caries removal has emerged with minimally invasive restorative dentistry's advent. As a result, Smart Burs II has become a self-limiting, sensitive tool for removing caries. The current study aimed to validate and contrast the polymer burs' efficacy (Smart Burs II) versus conventional burs (Carbide burs) for infected carious dentin's selective removal in permanent first molars. Thirty permanent first molars fulfilling the inclusion criteria were chosen in 8-11 years old children with class I occlusal carious lesions. Group 1 (n=15) and Group 2 (n=15) were randomly assigned to have carious dentin removed utilizing standard carbide bur and a smart Bur II, consecutively. By employing caries detector dye, the effectiveness of caries removal was quantified as 0, 1, 2, 3, 4, or 5. The volume of removed carious tissue was recorded using impression material which was inserted into a calibrated insulin syringe. A statistically significant difference was discovered in the volume of removed carious tissue between both groups, while the efficiency of caries removal using either bur has no significant difference. Smart Bur II was more conservative in the carious dentin's removal than carbide bur. Smart Bur II was as efficient as carbide bur in caries removal.

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (4)

• Assessment of caries removal efficiency by visual examination

  Visual examination to assess the color of dentin and evidence of the presence or absence of soft caries.

  baseline (immediately after caries removal procedures) Up to 3 minutes, no follow up is required.

• Assessment of caries removal efficiency by tactile examination

  Tactile sensation to assess the texture, hardness, and consistency of dentin, i.e. the explorer should not stick to the dentin when moved along the surface without a catch or a tug-back sensation.

  baseline (immediately after caries removal procedures) Up to 5 minutes, no follow up is required

• Assessment of caries removal efficacy by using caries detector dye

  Caries removal efficacy was assessed using the Ericson rating scale "The Ericson rating scale was used to assess the residual caries. Caries removal status scores are defined as 0, 1,2,3,4, or 5, with 5 indicating the highest residual caries.

  baseline (immediately after caries removal procedures) Up to 10 minutes, no follow up is required.

• Assessment of the volume of the removed carious tissue in cubic millimeters (mm3)

  Using impression material and a calibrated insulin syringe for both groups, the amount of removed carious tissue was measured by computing the difference between the cavity's initial volume before caries removal and the final volume of the cavity after caries removal

  baseline (immediately after caries removal procedures) Up to 15 minutes, no follow up is required.

Study Arms (2)

carbide bur group

ACTIVE COMPARATOR

carbide burs are extremely hard and can withstand high temperatures. Because of their hardness, carbide burs can maintain a sharp cutting edge and can be used many times without becoming dull. They are best operated at high speeds with light pressure. Carbide dental bur was designed to, efficiently, remove non-decalcified enamel and dentin, yet, it does not facilitate the differentiation between carious and normal dentin, during cavity preparation.

Device: caries removal by carbide bur

polymer bur II group

EXPERIMENTAL

Polymer bur tools resemble conventional burs in appearance, but they are made of unique polymer material rather than metal. The cutting edges are not spiral, like those of a shovel. The polymer material was designed to be softer than healthy dentin (Knoop hardness 70-90) but harder than carious, softening dentin (Knoop hardness 50-70) (Knoop hardness 0-30). Therefore, it has a knoop hardness of 50 kg/mm2, and its cutting elements effectively remove soft dentin but cannot remove healthy dentin.

Device: caries removal by polymer bur II

Interventions

caries removal by carbide bur DEVICE

caries was removed using a slow-speed handpiece and round carbide burs in sizes #12, #14, and #16, based on the lesion's size. When hard dentin was found using a dental probe, carious dentin removal was stopped.

carbide bur group

caries removal by polymer bur II DEVICE

carious tissue was removed utilizing smart polymer burs of sizes #4, #6, and #8, depending on the cavity's size, running at a slow speed without water coolant, in circular motions from the center of the lesion outward. Carious dentin removal ceased when the instrument became macroscopically abraded and sharpened and could no longer remove tooth tissues.

polymer bur II group

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children of both genders in the age group of 8-11 years and rated as definitely positive or positive using Frankl Behaviour Rating Scale
• permanent first molars with class I (occlusal) active carious lesion classified as code 5 , according to the international caries detection and assessment system, involving dentin with a cavity opening diameter of 2mm.
• Permanent molars with absence of peri-apical or inter-radicular radiolucency.

You may not qualify if:

• Molars with developmental anomalies.
• Decayed molars that show clinical or radiographic evidence of pulpal involvement.
• Parental refusal to sign the informed consent.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of Medicine, Suez canal university

Ismailia, Egypt

Location

Study Officials

• Ghada AH El baz, professor

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: January 2, 2024
• Study Start: April 18, 2019
• Primary Completion: May 25, 2021
• Study Completion: June 22, 2021
• Last Updated: February 13, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)