Comparison of Intraoperative Pain Perception During Caries Excavation Using Smart Burs and Carisolv to Conventional Diamond Burs

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorRehman Medical Institute - RMI

About this trial

The goal of this randomized controlled trial is to compare the amount of pain experienced during removal of dental caries using Smart burs, Carisolv, and conventional diamond burs in adults aged 18-45 years with active caries in asymptomatic mandibular molars.

The main questions it aims to answer are:

Does the method used for caries removal affect the amount of pain experienced?

Is there a difference in pain perception between Smart burs, Carisolv, and conventional diamond burs?

Researchers will compare the three treatment groups to see whether pain perception during caries excavation differs between the methods.

Participants will:

Be randomly assigned to one of three groups: Smart burs, Carisolv, or conventional diamond burs.

Undergo caries removal using the assigned method.

Rate their pain during the procedure using a 0-10 Visual Analogue Scale (VAS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be male or female.

Be 18-45 years of age.

Have at least one active carious lesion with exposed dentin in an asymptomatic mandibular molar.

Have an ICDAS II Code 5 lesion: a dentinal cavity clearly visible clinically, with the cavity surface feeling soft or leathery on gentle probing.

Disqualifiers

Symptoms/signs of pulpitis.

Pulp exposure.

Abscess formation, including swelling, redness, or a fistula adjacent to the affected tooth.

Necrotic pulp, indicated by lack of response to cold testing.

Trial design

Design model

Parallel

Treatments tested in this trial

  • polymer burs

    Device

    Carious dentin will be selectively excavated using Smart polymer burs operated at low speed (500-800 rpm), aiming to preserve sound dentin.

  • Carisolv

    Device

    Carious dentin will be chemically softened using Carisolv gel and subsequently removed with hand instruments.

  • Conventional Diamond Burs

    Device

    Carious dentin will be removed using conventional rotary diamond burs under standard clinical operative dentistry procedures.

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: Smart/Polymer BursExperimental treatment 1 intervention
Group B: CarisolvExperimental treatment 1 intervention
Group C: Conventional Diamond BursActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intraoperative Pain Perception During Caries Excavation assessed using Visual Analogue Scale (VAS)

Intraoperative pain perception will be determined on visual analogue scale (VAS) to measure the pain intensity experienced by the patients during caries excavation. VAS involves scores from 0 to 10 where 0 indicates no pain and 10 represents worst pain possible. The VAS score will be recorded immediately after completion of caries excavation.

Time frame
immediately after completion of caries excavation

Secondary outcomes

Other outcomes

Sponsors and contacts

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