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Pain During Caries ExcavationNCT07869407

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

A study testing polymer burs, Carisolv and Conventional Diamond Burs in people with Pain During Caries Excavation, run by Rehman Medical Institute - RMI at 1 site in Pakistan.

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Sites and contacts
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Pain During Caries Excavation
What is being tested?
polymer burs, Carisolv and Conventional Diamond Burs
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 sitePakistan
Study dates
1 Jul 2026to 30 Jan 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
  • Have a radiograph showing a clear band of dentin between the carious lesion and the pulp.
  • Provide written informed consent to participate.

Who cannot join

  • 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.
  • Cardiovascular disease.
  • Diabetes mellitus.
Show all 10Show fewer
  • Hypertension.
  • Severe periodontal disease.
  • Pregnancy.
  • Unwillingness or inability to provide informed consent/participate.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tehreema Naureen, Bachelor of Dental Surgery contact

+923325566872

tnaureen41@gmail.com

Pakistan1 site, 1 recruiting
  • Rehman College of Dentistry

    Peshawar, Khyber Pakhtunkhwa, 25000

    Meera Tanveer, Public Health, +923349534604, meera.tanveer@rmi.edu.pk

    Tehreema Naureen, Bachelor of Dental Surgery

    Recruiting

Other trials in Pakistan

About this study

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:

Read more

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).

Read the detailed description

Dental caries is a biofilm-mediated disease in which the progression of the carious lesion results in the demineralization and structural breakdown of dental hard tissues. Contemporary operative dentistry emphasizes minimally invasive management, with the selective removal of irreversibly damaged, infected dentin while preserving tissue that may remain structurally and biologically capable of repair. The choice of caries excavation technique may influence the amount of sound tooth structure removed, the mechanical stimulation of dentin, treatment time, and patient comfort.

Conventional rotary excavation is commonly performed using diamond or carbide burs. Although effective, rotary instrumentation may involve unnecessary removal of sound or potentially remineralizable dentin and can produce mechanical and thermal stimuli that may contribute to discomfort during treatment. Alternative excavation methods have therefore been developed to achieve more selective removal of carious tissue.

Smart polymer burs are designed to selectively remove softer, infected dentin while minimizing cutting of harder, sound dentin. The burs are manufactured from a polymer material with a hardness intermediate between infected and sound dentin. They are used at low rotational speed and are intended to reduce unnecessary removal of tooth structure. When the bur encounters harder dentin, its cutting efficiency is reduced, thereby supporting a more conservative excavation approach.

Carisolv is a chemomechanical caries-removal system. Its gel formulation contains sodium hypochlorite together with amino acids and is intended to soften altered carious dentin. Following chemical softening, the softened tissue is removed with appropriate hand instrumentation. The technique is based on selective removal of carious tissue rather than conventional high-speed mechanical cutting.

The present study is designed as a three-arm, parallel-group randomized clinical trial. After assessment and enrollment, participants will be allocated to one of three intervention groups using a simple randomization procedure. The intervention will be performed on the eligible carious tooth according to the assigned excavation technique. The same clinical operator or appropriately trained operator will follow a standardized protocol for the respective technique to minimize variation in treatment delivery.

For the Smart-bur group, carious dentin will be excavated using the designated polymer bur with a slow-speed handpiece according to the manufacturer's recommended operating conditions. For the Carisolv group, the Carisolv gel will be applied to the carious dentin according to the manufacturer's instructions, allowed to act on the affected tissue, and the softened carious material will subsequently be removed using suitable hand instruments. For the conventional group, caries will be excavated using conventional diamond burs with rotary instrumentation according to routine operative dentistry principles.

Radiographic and clinical assessment will be used before treatment to confirm the suitability of the selected tooth and to reduce the likelihood of including teeth with pulpal involvement. Treatment will be carried out under standardized clinical conditions. Participants will be monitored throughout the procedure, and the assigned excavation technique will be discontinued or modified if clinically indicated for patient safety or appropriate dental treatment.

Baseline demographic and relevant clinical information will be documented on a standardized data-collection form. Treatment allocation and study-related observations will be recorded by the research team under appropriate supervision. Data will subsequently be entered into a statistical database for analysis.

The principal analytical comparison will assess whether the three excavation techniques differ in the level of pain reported during the caries-removal procedure. Continuous variables will initially be summarized using appropriate descriptive statistics. Distributional assumptions will be assessed before selection of the final comparative statistical test. For normally distributed data, one-way analysis of variance will be used to compare the three independent groups. If the assumptions for parametric analysis are not satisfied, an appropriate non-parametric alternative will be considered. Statistical significance will be assessed at an alpha level of 0.05.

The study is intended to provide clinical evidence regarding the effect of different caries excavation approaches on patient comfort and to contribute to the evidence base for minimally invasive operative dentistry. The findings may help clinicians understand whether selective polymer-bur or chemomechanical excavation techniques provide a clinically meaningful difference in patient-reported discomfort compared with conventional rotary excavation.

Being tested
polymer burs, Carisolv, Conventional Diamond Burs
Keywords
Dental Caries, Caries excavation, Intraoperative pain, Pain perception, Smart polymer burs, Carisolv, Diamond burs, Minimally invasive dentistry, Chemomechanical caries removal, Operative dentistry, Caries removal techniques
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • polymer bursDevice

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

  • CarisolvDevice

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

  • Conventional Diamond BursDevice

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

Study groups in NCT07869407
Study groupRoleWhat they receive
Smart/Polymer BursExperimentalNot described
Receives: Device: polymer burs
CarisolvExperimentalNot described
Receives: Device: Carisolv
Conventional Diamond BursActive comparatorNot described
Receives: Device: Conventional Diamond Burs

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: immediately after completion of caries excavation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2026
  2. Study start1 Jul 2026
  3. Primary completion15 Jan 2027 (estimated)
  4. Study completion30 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07869407
Sponsor's protocol ID
smart burs
Status last verified
Jun 2026
First submitted
1 Oct 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared to protect participant privacy and confidentiality and in accordance with institutional ethical requirements. Only de-identified aggregate data will be reported.

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