NCT07869407

Brief 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. 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Jul 2026Jan 2027

Study Start

First participant enrolled

July 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

October 9, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

October 1, 2026

Last Update Submit

October 7, 2026

Conditions

Pain During Caries Excavation

Keywords

Dental CariesCaries excavationIntraoperative painPain perceptionSmart polymer bursCarisolvDiamond bursMinimally invasive dentistryChemomechanical caries removalOperative dentistryCaries removal techniques

Outcome Measures

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.

    immediately after completion of caries excavation

Study Arms (3)

Smart/Polymer Burs

EXPERIMENTAL
Device: polymer burs

Carisolv

EXPERIMENTAL
Device: Carisolv

Conventional Diamond Burs

ACTIVE COMPARATOR
Device: Conventional Diamond Burs

Interventions

polymer bursDEVICE

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

Smart/Polymer Burs
CarisolvDEVICE

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

Carisolv
Conventional Diamond BursDEVICE

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

Conventional Diamond Burs

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Hypertension.
  • Severe periodontal disease.
  • Pregnancy.
  • Unwillingness or inability to provide informed consent/participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehman College of Dentistry

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Tehreema Naureen, Bachelor of Dental Surgery

    Rehman College of Dentistry, Peshawar

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tehreema Naureen, Bachelor of Dental Surgery

CONTACT

+923325566872tnaureen41@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Graduate Trainee

Study Record Dates

First Submitted

October 1, 2026

First Posted

October 9, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

January 30, 2027

Last Updated

October 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations

PA(1)