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Clinical Trials/CTRI/2024/10/075708
CTRI/2024/10/075708Not yet recruitingNot Applicable

COMPARATIVE EVALUATION OF THE EFFICACY OF BRIX3000, SMART BURS, AND CONVENTIONAL METHOD IN CARIES EXCAVATION.

Akanksha shah1 site in 1 country66 target enrollmentStarted: November 11, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
66
Locations
1
Primary Endpoint
Colony forming unit will be checked to determine the efficacy of caries removal of these products

Study Overview

Brief Summary

In this era of “Minimal Invasive Dentistry” preserving tooth structure, is increasingly becoming a standard in dental practice.  Conventional caries removal and cavity preparation entails the use of high-speed handpiece and burs which undoubtedly improved the speed and efficiency of cavity preparation but has many inevitable disadvantages. To overcome these, various newer caries excavation techniques have been suggested like air abrasion, air polishing, ultrasonic, Sono abrasion, lasers and the chemomechanical caries removal technique.

Chemomechanical caries removal (CMCR) is a non-invasive technique of removal of caries via eliminating infected dentin. BRIX-3000, papain-based chemical mechanical agent, with a proteolytic enzyme obtained from leaves latex and fruits of green papaya (Carica Papaya) that acts as a chemical debriding agent.

Another minimally invasive method of caries removal is by using polymer burs. The cutting edges will wear down in contact with harder materials, such as healthy dentin.

The recruited patients will be distributed equally into three groups

ü  Group I – Conventional method (n=22)

ü  Group II – BRIX3000 (n=22)

ü  Group III - Smart Burs (n=22)

Caries excavation will be done with respective agents, and the working time will be calculated. Microbial analysis will be carried out, thus all the samples will be evaluated for a total reduction in the bacterial count (CFU) and mean working time

study hypothesis is that minimal invasive technique can prove that they can effectively remove all the caries as well preserve tooth structure

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Wide Class 1 deep carious lesion on permanent molars 2.No pulpal involvement as evident on a radiograph 3.Good oral hygiene 4.Patient willing for voluntary participation and have signed the informed consent.

Exclusion Criteria

  • 1.Pulpal exposure or bleeding during the excavation procedure 2.Patients with underlying systemic diseases.
  • 3.Teeth with any developmental anomalies 4.Teeth with any previous restorations.

Outcomes

Primary Outcomes

Colony forming unit will be checked to determine the efficacy of caries removal of these products

Time Frame: 1 week

Secondary Outcomes

  • Shapiro Wilk test will be used to check which all variables will follow normal distribution(colony forming units will be calculated to determine the most efficient method)

Investigators

Sponsor
Akanksha shah
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Akanksha shah

H.K.E. SOCIETY’S S. NIJALINGAPPA INSTITUTE OF DENTAL SCIENCES AND RESEARCH, KALABURAGI- 585105.

Study Sites (1)

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