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Clinical Trials/CTRI/2021/07/034545
CTRI/2021/07/034545Not yet recruitingPhase 3

Comparative evaluation of clinical and microbiological assessment of caries excavation using conventional bur, smart bur, chemomechanical method and ErCr:YSGG laser : An invivo study

Dr Prerana Kothari S1 site in 1 country60 target enrollmentStarted: July 20, 2021Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To compare the caries removal efficacy in terms of microbiological assessment and efficiency in terms of time taken by Tungsten Carbide No 330 bur,Polymer bur,Brix 3000 gel,Er:Cr:YSGG laser

Study Overview

Brief Summary

TITLE OF THE TOPIC: COMPARATIVE EVALUATION OF CLINICAL ANDMICROBIOLOGICAL ASSESSMENT OF CARIES EXCAVATION USING CONVENTIONAL BUR,SMARTBUR,CHEMOMECHANICAL METHOD AND ErCr:YSGG LASER : AN INVIVO STUDY.

Dental caries is the most prevalent chronic disease in the globalpopulation. It is characterised by the destruction of inorganic and dissolutionof organic material from tooth structure. The conventionaldentistry approach to caries treatment has been removing diseased tissue andreplacing it with a dental restorative material. Mechanical caries removaltraditionally involves the use of conventional tungsten carbide or round steelburs and hand instruments. The disadvantages of these methods are overpreparationof cavities, pain sensitivity and possible damage to the pulp. Since the dentistry has advanced so much in 21st centurythat G.V.Blacks “Extension for prevention†has transformed to “Prevention forExtension.†With the advent of adhesive materials and greaterunderstanding of the disease process we are moving into era of  Minimal intervention dentistry.Thenewer method for caries removal which follows the principle of minimallyinvasive dentistry has developed recently since last decades.These include laser, chemo-mechanicalmethod, air abrasion, air polishing, ultrasonic, ozone method, polymer burs andenzymes.

The aim of the study is to compare the cariesremoval efficacy in terms of microbiological assessment and efficiency in termsof time taken by Tungsten Carbide Bur No.330,Polymer bur,BRIX 3000 and ErCr:YSGG Laser.

INCLUSION CRITERIA:

1)Class 1 dentinal caries withbroad occlusal cavitated lesion on permanent molars. (2)Radiographically carious lesion has to be confined to outer dentin of occlusal surface. (3)Patient aged between 18-40 years old. (4)Teeth with intact buccal/lingual surface. 5)RDT ≥ 1.5 mm.

EXCLUSION CRITERIA:

1)Permanent molars with clinicaland radiological signs and symptoms of pulpal and periapical lesions. (2)Teeth with any developmentalanomaly. (3)Teeth with proximal caries andpulpal involvement. (4)Teeth with previous restorationand fractured crown. (5)Presence of white spot lesions. (6)Hypoplastic or hypomineralizedteeth.

A total of 60patients between the age group 18 to 40 years fulfilling the inclusion criteriawill be included in the study after obtaining informed consent. Before startingthe procedure, preoperative radiograph will be taken and RDT will bedetermined. All potential participants will be selected randomly and will bedivided into 4 groups depending on caries excavation methods. Rubber Dam will beused for isolation of the respective tooth. Local anesthesia will be given ifthe patient experiences pain or sensitivity during caries excavation. Cariesexcavation will be done with the following methods mentioned above. Time taken will bemeasured using a stopwatch from the beginning of caries removal to confirmationof complete excavation of caries clinically. For MicrobiologicalEvaluation two samples ofcarious material will be collected (one before caries excavation and one after)in Eppendorf tubes that contains saline. They will be transported to thelaboratory within 2 hrs. The samples will then be placed on blood agar plates andwill be incubated aerobically at 37ºC for 48 hrs. Using the Digital ColonyCounter total number of colonies formed will be determined and expressed asCFU/ml. Colony forming units per sample will be estimated before and after thetreatment and will then be processed according to S.O.P of RRMCH.

Study Design

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

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Class 1 dentinal caries with broad occlusal cavitated lesion on permanent molars.
  • Radiographically carious lesion has to be confined to outer dentin of occlusal surface.
  • Patient aged between 18-40 years old.
  • Teeth with intact buccal/lingual surface.
  • RDT ≥ 1.5 mm.

Exclusion Criteria

  • Permanent molars with clinical and radiological signs and symptoms of pulpal and periapical lesions.
  • Teeth with any developmental anomaly.
  • Teeth with proximal caries and pulpal involvement.
  • Teeth with previous restoration and fractured crown.
  • Presence of white spot lesions.

Outcomes

Primary Outcomes

To compare the caries removal efficacy in terms of microbiological assessment and efficiency in terms of time taken by Tungsten Carbide No 330 bur,Polymer bur,Brix 3000 gel,Er:Cr:YSGG laser

Time Frame: Patient recalled for the follow up appointments at 3,6 and 12 months

Secondary Outcomes

  • Good oral hygiene is achieved.(Patient recalled for the follow up appointments at 3,6 and 12 months)

Investigators

Sponsor
Dr Prerana Kothari S
Sponsor Class
Other [self]

Study Sites (1)

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