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Comparison of Smart Burs , Atraumatic Restorative Treatment and Gentle Hand Burs for Caries Removal in Children

Comparative Evaluation of Smart Burs,Atraumatic Restorative Treatment and Gentle Hand Burs for Caries Removal in Paediatric Patients: Randomised Controlled Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07857785
Enrollment
90
Registered
2026-10-05
Start date
2023-10-17
Completion date
2024-11-30
Last updated
2026-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries in Primary Molars in Children

Keywords

Atraumatic Restorative Treatment,Gentle Hand Burs,Smart Burs,Minimally Invasive Dentistry,Primary Molar Caries removal,Paediatric Dentistry

Brief summary

This study compared three gentle ways of removing tooth decay in children's primary molars:Gentle hand burs(new hand held rotary instrument used withot electricity),Smart burs (polymer burs used in a slow speed hand piece) and Atraumatic Restorative Treatment(removal with hand spoon excavator).Ninety children aged 5-11 years with a decayed occlusal surface on a primary molar were randomly assigned to one of the three methods.The study measured how completly decay was removed,how long removal took,how anxious the child was during treatment and how much pain the child reported afterwards.

Detailed description

Conventional high speed rotary caries removal can remove sound tooth structure,generate heat and aerosols and cause anxiety in children due to noise and vibration.Minimally invasive alternatives include Atraumatic Restorative Treament(ART) using hand excavators,self limiting polymer smart burs,and the recentl introduced Gentle Hand Burs ,which have an aluminium handle and long-shank carbide bur and need no electricity. This single center,parallel group,randomised controlled trial was conducted in the Department of paediatric and preventive dentistry,Meghna Institute of Dental sciences,Mallaram,Nizamabad,Telangana,India.Ninety children aged 5-11 years with occlusal caries lesions {ICDAS 4-6} in asymptomatic primary molars without pulpal involvement were allocated 1:1:1 by lottery method to ART,Gentle Hand Burs or Smart burs(30 per group).Sample size were calculated with alpha 0.05 and power 95%. Under rubber dam isolation, a caries-indicator dye was applied for 10 seconds and rinsed .Caries was removed by a single operator ; the end point was no catch with a straight explorer and no dye staining.Efficacy was scored with ericson's criteria,time was recorded,behaviour was rated by two examiners with the Sound,Eye,Motor(SEM) scale, and pain was self reported with the Wong Baker FACES Scale after treatment.Glass Ionomer Cement Restoration placed after excavation.

Interventions

DEVICEGentle Hand Burs

Caries removal done by manually operated instrument which is an aluminium handle and long shank carbide bur,without electricity or handpiece( Gerry Bueachmin,USA).

Caries removal with sharp spoon excavator without rotary instruments.

DEVICESmart Burs(polymer bur)

Self limiting polymer bur used in a slowspeed contra angle hand piece ,replaced when blunted.

Sponsors

Sathiraju Hema Sai Niharika
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
No

Inclusion criteria

1. Children aged 5 to 11 years 2. Atleast one active carious lesion on the occlusal surface of an asymptomatic primary molar 3. ICDAS score 4 to 6 4. Radiographic evidence of enamel and dentin involvement without pulpal involvement. 5. Written consent form from parent/guardian of child. -

Exclusion criteria

1)Pulpal exposure or bleeding during excavation 2)Tenderness to percussion 3)Non vital or grossly decayed teeth 4)Devlopmental anomalies such as fusion,gemination,dilaceration or amelogenesis imperfecta. \-

Design outcomes

Primary

MeasureTime frameDescription
Time taken for caries removal (efficiency)During the procedure (single visit)Time in minutes from the start of excavation to the clinical end-point ( no catch with explorer and no dye staining ), recorded with a stopwatch.
Efficacy of caries removalImmediately after excavation (single visit)Completeness of caries removal scored with Ericson's criteria (0 to 5;0=caries completly removed).

Secondary

MeasureTime frameDescription
Child behaviour during treatmentDuring the procedure (single visit).Sound,Eye,Motor (SEM) scale scores recorded by two calibrated examiners; higher scores mean more discomfort.
Pain perceptionImmediately after the procedure( sinle visit ).Wong Baker FACES Pain Rating Scale (0 to 10) self reported by the child;higher scores mean more pain.

Countries

India

Contacts

PRINCIPAL_INVESTIGATORSathiraju Hema Sai Niharika post graduate in paediatric and preventive dentistry, MDS

Meghna Institute of Dental Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 6, 2026