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Comparing the clinical effectiveness and pain perception of a caries removal agent and mechanical caries removal method in Primary teeth

Comparison of clinical efficacy and pain perception with new chemomechanical caries removal agent and conventional caries removal method in primary molars : A randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/043848
Enrollment
60
Registered
2022-07-08
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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

Conditions

None listed

Interventions

Intervention1: BRIX3000: A new chemomechanical caries removal agent. It is a papain based agent which is encapsulated by using Encapsulating Buffer Emulsion (EBE) technology. Control Intervention1: Me

Sponsors

Dr Seema Bargale
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. children having occlusal carious lesion on maxillary and/or mandibular either first or second primary molar. 2. the teeth will be selected based on the Mount and Hume classification of 1.2 3. the children whose parents will give the written informed consent for study

Exclusion criteria

Exclusion criteria: 1. Children suffering from any illness requiring special medical care. 2. Children having teeth with pulp exposure, spontaneous pain, mobility, swelling or fistula next to the tooth, furcation or cervical lesion, and teeth with restorations, sealants or enamel defects

Design outcomes

Primary

MeasureTime frame
clinical efficacyTimepoint: this parameter will be assessed after the caries removal procedure—

Secondary

MeasureTime frame
pain perception using Wong-Baker faces pain rating scaleTimepoint: this parameter will be assessed after the caries removal procedure—

Countries

India

Contacts

Public ContactDr Seema Bargale

K M Shah Dental college and hospital, Sumandeep Vidyapeeth

drseemabargale@gmail.com7016048359

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026