Chemomechanical Caries Removal Using Papain Gel

Chemomechanical Caries Removal Using a Papain-Based Gel: A Randomized Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01811420

Acronym

CMCR09

Enrollment

Registered

2013-03-14

Start date

2009-03-31

Completion date

2011-03-31

Last updated

2013-03-14

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

Conditions

Dental Caries

Keywords

dental caries, caries removal, chemomechanical caries removal

Brief summary

To evaluate the efficacy of a papain-based gel in caries removal.

Detailed description

Twenty children with at least two carious molar teeth without pulpal involvement participated in this randomized clinical trial. A total of 40 teeth were randomly divided into two treatment groups: group A, papain-based gel; and group B, conventional technique. Data collection included the time required for caries removal, need for local anesthesia, degree of discomfort, changes in the number of viable bacteria, and clinical evaluation of glass ionomer-cement restorations 6-month post-treatment.

Interventions

PROCEDUREChemomechanical Caries Removal

Chemomechanical Caries Removal Using A Papain-Based Gel

PROCEDUREConventional method

Dental caries removal using rotatory instrument

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

4 Years to 6 Years

Healthy volunteers

Yes

Inclusion criteria

* Children with active caries without pulpal involvement in two deciduous molar teeth participated in the trial. * The caries were located on the occlusal surface.

Exclusion criteria

* Children with pathological process of the dental tissue, with pulpal involvement

Design outcomes

Primary

Measure	Time frame	Description
restauration evaluation	18 months	the restauration will be assessed by clinical examination for detection the current caries

Secondary

Measure	Time frame	Description
discomfort or pain	6 months	The Faces Pain Scale was used to evaluate the need for local anesthesia during the procedure. The child was asked to choose a face matching the intensity of his or her pain experience during the procedure.

Other

Measure	Time frame	Description
radiographic status	18 months	the restauration will be assessed by radiographic examination for detection the current caries

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026