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Randomized controlled clinical trial of long-term chemo-mechanical caries removal using Papacarie™ gel.

Motta LJ, Bussadori SK, Campanelli AP, Silva AL, Alfaya TA, Godoy CH, Navarro MF - J Appl Oral Sci (2014 Jul-Aug)

Bottom Line: No statistically significant difference between groups was found regarding the time required to perform the procedures and the radiographic follow up.Statistically significant differences between groups were found in the clinical evaluation at 6 and 18 months after treatment.Papacarie™ is as effective as the traditional method for the removal of carious dentin on deciduous teeth, but offers the advantages of the preservation of sound dental tissue as well as the avoidance of sharp rotary instruments and local anesthesia.

View Article: PubMed Central - PubMed

Affiliation: School of Dentistry, University Nove de Julho, São Paulo, SP, Brazil.

ABSTRACT

Objectives: Compare the effectiveness of Papacarie™ gel for the chemo-mechanical removal of carious lesions on primary teeth to conventional caries removal with a low-speed bur with regard to execution time, clinical aspects and radiographic findings.

Material and methods: A randomized controlled clinical trial with a split-mouth design was carried out. The sample was composed of 20 children aged four to seven years, in whom 40 deciduous teeth were randomly divided into two groups: chemo-mechanical caries removal with Papacarie™ and removal of carious dentin with a low-speed bur. Each child underwent both procedures and served as his/her own control. Restorations were performed with glass ionomer cement. The time required to perform the procedure was also analyzed. The patients underwent longitudinal clinical and radiographic follow-up of the restorations.

Results: No statistically significant difference between groups was found regarding the time required to perform the procedures and the radiographic follow up. Statistically significant differences between groups were found in the clinical evaluation at 6 and 18 months after treatment.

Conclusion: Papacarie™ is as effective as the traditional method for the removal of carious dentin on deciduous teeth, but offers the advantages of the preservation of sound dental tissue as well as the avoidance of sharp rotary instruments and local anesthesia.

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Related in: MedlinePlus

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f01: Flowchart of the protocol

Mentions: A randomized, controlled, clinical trial with a "split-mouth" design was carried out toassess the efficacy of PapacarieTM gel. The investigation was designed,analyzed and interpreted according to the Consolidated Standards of Reporting Trials(CONSORT) (Figure 1). Thirty children aged four toseven years who sought dental treatment at the Pediatric Dentistry Clinic of theUniversity Nove de Julho (Brazil) were recruited. The control group was submitted to thetraditional method (bur) for the removal of carious tissue. All parents/guardiansreceived information on the objectives and procedures of the study and signed astatement of informed consent in compliance with Resolution 196/96 of the BrazilianNational Health Board. This study received approval from the Human Research EthicsCommittee of the University Nove de Julho (Brazil) under process nº 219047. The clinicaltrial registration number is NCT01811420.


Randomized controlled clinical trial of long-term chemo-mechanical caries removal using Papacarie™ gel.

Motta LJ, Bussadori SK, Campanelli AP, Silva AL, Alfaya TA, Godoy CH, Navarro MF - J Appl Oral Sci (2014 Jul-Aug)

Flowchart of the protocol
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4126827&req=5

f01: Flowchart of the protocol
Mentions: A randomized, controlled, clinical trial with a "split-mouth" design was carried out toassess the efficacy of PapacarieTM gel. The investigation was designed,analyzed and interpreted according to the Consolidated Standards of Reporting Trials(CONSORT) (Figure 1). Thirty children aged four toseven years who sought dental treatment at the Pediatric Dentistry Clinic of theUniversity Nove de Julho (Brazil) were recruited. The control group was submitted to thetraditional method (bur) for the removal of carious tissue. All parents/guardiansreceived information on the objectives and procedures of the study and signed astatement of informed consent in compliance with Resolution 196/96 of the BrazilianNational Health Board. This study received approval from the Human Research EthicsCommittee of the University Nove de Julho (Brazil) under process nº 219047. The clinicaltrial registration number is NCT01811420.

Bottom Line: No statistically significant difference between groups was found regarding the time required to perform the procedures and the radiographic follow up.Statistically significant differences between groups were found in the clinical evaluation at 6 and 18 months after treatment.Papacarie™ is as effective as the traditional method for the removal of carious dentin on deciduous teeth, but offers the advantages of the preservation of sound dental tissue as well as the avoidance of sharp rotary instruments and local anesthesia.

View Article: PubMed Central - PubMed

Affiliation: School of Dentistry, University Nove de Julho, São Paulo, SP, Brazil.

ABSTRACT

Objectives: Compare the effectiveness of Papacarie™ gel for the chemo-mechanical removal of carious lesions on primary teeth to conventional caries removal with a low-speed bur with regard to execution time, clinical aspects and radiographic findings.

Material and methods: A randomized controlled clinical trial with a split-mouth design was carried out. The sample was composed of 20 children aged four to seven years, in whom 40 deciduous teeth were randomly divided into two groups: chemo-mechanical caries removal with Papacarie™ and removal of carious dentin with a low-speed bur. Each child underwent both procedures and served as his/her own control. Restorations were performed with glass ionomer cement. The time required to perform the procedure was also analyzed. The patients underwent longitudinal clinical and radiographic follow-up of the restorations.

Results: No statistically significant difference between groups was found regarding the time required to perform the procedures and the radiographic follow up. Statistically significant differences between groups were found in the clinical evaluation at 6 and 18 months after treatment.

Conclusion: Papacarie™ is as effective as the traditional method for the removal of carious dentin on deciduous teeth, but offers the advantages of the preservation of sound dental tissue as well as the avoidance of sharp rotary instruments and local anesthesia.

Show MeSH
Related in: MedlinePlus