Ignite Creation Date:
2024-05-06 @ 7:36 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02569047
Status:
COMPLETED
Last Update Posted:
2019-08-29
First Post:
2015-09-28
Brief Title:
ART and Hall Technique for Management of Occlusal-proximal Caries in Primary Molars
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
ART and Hall Technique for the Management of Occlusal-proximal Caries in Primary Molars A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this two-arm parallel group patient-randomised controlled superiority trial is to evaluate the survival rate of approximal Atraumatic Restorative Treatment ART restorations compared to the Hall Technique HT placed in a school setting The investigators will recruit 120 schoolchildren 5-10 years with at least one occlusal-proximal carious lesion in primary molar They will be randomized and treated following best-practice protocols to either receive an ART restoration using the high-viscosity glass ionomer cement EQUIA Forte capsules GC Corp or a preformed metal crown placed using the HT 3M ESPE cemented with glass ionomer luting cement Fuji I Capsules GC Corp Baseline measures and outcome data at reviews over a three year period will be assessed through participant report clinical examination and parent report questionnaires
Detailed Description:
The selected children will be randomly allocated into 2 groups The control group will comprise cavities treated by ART following the protocol proposed by Frencken and Holmgren 1999 while the experimental group will comprise cavities treated by HT according to the guideline published by Innes and Evans 2011 The allocation of patients in each group will be carried out by a random list generated by a specific computer program To ensure the allocation concealment the sequence generated by randomization will be distributed in opaque sealed envelopes which will be opened by the operator during the treatment only after the patient is ready to receive treatment
Operators will be two undergraduate students in dentistry and one experienced specialist in pediatric dentistry that will be trained on how to prepare and fill the cavities according to the original procedures of ART Frencken and Holmgren 1999 and also according to HT Innes and Evans 2011 The training will include a lecture about the techniques used in this study as well as a workshop held in the laboratory for students to train handling and application of treatments to be tested They will also undergo a week of training with patients to apply the different techniques before starting the study the latter phase held at the Faculty of Dentistry University of São Paulo under the supervision of an experienced dentist in ART and HT
Each child will be allocated for one of the operators with the aid of a random list All treatments will be performed on the school premises in field conditions without the use of dental chair or other facilities from a clinical environment
Operators will be two undergraduate students in dentistry and one experienced specialist in pediatric dentistry that will be trained on how to prepare and fill the cavities according to the original procedures of ART Frencken and Holmgren 1999 and also according to HT Innes and Evans 2011 The training will include a lecture about the techniques used in this study as well as a workshop held in the laboratory for students to train handling and application of treatments to be tested They will also undergo a week of training with patients to apply the different techniques before starting the study the latter phase held at the Faculty of Dentistry University of São Paulo under the supervision of an experienced dentist in ART and HT
Each child will be allocated for one of the operators with the aid of a random list All treatments will be performed on the school premises in field conditions without the use of dental chair or other facilities from a clinical environment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None