ART and Hall Technique for Management of Occlusal-proximal Caries in Primary Molars
NCT ID: NCT02569047
Last Updated: 2019-08-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
131 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-10-31
Study Completion Date
2018-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Dental Caries
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Atraumatic Restorative Treatment
The cavity will be prepared according to the ART (Atraumatic Restorative Treatments) steps and filled with the dental material Glass Ionomer Cement without local anesthesia.
Group Type
ACTIVE_COMPARATOR
Atraumatic Restorative Treatment
Intervention Type
PROCEDURE
No local anaesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with Glass Ionomer Cement (GIC).The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed.
Hall Technique
The cavity will not receive any preparation. A stainless crown will be placed and cemented with the dental material Glass Ionomer Cement without local anesthesia.
Group Type
EXPERIMENTAL
Hall Technique
Intervention Type
PROCEDURE
It employs the cementation of preformed metal crowns (PMC) without the need of any prior teeth preparation or caries removal. No local anesthesia is used neither tooth preparation.Different sizes of PMCs will be tested until the smallest size that perfectly fit the tooth is achieved. The PMC will be loaded with the dental material glass ionomer cement (GIC) and placed. Child will asked to bite firmly on it, until it is fitted. The excess of GIC will be removed with hand instruments and dental floss.
Interventions
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Atraumatic Restorative Treatment
No local anaesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with Glass Ionomer Cement (GIC).The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed.
Intervention Type
PROCEDURE
Hall Technique
It employs the cementation of preformed metal crowns (PMC) without the need of any prior teeth preparation or caries removal. No local anesthesia is used neither tooth preparation.Different sizes of PMCs will be tested until the smallest size that perfectly fit the tooth is achieved. The PMC will be loaded with the dental material glass ionomer cement (GIC) and placed. Child will asked to bite firmly on it, until it is fitted. The excess of GIC will be removed with hand instruments and dental floss.
Intervention Type
PROCEDURE
Other Intervention Names
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Equia Forte
Metal Crowns
Eligibility Criteria
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Inclusion Criteria
* children aged between 5 and 10 years
* cooperative behavior
* presenting good health conditions
* whose parents or legal guardians accept and sign the consent form
* with at least one occluso-proximal lesion in primary molar
* only occlusal-proximal surfaces with caries lesions with dentin involvement
* cavities accessible to hand instruments used in ART
* absence of fistula or abscess near the selected tooth
* absence of pulp exposure in the selected tooth
* absence of mobility in the selected tooth
* cavity size in the selected tooth not be bigger than 2.0 mm in the mesial-distal and 2.5 in the occlusal-cervical and bucco-lingual directions.
* cooperative behavior
* presenting good health conditions
* whose parents or legal guardians accept and sign the consent form
* with at least one occluso-proximal lesion in primary molar
* only occlusal-proximal surfaces with caries lesions with dentin involvement
* cavities accessible to hand instruments used in ART
* absence of fistula or abscess near the selected tooth
* absence of pulp exposure in the selected tooth
* absence of mobility in the selected tooth
* cavity size in the selected tooth not be bigger than 2.0 mm in the mesial-distal and 2.5 in the occlusal-cervical and bucco-lingual directions.
Exclusion Criteria
* children younger than 5 years and older than 10
* non-cooperative behavior
* without good health conditions
* whose parents or legal guardians did not accepted and signed the consent form
* without any occluso-proximal lesion in primary molar
* caries in the selected tooth reaching other surfaces (than occlusal-proximal surface)
* occlusal-proximal surface with caries without dentin involvement
* cavities not accessible to hand instruments
* fistula or abscess near the selected tooth
* pulp exposure in the selected tooth
* mobility in the selected tooth
* cavity size bigger than 2.0 mm in the mesial-distal and 2.5 in the occlusal-cervical and - bucco-lingual directions.
* non-cooperative behavior
* without good health conditions
* whose parents or legal guardians did not accepted and signed the consent form
* without any occluso-proximal lesion in primary molar
* caries in the selected tooth reaching other surfaces (than occlusal-proximal surface)
* occlusal-proximal surface with caries without dentin involvement
* cavities not accessible to hand instruments
* fistula or abscess near the selected tooth
* pulp exposure in the selected tooth
* mobility in the selected tooth
* cavity size bigger than 2.0 mm in the mesial-distal and 2.5 in the occlusal-cervical and - bucco-lingual directions.
Minimum Eligible Age
5 Years
Maximum Eligible Age
10 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Dundee
OTHER
Sponsor Role
collaborator
Academic Centre for Dentistry in Amsterdam
OTHER
Sponsor Role
collaborator
University of Sao Paulo
OTHER
Sponsor Role
lead
Responsible Party
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Daniela Prócida Raggio
Associated Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Daniela P Raggio, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
References
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de Araujo MP, Garbim JR, Innes NP, Hesse D, Bonifacio CC, Olegario IC, Braga MM, Mendes FM, Raggio DP. Economic Evaluation of ART and Hall in Primary Molars. BMC Oral Health. 2025 Aug 19;25(1):1336. doi: 10.1186/s12903-025-06528-8.
Reference Type
DERIVED
Araujo MP, Innes NP, Bonifacio CC, Hesse D, Olegario IC, Mendes FM, Raggio DP. Atraumatic restorative treatment compared to the Hall Technique for occluso-proximal carious lesions in primary molars; 36-month follow-up of a randomised control trial in a school setting. BMC Oral Health. 2020 Nov 11;20(1):318. doi: 10.1186/s12903-020-01298-x.
Reference Type
DERIVED
Hesse D, de Araujo MP, Olegario IC, Innes N, Raggio DP, Bonifacio CC. Atraumatic Restorative Treatment compared to the Hall Technique for occluso-proximal cavities in primary molars: study protocol for a randomized controlled trial. Trials. 2016 Mar 31;17:169. doi: 10.1186/s13063-016-1270-z.
Reference Type
DERIVED
Other Identifiers
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HALLART
Identifier Type: -
Identifier Source: org_study_id
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