ART and Hall Technique for Management of Occlusal-proximal Caries in Primary Molars

NCT02569047 | Completed

• 1 other identifier: HALLART
• Study Type: interventional
• Target: 131
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries

Keywords

Atraumatic Restorative Treatment; Occlusoproximal; Primary Teeth; Glass Ionomer Cements; Hall Technique

Outcome Measures

Primary Outcomes (1)

• The restoration survival (changes from baseline up to 36 months)

  The treatments will be classified "success" when they present clinical satisfactory aspect, and the failures will be scored as "minor failures" and "major failures" (adapted from Innes et al., 2007). The minor failures will be those in which there is a defect in the restoration / crown, but it does not interfere with the tooth health. The major failures will be considered when there signs or symptoms of irreversible pulp damage, such as dental fistula / abscess, tooth fracture or failures that cannot be repaired .The ART-restorations and HT scored as satisfactory will be considered as "successful", while those presented minor and major failures will be considered as "failure".

  The treatments will be evaluated after 1 week up to 36 months

Secondary Outcomes (7)

• Child self-reported discomfort

  Baseline

• Perception and concerns related to tooth appearance.

  baseline up to 6 months

• Acceptance of children in relation to treatments performed.

  Immediately after treatment (in the same appointment)

• Acceptance of parents in relation to treatments performed.

  Immediately after treatment (in the same appointment)

• Occlusal vertical dimension assessment

  The measurements will be done before treatment, immediately after treatment (in the same appointment) and at each check-up appointment (1, 2 and 3 weeks and 1, 6, 12, 18, 24, 30 and 36 months)

Study Arms (2)

Atraumatic Restorative Treatment

ACTIVE COMPARATOR

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.

Procedure: Atraumatic Restorative Treatment

Hall Technique

EXPERIMENTAL

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.

Procedure: Hall Technique

Interventions

Atraumatic Restorative Treatment 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.

Also known as: Equia Forte

Atraumatic Restorative Treatment

Hall Technique 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.

Also known as: Metal Crowns

Hall Technique

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• University of Dundee: collaborator
• Academic Centre for Dentistry in Amsterdam: collaborator

Related Publications (48)

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  PMID: 40830451 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.

  PMID: 33176756 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.

  PMID: 27029801 DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Dental Atraumatic Restorative Treatment

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Daniela P Raggio, Professor

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 6, 2015
• Study Start: October 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: August 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share