Effectiveness of Modified Class IV Atraumatic Restorative Treatment

NCT ID: NCT02234609

Last Updated: 2014-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-10-31

Brief Summary

Atraumatic Restorative Treatment (ART) has become an accepted dental restoration treatment in many developing countries. Because, ART is intended to be operated in molars, and about 10% of all carious lesion by an age of 18 years appear in anterior teeth in Gambia, it was the aim of this study to clinically evaluate a modified ART restoration technique for anterior teeth as the traditional treatment approach did not show satisfying clinical results.

Detailed Description

Atraumatic Restorative Treatment (ART) has become an evidence-based treatment in class I caries cavities for countries with developing dental infrastructure. Though epidemiological data also demonstrate restorative treatment needs in anterior teeth in several African countries, scientific evidence for ART in this application appeared so far unrewarding. Consequently, many carious teeth remain untreated or are scheduled for extraction. In deciduous teeth, class III and IV ART presented 86% failures due to partial or complete loss already within the first year, and longitudinal data in the permanent dentition are rare. Survival rates of 71% after three years, and of 68% after six years in the same study cohort were reported from Brazil.

Basically, ART appears to be an interesting treatment approach as it combines a manual cavity preparation technique with the use of a glass-ionomer cement as an adhesive and fluoride releasing restoration material. Biomechanical stress, however, is above-average in class IV restorations when intending to reconstruct the incisal edge with glass-ionomer cement resulting in reported high rates of restoration fractures or loss. It was therefore the aim to evaluate the clinical effectiveness of a modified ART class IV restoration technique in a clinical study. These data are to be compared with an historical control (original ART class IV anatomical structure rebuilding restorations). Historical control data will be retrieved from "Jordan RA, Gaengler P, Markovic L, Zimmer S: Performance of Atraumatic Restorative Tratment (ART) depending on operator-experience. J Public Health Dent 2010; 70: 176-80."

Conditions

Dental Caries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

adults with incisor dental caries lesion

modified ART class IV with glass ionomer cement

Group Type: OTHER

modified ART class IV

Intervention Type: DEVICE

Carious tissue was removed with an excavator until a sound probing was obtained. Restorations were performed using a mechanically improved glass-ionomer cement for ART. The modified class IV ART restoration was inserted into the cavity using a spatula. By these restoration technique, the cavity was (i) sealed to stop further caries progression. The cavity was (ii) capped to protect the vital dentin-pulp-complex from external stimuli. The modified class IV ART was aimed at conserving the carious incisor for prospective functional use and for prolonging tooth preservation rather than at anatomical reconstruction of the tooth form for cosmetic reasons.

Interventions

modified ART class IV

Carious tissue was removed with an excavator until a sound probing was obtained. Restorations were performed using a mechanically improved glass-ionomer cement for ART. The modified class IV ART restoration was inserted into the cavity using a spatula. By these restoration technique, the cavity was (i) sealed to stop further caries progression. The cavity was (ii) capped to protect the vital dentin-pulp-complex from external stimuli. The modified class IV ART was aimed at conserving the carious incisor for prospective functional use and for prolonging tooth preservation rather than at anatomical reconstruction of the tooth form for cosmetic reasons.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• informed consent

Exclusion Criteria

• no class IV cavity

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Witten/Herdecke

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. A. Rainer Jordan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Zimmer, Professor

Role: STUDY_CHAIR

Witten/Herdecke University

Locations

public dental ward at Kindergarten Wattenscheid in Brikama-Kabafita, West Coast Region of The Republic of The Gambia

Banjul, , The Gambia

Countries

The Gambia

Other Identifiers

76/2011

Identifier Type: OTHER

Identifier Source: secondary_id

mARTIV

Identifier Type: -

Identifier Source: org_study_id