Effectiveness of Modified Class IV Atraumatic Restorative Treatment

NCT02234609 | Completed

• 2 other identifiers: mARTIV76/2011
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

dentistry; dental caries; atraumatic restorative Treatment; effectiveness

Outcome Measures

Primary Outcomes (1)

• Number (and percentage) of class IV modified ART restorations with failures after 1 year of performance (failures are defined as loss of restoration and/or fractures): annual failure rate

  Sept 2012 - Sept 2013: participants will be followed-up after 1 year

  1 year

Secondary Outcomes (1)

• 9 scale clinical evaluation scores of class IV modified ART restorations after 1 year of performance (scores are defined by Frencken et al. 1996): ART evaluation criteria

  1 year

Study Arms (1)

adults with incisor dental caries lesion

OTHER

modified ART class IV with glass ionomer cement

Device: modified ART class IV

Interventions

modified ART class IV 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.

adults with incisor dental caries lesion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent

You may not qualify if:

• no class IV cavity

Sponsors & Collaborators

• University of Witten/Herdecke: lead

Study Sites (1)

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

Banjul, The Gambia

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Stefan Zimmer, Professor

  Witten/Herdecke University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: September 9, 2014
• Study Start: September 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 10, 2014

Record last verified: 2014-09

Locations

TH (1)