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Trial record 82 of 1201 for:    tooth decay

Effectiveness of Modified Class IV Atraumatic Restorative Treatment (modARTIV)

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ClinicalTrials.gov Identifier: NCT02234609
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
PD Dr. A. Rainer Jordan, University of Witten/Herdecke

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.

Condition or disease Intervention/treatment Phase
Dental Caries Device: modified ART class IV Not Applicable

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."


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Modified Class IV Atraumatic Restorative Treatment - Results After 12 Months
Study Start Date : September 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
adults with incisor dental caries lesion
modified ART class IV with glass ionomer cement
Device: 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.




Primary Outcome Measures :
  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 [ Time Frame: 1 year ]
    Sept 2012 - Sept 2013: participants will be followed-up after 1 year


Secondary Outcome Measures :
  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 [ Time Frame: 1 year ]
    Sept 2012 - Sept 2013: participants will be followed-up after 1 year ART evaluation criteria were published as follows: "Frencken JF, Makoni F, Sithole W: Atraumatic Restorative Treatment and glas-ionomer sealants in a school oral health programme in Zimbabwe: Evaluation after 1 year. Caries Res 1996, 30:428-433". These index does clinically assess the dental restauration in 1 out of 9 categories from "excellent" to "restoration lost".



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • informed consent

Exclusion Criteria:

  • no class IV cavity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234609


Locations
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Gambia
public dental ward at Kindergarten Wattenscheid in Brikama-Kabafita, West Coast Region of The Republic of The Gambia
Banjul, Gambia
Sponsors and Collaborators
University of Witten/Herdecke
Investigators
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Study Chair: Stefan Zimmer, Professor Witten/Herdecke University

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Responsible Party: PD Dr. A. Rainer Jordan, Assistant Professor, University of Witten/Herdecke
ClinicalTrials.gov Identifier: NCT02234609     History of Changes
Other Study ID Numbers: mARTIV
76/2011 ( Other Identifier: Witten/Herdecke IRB )
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014

Keywords provided by PD Dr. A. Rainer Jordan, University of Witten/Herdecke:
dentistry
dental caries
atraumatic restorative Treatment
effectiveness

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases