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Effectiveness of Modified Class IV Atraumatic Restorative Treatment (modARTIV)

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Gambia
Study Type
Interventional
Intervention
modified ART class IV
Sponsored by
University of Witten/Herdecke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring dentistry, dental caries, atraumatic restorative Treatment, effectiveness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • informed consent

Exclusion Criteria:

  • no class IV cavity

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

adults with incisor dental caries lesion

Arm Description

modified ART class IV with glass ionomer cement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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".

Full Information

First Posted
August 25, 2014
Last Updated
September 9, 2014
Sponsor
University of Witten/Herdecke
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1. Study Identification

Unique Protocol Identification Number
NCT02234609
Brief Title
Effectiveness of Modified Class IV Atraumatic Restorative Treatment
Acronym
modARTIV
Official Title
Effectiveness of Modified Class IV Atraumatic Restorative Treatment - Results After 12 Months
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Witten/Herdecke

4. Oversight

Data Monitoring Committee
No

5. Study Description

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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
dentistry, dental caries, atraumatic restorative Treatment, effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
adults with incisor dental caries lesion
Arm Type
Other
Arm Description
modified ART class IV with glass ionomer cement
Intervention Type
Device
Intervention Name(s)
modified ART class IV
Intervention Description
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 Measure Information:
Title
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
Description
Sept 2012 - Sept 2013: participants will be followed-up after 1 year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
Description
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".
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: informed consent Exclusion Criteria: no class IV cavity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Zimmer, Professor
Organizational Affiliation
Witten/Herdecke University
Official's Role
Study Chair
Facility Information:
Facility Name
public dental ward at Kindergarten Wattenscheid in Brikama-Kabafita, West Coast Region of The Republic of The Gambia
City
Banjul
Country
Gambia

12. IPD Sharing Statement

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Effectiveness of Modified Class IV Atraumatic Restorative Treatment

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