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Clinical Trials/NCT04407520
NCT04407520
Completed
Not Applicable

Survival of Direct Composite Restorations Placed Under General Anesthesia in Adult Patients With Intellectual and/or Physical Disabilities and Risk Factors for Repeated Dental Treatment in General Anesthesia of Adult Patients With Intellectual and/or Physical Disabilities

University of Göttingen0 sites101 target enrollmentJanuary 21, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intellectual and/or Physical Disabilities
Sponsor
University of Göttingen
Enrollment
101
Primary Endpoint
Failure of restoration placed under general anesthesia
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The aim of this study is to assess the survival of direct anterior and/or posterior composite restoration placed in general anesthesia in permanent teeth of adult patients with intellectual and/or physical disabilities. Further aim is to identify potential risk factors predicting repeated dental treatment under general anesthesia.

Survival of composite restorations placed under general anesthesia in adult patients with intellectual and/or physical disabilities between 2011 and 2019 will be retrospectively analysed. Failure is defined as the need for replacement of at least one surface of the original restoration or extraction of the tooth. Individual-, tooth- and restoration-related factors are obtained from digital and paper-based dental records. Mean annual failure rates (mAFR) and median survival time will be calculated (Kaplan-Meier statistics). The effect of potential risk factors on failure will be tested using univariate log-rank tests and multivariate Cox-regression analysis.

Adult patients with intellectual and/or physical disabilities who received dental treatment under general anesthesia between 2011 and 2017 will be retrospectively analyzed. Demographic, anamnestic, oral health and treatment factors will be obtained from digital and paper-based dental records. Duration of intervals without a subsequent dental treatment under general anesthesia will be assessed using Kaplan-Meier statistics. Potential predictive factors will be tested using log-rank tests and multi-variate Cox-regression analysis.

Detailed Description

No patient treatment is associated with the study.

Registry
clinicaltrials.gov
Start Date
January 21, 2011
End Date
May 2020
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Göttingen
Responsible Party
Principal Investigator
Principal Investigator

Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic.

Senior Dental Practitioner

University Medical Center Goettingen

Eligibility Criteria

Inclusion Criteria

  • Adult patients with intellectual and/or physical disabilities that were treated under general anesthesia in the Department of Preventive Dentistry, Periodontology and Cariology between January 2011 and December 2019

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Failure of restoration placed under general anesthesia

Time Frame: 2011-2019

Failure is defined as the need for replacement of at least one surface of the original restoration or extraction of the tooth.

Secondary Outcomes

  • Repeated dental treatment under general anesthesia(2011-2017)

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