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OpenTrials
Completed

NCT Number: NCT04407520

Retrospective Database Study: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

No patient treatment is associated with the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • none

Treatment and study plan

No patient treatment is associated with the study

Other

No patient treatment is associated with the study.

Primary outcomes

  1. 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

  1. Repeated dental treatment under general anesthesia

    Time frame: 2011-2017

Sponsors and collaborators

Lead sponsor

University of Göttingen

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2019
Study completion
2020
First posted
May 29, 2020
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.