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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04407520
Enrollment
101
Registered
2020-05-29
Start date
2011-01-21
Completion date
2020-05-31
Last updated
2024-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Treatment Under General Anesthesia, Intellectual and/or Physical Disabilities

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.

Interventions

No patient treatment is associated with the study.

Sponsors

University of Göttingen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Failure of restoration placed under general anesthesia2011-2019Failure is defined as the need for replacement of at least one surface of the original restoration or extraction of the tooth.

Secondary

MeasureTime frame
Repeated dental treatment under general anesthesia2011-2017

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026