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

NCT ID: NCT04407520

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-21

Study Completion Date

2020-05-31

Brief Summary

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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

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No patient treatment is associated with the study.

Conditions

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Intellectual and/or Physical Disabilities Dental Treatment Under General Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Adult patients with intellectual and/or physical disabilities

Adult patients with intellectual and/or physical disabilities requiring dental treatment under general anesthesia

No patient treatment is associated with the study

Intervention Type OTHER

No patient treatment is associated with the study.

Interventions

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No patient treatment is associated with the study

No patient treatment is associated with the study.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Göttingen

OTHER

Sponsor Role lead

Responsible Party

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

Senior Dental Practitioner

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Maes MS, Kanzow P, Hrasky V, Wiegand A. Survival of direct composite restorations placed under general anesthesia in adult patients with intellectual and/or physical disabilities. Clin Oral Investig. 2021 Jul;25(7):4563-4569. doi: 10.1007/s00784-020-03770-y. Epub 2021 Jan 15.

Reference Type RESULT
PMID: 33449193 (View on PubMed)

Maes MS, Kanzow P, Biermann J, Leha A, Hrasky V, Wiegand A. Risk factors for repeated general anesthesia for dental treatment of adult patients with intellectual and/or physical disabilities. Clin Oral Investig. 2022 Feb;26(2):1695-1700. doi: 10.1007/s00784-021-04142-w. Epub 2021 Aug 25.

Reference Type RESULT
PMID: 34432139 (View on PubMed)

Other Identifiers

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15/1/18

Identifier Type: OTHER

Identifier Source: secondary_id

Survival-Disabled

Identifier Type: -

Identifier Source: org_study_id

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