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

• Sponsor: University of Göttingen (Other)
• Overall Status: Completed
• CT.gov ID: NCT04407520
• Collaborator: (none)
• Enrollment: 101
• Actual Duration (Months): 111.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intellectual and/or Physical Disabilities; Dental Treatment Under General Anesthesia	Other: No patient treatment is associated with the study

Detailed Description

No patient treatment is associated with the study.

Study Design

• Study Type: Observational
• Actual Enrollment: 101 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official 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
• Actual Study Start Date: Jan 21, 2011
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Adult patients with intellectual and/or physical disabilities Adult patients with intellectual and/or physical disabilities requiring dental treatment under general anesthesia	Other: No patient treatment is associated with the study; No patient treatment is associated with the study.

Outcome Measures

Primary Outcome Measures

1. Failure of restoration placed under general anesthesia [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 Outcome Measures

1. Repeated dental treatment under general anesthesia [2011-2017]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Göttingen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic., Senior Dental Practitioner, University Medical Center Goettingen
• ClinicalTrials.gov Identifier: NCT04407520
• Other Study ID Numbers: Survival-Disabled; 15/1/18
• First Posted: May 29, 2020
• Last Update Posted: Aug 27, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 27, 2021