Intellectual and/or Physical DisabilitiesNCT04407520
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
An observational study of Intellectual and/or Physical Disabilities and Dental Treatment Under General Anesthesia, run by University of Göttingen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intellectual and/or Physical Disabilities, Dental Treatment Under General Anesthesia
- What is being tested?
- No patient treatment is associated with the study
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- 21 Jan 2011to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with intellectual and/or physical disabilities and need for dental treatment under general anesthesia.
Who may be able to join
- 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
Who cannot join
- none
About this study
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
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.
Read the detailed description
No patient treatment is associated with the study.
- Being tested
- No patient treatment is associated with the study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No patient treatment is associated with the studyOther
No patient treatment is associated with the study.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with intellectual and/or physical disabilities | Adult patients with intellectual and/or physical disabilities requiring dental treatment under general anesthesia Receives: Other: No patient treatment is associated with the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of restoration placed under general anesthesia
Failure is defined as the need for replacement of at least one surface of the original restoration or extraction of the tooth.
Measured: 2011-2019
Secondary outcomes (1)
Repeated dental treatment under general anesthesia
Measured: 2011-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start21 Jan 2011
- Primary completion31 Dec 2019
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intellectual and/or Physical DisabilitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic., University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407520
- Sponsor's protocol ID
- Survival-Disabled
- Other IDs
- 15/1/18
- Status last verified
- Feb 2024
- First submitted
- 25 May 2020
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33449193Maes 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.
PubMed 34432139
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04407520
- Acronym / sponsor ID
- Survival-Disabled
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Study start
- 21 Jan 2011 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with intellectual and/or physical disabilities | – | Other: No patient treatment is associated with the studyAdult patients with intellectual and/or physical disabilities requiring dental treatment under general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with intellectual and/or physical disabilities and need for dental treatment under general anesthesia.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No patient treatment is associated with the studyNo patient treatment is associated with the study. | Other | Adult patients with intellectual and/or physical disabilities |
Primary outcome
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.
1 secondary outcome
Repeated dental treatment under general anesthesia
Time frame: 2011-2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Results publication: PubMed 33449193Maes 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.
- Results publication: PubMed 34432139Maes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intellectual and/or Physical Disabilities and Dental Treatment Under General Anesthesia, run by University of Göttingen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of restoration placed under general anesthesia (time frame: 2011-2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04407520, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.