Prosthesis Failure, DentalNCT04884126
Customized Oral and Maxillofacial Reconstruction
An observational study of Prosthesis Failure, Dental and Dental Implant Failed, run by KU Leuven.
Trial summary
Regional oral and maxillofacial defects secondary to ablative tissue resection can contribute to severe aesthetic and functional loss, which influences patients' regular life and may cause psychological problems. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Prosthesis Failure, Dental, Dental Implant Failed
- What is being tested?
- dental implant placement
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1996to 1 Dec 2021
- How long will I take part?
- 12 Months
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The files of patients diagnosed and treated between December 2004 and January 2020 for defect of dentition secondary to jaw resection were retrospectively reviewed. The patients who underwent dental implant surgery after ablative tumor resection with segmental mandibulectomy and vascularized bone flap graft were retrieved from the database.
Who may be able to join
- 1. Patients with grafted bone (fibula, iliac, scapula) and receive postoperative implant surgery.
- 2.Clinical and radiogram data were available for all treatment periods and follow-up visits (Pre-/post-CBCT and panoramic radiographs).
- 3.Over twelve months follow-up period after implant placement. 4.Age > 18 years. 5.Fabrication and delivery of prosthesis following implant installation. 6.Treatment with a one-stage/two-stage surgical protocol.
Who cannot join
- Patients diagnosed with osteoporosis.
- Lost or missing medical history during follow-up period.
- Follow-up period of dental implants was less than 12 months.
About this study
Official title: Accuracy, Fitness, Compatibility, and Clinical Outcomes of Customized Implants and Prosthesis in Oral and Maxillofacial Reconstruction
Regional oral and maxillofacial defects secondary to ablative tissue resection can contribute to severe aesthetic and functional loss, which influences patients' regular life and may cause psychological problems. Microvascular free flaps are considered the gold standard for reconstructing large oral and maxillofacial defects. In the past decade, with the help of computer-aided design (CAD)/ computer-aided manufacturing (CAM) customized implants and prosthesis (CIP) have led to a significant improvement of the operative accuracy, improve the flap survival rate and enhance the patients' quality of life.
Concerning the increased overall survival rate of the patients, people pay more attention to the quality of life and aesthetic appearance which are influenced by the fitness and compatibility of the CIP. However, from literature reviews, the evaluation was various to be concluded in some certain conditions from pooled studies.
Read the detailed description
The trial will be conducted in compliance with the principles of the Declaration of Helsinki (specifying which amendment), the principles of GCP, and all of the applicable regulatory requirements. This protocol and related documents will the for review to the Ethics Committee. The Investigator and the Participating Site shall treat all information and data relating to the Study disclosed to Participating Site and/or Investigator in this Study as confidential and shall not disclose such information to any third parties or use such information for any purpose other than the performance of the Study. The collection, processing, and disclosure of personal data, such as patient health and medical information is subject to compliance with applicable personal data protection and the processing of personal data (Directive 95/46/EC and Belgian law of December 8, 1992, on the Protection of the Privacy in relation to the Processing of Personal Data). The extracted data will be encoded, the subject's EAD-number will be stored separately(site file) from the research data and replaced with a unique study ID-code to create a new identity for the subject. The file containing the patient-specific EAD-numbers will be kept on a secured UZ Leuven servers.
- Conditions
- Prosthesis Failure, Dental, Dental Implant Failed
- Being tested
- dental implant placement
- Keywords
- Dental Implants, Mandibular Reconstruction, Mouth Rehabilitation
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implant placementProcedure or surgery
The time of dental implant surgery
| Study group | Role | What they receive |
|---|---|---|
| One stage dental implants placement | Not described Receives: Procedure: dental implant placement | |
| Second stage dental implants placement | Not described Receives: Procedure: dental implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The survival rate of the dental implants
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Jan 1996
- Primary completion1 May 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis Failure, DentalStudies 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
- Cross-sectional
- Enrolment
- 150 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongyang Ma, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884126
- Sponsor's protocol ID
- S63615
- Status last verified
- Nov 2022
- First submitted
- 6 May 2021
- Last updated
- 21 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy, Fitness, Compatibility, and Clinical Outcomes of Customized Implants and Prosthesis in Oral and Maxillofacial Reconstruction
- ClinicalTrials.gov ID
- NCT04884126
- Acronym / sponsor ID
- S63615
- Conditions
- Prosthesis Failure, Dental, Dental Implant Failed
- Keywords
- Dental Implants, Mandibular Reconstruction, Mouth Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jan 1996 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 12 May 2021 (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.
Regional oral and maxillofacial defects secondary to ablative tissue resection can contribute to severe aesthetic and functional loss, which influences patients' regular life and may cause psychological problems. Microvascular free flaps are considered the gold standard for reconstructing large oral and maxillofacial defects. In the past decade, with the help of computer-aided design (CAD)/ computer-aided manufacturing (CAM) customized implants and prosthesis (CIP) have led to a significant improvement of the operative accuracy, improve the flap survival rate and enhance the patients' quality of life.
Concerning the increased overall survival rate of the patients, people pay more attention to the quality of life and aesthetic appearance which are influenced by the fitness and compatibility of the CIP. However, from literature reviews, the evaluation was various to be concluded in some certain conditions from pooled studies.
Detailed description
The trial will be conducted in compliance with the principles of the Declaration of Helsinki (specifying which amendment), the principles of GCP, and all of the applicable regulatory requirements. This protocol and related documents will the for review to the Ethics Committee. The Investigator and the Participating Site shall treat all information and data relating to the Study disclosed to Participating Site and/or Investigator in this Study as confidential and shall not disclose such information to any third parties or use such information for any purpose other than the performance of the Study. The collection, processing, and disclosure of personal data, such as patient health and medical information is subject to compliance with applicable personal data protection and the processing of personal data (Directive 95/46/EC and Belgian law of December 8, 1992, on the Protection of the Privacy in relation to the Processing of Personal Data). The extracted data will be encoded, the subject's EAD-number will be stored separately(site file) from the research data and replaced with a unique study ID-code to create a new identity for the subject. The file containing the patient-specific EAD-numbers will be kept on a secured UZ Leuven servers.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One stage dental implants placement | – | Procedure: dental implant placement |
| Second stage dental implants placement | – | Procedure: dental implant placement |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The files of patients diagnosed and treated between December 2004 and January 2020 for defect of dentition secondary to jaw resection were retrospectively reviewed. The patients who underwent dental implant surgery after ablative tumor resection with segmental mandibulectomy and vascularized bone flap graft were retrieved from the database.
Key inclusion criteria (3 listed)
- 1. Patients with grafted bone (fibula, iliac, scapula) and receive postoperative implant surgery.
- 2.Clinical and radiogram data were available for all treatment periods and follow-up visits (Pre-/post-CBCT and panoramic radiographs).
- 3.Over twelve months follow-up period after implant placement. 4.Age > 18 years. 5.Fabrication and delivery of prosthesis following implant installation. 6.Treatment with a one-stage/two-stage surgical protocol.
Key exclusion criteria (3 listed)
- Patients diagnosed with osteoporosis.
- Lost or missing medical history during follow-up period.
- Follow-up period of dental implants was less than 12 months.
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 |
|---|---|---|
| dental implant placementThe time of dental implant surgery | Procedure or surgery | One stage dental implants placement, Second stage dental implants placement |
Primary outcome
The survival rate of the dental implants
Time frame: 12 months after surgery
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 21 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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 Prosthesis Failure, Dental and Dental Implant Failed, run by KU Leuven.
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 3 inclusion and 3 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 21 Nov 2022. 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?
The survival rate of the dental implants (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2022.