Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06155630
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-04
First Post:
2023-11-22
Brief Title:
3D Printing for the Fabrication of Mandibular Implant Overdentures
Sponsor:
McGill University
Organization:
McGill University
Study Overview
Official Title:
3D Printing vs Traditional Workflow for the Fabrication of Mandibular Implant Overdentures A Randomized Cross-over Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
CADCAM computer-aided design and computer-aided manufacturing can be a game-changer for better access to care by edentulous patients Digital overdentures offer potential for more satisfied patients due to better fit and can be provided fasterwith lower costs Providing digital overdentures has potential to enhance access to oral healthcare by the elderly given the expected benefits better quality simpler faster and more affordable than those obtained traditionally However evidence from randomized trials is crucial to verify the relevance of those benefits especially from the patient perspective and to confirm those benefits This trial also serves as an opportunity to improve CAD software and materials since it will identify technical challenges specific to the provision of digital overdentures
This randomized cross-over trial aims to reveal whether implant-retained mandibular overdentures IMO produced by CAD and 3D printing are more satisfactory to edentulous seniors than those fabricated using traditional methods
The investigators will recruit 26 edentulous participants any sexgender amongst previous patients at McGill University based on the following eligibility criteria complete edentulism elderly age 60 years according to the WHO need for new maxillary and mandibular complete dentures ability to complete questionnaires and previous treatment with two implants in the anterior mandible Each participant will receive two pairs of dentures as per the McGill Consensus on Implant Overdentures ie a mandibular overdenture opposed by a maxillary complete denture i one by digital rendering of the mouth virtual prosthetic design and 3D printing ii a control pair by traditional clinical and laboratory methods Each pair will be worn for 3 months according to a random sequence total follow-up 6 months after the delivery of the first pair of dentures Both overdentures will be retained by 2 Novaloc abutments and medium retention matrices
Outcomes will include patient satisfaction ratings and oral health-related quality of life The investigators will evaluate other patient-reported outcomes as well as clinician-assessed quality and cost Outcome assessment will occur at baseline then at three months after participants have worn each pair of dentures Following the cross-over participants will keep their preferred denture pair and return after 12 months to evaluate maintenance requirements including stained and broken dentures
This randomized cross-over trial aims to reveal whether implant-retained mandibular overdentures IMO produced by CAD and 3D printing are more satisfactory to edentulous seniors than those fabricated using traditional methods
The investigators will recruit 26 edentulous participants any sexgender amongst previous patients at McGill University based on the following eligibility criteria complete edentulism elderly age 60 years according to the WHO need for new maxillary and mandibular complete dentures ability to complete questionnaires and previous treatment with two implants in the anterior mandible Each participant will receive two pairs of dentures as per the McGill Consensus on Implant Overdentures ie a mandibular overdenture opposed by a maxillary complete denture i one by digital rendering of the mouth virtual prosthetic design and 3D printing ii a control pair by traditional clinical and laboratory methods Each pair will be worn for 3 months according to a random sequence total follow-up 6 months after the delivery of the first pair of dentures Both overdentures will be retained by 2 Novaloc abutments and medium retention matrices
Outcomes will include patient satisfaction ratings and oral health-related quality of life The investigators will evaluate other patient-reported outcomes as well as clinician-assessed quality and cost Outcome assessment will occur at baseline then at three months after participants have worn each pair of dentures Following the cross-over participants will keep their preferred denture pair and return after 12 months to evaluate maintenance requirements including stained and broken dentures
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1744-2023 | OTHER_GRANT | ITI | None |