3D Printing for the Fabrication of Mandibular Implant Overdentures

Edentulous Jaw Clinical Trial

Official title: 3D Printing vs Traditional Workflow for the Fabrication of Mandibular Implant Overdentures: A Randomized Cross-over Clinical Trial

Status Not yet recruiting

Clinical Trial Summary

CAD/CAM (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 faster/with 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 sex/gender) 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 (i.e., 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Edentulous Jaw
• Edentulous Mouth
• Jaw, Edentulous
• Mouth, Edentulous

• NCT number: NCT06155630
• Study type: Interventional
• Source: McGill University
• Contact: Raphael de Souza, DDS,MSc,PhD
• Phone: 5149137174
• Email: raphael.desouza@mcgill.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2023
• Completion date: September 1, 2025