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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06155630
• Other study ID #: 1680-2022
• Secondary ID: 1744-2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: November 2023
• Source: McGill University
• Contact: Raphael de Souza, DDS,MSc,PhD
• Phone: 5149137174
• Email: raphael.desouza[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion criteria:

• elderly according to the age cut-off purported by the World Health Organization (age >=60 years) and living independently;

• completely edentulous;

• no tooth extraction within the past 12 mo;

• two Straumann tissue level RN implants symmetrically distributed in the anterior mandible for 3 or + mo before the trial interventions;

• desire to receive both upper denture and lower IMO with new stud attachments;

• good understanding of spoken and written English or French;

• Ability to provide written informed consent.

Exclusion criteria:

• severe systemic disease or needing frequent hospitalization (i.e. American Society of Anesthesiologists Physical Status class >II);

• evidence of cognitive or motor impairment;

• acute or chronic symptoms of parafunctional or temporomandibular disorders;

• intraoral pathologies, either acute, progressive, potentially malignant or capable to hamper denture fit;

• signs of endosseous lesions or residual dental structures in panoramic radiographs;

• signs of implant failure, including clinical mobility, peri-implant radiolucency, unacceptable bone loss (0.2mm/year after 1st year, or <2mm any time) and persistent signs/symptoms (pain, neuropathy, infection or exudate).

Related Conditions & MeSH terms

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

Intervention

Other:
• mandibular implant-overdenture
Mandibular overdentures fabricated over two implants will be delivered to the patients. In the first group, the 3D printed overdentures will be given for 3 months, followed by 3-month wear of traditional overdentures. The second group will wear traditional overdenture first followed by 3 months of 3D printed overdenture.

Locations

Country	Name	City	State
Canada	McGill University, Faculty of Dentistry	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	ITI International Team for Implantology, Switzerland

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient general satisfaction with full dentures	The investigators will use the McGill Denture Satisfaction Questionnaire (MDSQ) to measure overall satisfaction (primary outcome), and satisfaction with specific aspects of the dentures - ability to chew, comfort, stability, aesthetics, ability to speak, and ability to clean	Baseline and after 3 months of wearing each denture
Secondary	Oral health related quality of life (OHQoL)	This will be assessed by the OHIP-EDENT questionnaire	Baseline and after 3 months of wearing each denture
Secondary	Clinical denture quality	This trial will use the Functional Assessment of Dentures (FAD) instrument to assess denture quality from clinicians' perspective	Baseline and after 3 months of wearing each denture
Secondary	Cost	The investigators will gather data on both the direct and indirect costs of each denture fabrication method	through study completion, an average of 1 year
Secondary	Qualitative report of adverse effects and maintenance needs. e.g. broken or stained dentures	The investigators will record all adverse events during the RCT at each post-delivery appointment and follow-up.	through study completion, an average of 1 year