Edentulous MouthNCT06155630
3D Printing for the Fabrication of Mandibular Implant Overdentures
A study testing mandibular implant-overdenture in people with Edentulous Mouth and Edentulous Jaw, run by McGill University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Mouth, Edentulous Jaw
- What is being tested?
- mandibular implant-overdenture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2023to 1 Sep 2025
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University, Faculty of Dentistry
Montreal, Quebec, H3A1G1
Raphel F de Souza, +1(514)913-7174, raphael.desouza@mcgill.ca
de Souza
About this study
Official title: 3D Printing vs Traditional Workflow for the Fabrication of Mandibular Implant Overdentures: A Randomized Cross-over Clinical Trial
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.
Read more
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.
- Conditions
- Edentulous Mouth, Edentulous Jaw
- Being tested
- mandibular implant-overdenture
- Keywords
- 3D printing, Implant overdenture, clinical trial
- Medical subject headings
- Mouth, Edentulous, Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mandibular implant-overdentureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 3D printed mandibular implant overdenture | Experimental | First appointment: The first visit will consist of scanning the patients' existing upper complete denture and lower mandibular implant overdenture by using a desktop scanner. In the lab, the .stl files will be 3D printed using a DLP 3D printer. Second clinical appointment: the interim printed dentures will be adjusted with wax for the desired lip support and VD. Secondary impressions will be taken to refine fit. Maxillary and mandibular interim printed dentures will be scanned separately and together with an intraoral scanner. Patient's face will also be scanned by a face scanner. 2nd lab session: .stl files will be superimposed for the digital pathway. Teeth and denture bases will be designed virtually. Dentures bases will be manufactured by a DLP 3D printer with Dentca Resin. Dentures will receive Dentsply Portrait 3D teeth. Dentures will be finished and polished, and sandblasted in the attachment sockets. 4th appointment: denture delivery. Receives: Other: mandibular implant-overdenture |
| traditional mandibular implant overdenture | Active comparator | The first visit will be the same. For the conventional pathway, the 2nd lab session will consist of pouring the impressions (type 4 stone), mounting the casts in arcon semi-adjustable articulator, removing the printed teeth, and replacing it with wax rim and acrylic tooth setup (Dentsply Portrait - same shape, size and shade used for 3D printed dentures).
A 3rd appointment will be used for wax try-in for the conventional pathway. For the digital pathway, participants will have a chance to appraise their smile on a computer screen (virtual try-in, done remotely) and request modifications.
Denture bases will be manufactured with conventional heat-polymerized resins, and participants will return for a 4th appointment for delivery, including chairside pick-up of attachments (GC Reline resin). Two short-term adjustments will be scheduled 24-72 h and 7 days after delivery, and then weekly until the dentures are comfortable. Receives: Other: mandibular implant-overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and after 3 months of wearing each denture
Secondary outcomes (4)
Oral health related quality of life (OHQoL)
This will be assessed by the OHIP-EDENT questionnaire
Measured: Baseline and after 3 months of wearing each denture
Clinical denture quality
This trial will use the Functional Assessment of Dentures (FAD) instrument to assess denture quality from clinicians' perspective
Measured: Baseline and after 3 months of wearing each denture
Cost
The investigators will gather data on both the direct and indirect costs of each denture fabrication method
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start30 Nov 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Edentulous MouthStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155630
- Sponsor's protocol ID
- 1680-2022
- Other IDs
- 1744-2023
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IDP will be shared according to the regulations set by McGill University, by the McGill Dataverse collection (available at: https://www.mcgill.ca/library/services/data-services/sharing )
Publications
Jafarpour D, El-Amier N, Feine J, Bedos C, Abi-Nader S, Esfandiari S, Shuster T, Zimmermann E, de Souza R. 3D printing vs traditional workflow for the fabrication of mandibular implant overdentures: study protocol for a mixed-methods cross-over RCT. Trials. 2024 Apr 16;25(1):267. doi: 10.1186/s13063-024-08097-7.
PubMed 38627819
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printing vs Traditional Workflow for the Fabrication of Mandibular Implant Overdentures: A Randomized Cross-over Clinical Trial
- ClinicalTrials.gov ID
- NCT06155630
- Acronym / sponsor ID
- 1680-2022
- Conditions
- Edentulous Mouth, Edentulous Jaw
- Keywords
- 3D printing, Implant overdenture, clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Study start
- 30 Nov 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 4 Dec 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D printed mandibular implant overdenture | Experimental | Other: mandibular implant-overdentureFirst appointment: The first visit will consist of scanning the patients' existing upper complete denture and lower mandibular implant overdenture by using a desktop scanner. In the lab, the .stl files will be 3D printed using a DLP 3D printer. Second clinical appointment: the interim printed dentures will be adjusted with wax for the desired lip support and VD. Secondary impressions will be taken to refine fit. Maxillary and mandibular interim printed dentures will be scanned separately and together with an intraoral scanner. Patient's face will also be scanned by a face scanner. 2nd lab session: .stl files will be superimposed for the digital pathway. Teeth and denture bases will be designed virtually. Dentures bases will be manufactured by a DLP 3D printer with Dentca Resin. Dentures will receive Dentsply Portrait 3D teeth. Dentures will be finished and polished, and sandblasted in the attachment sockets. 4th appointment: denture delivery. |
| traditional mandibular implant overdenture | Active comparator | Other: mandibular implant-overdentureThe first visit will be the same. For the conventional pathway, the 2nd lab session will consist of pouring the impressions (type 4 stone), mounting the casts in arcon semi-adjustable articulator, removing the printed teeth, and replacing it with wax rim and acrylic tooth setup (Dentsply Portrait - same shape, size and shade used for 3D printed dentures). A 3rd appointment will be used for wax try-in for the conventional pathway. For the digital pathway, participants will have a chance to appraise their smile on a computer screen (virtual try-in, done remotely) and request modifications. Denture bases will be manufactured with conventional heat-polymerized resins, and participants will return for a 4th appointment for delivery, including chairside pick-up of attachments (GC Reline resin). Two short-term adjustments will be scheduled 24-72 h and 7 days after delivery, and then weekly until the dentures are comfortable. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| mandibular implant-overdentureMandibular 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. | Other | 3D printed mandibular implant overdenture, traditional mandibular implant overdenture |
Primary outcome
Patient general satisfaction with full dentures
Time frame: Baseline and after 3 months of wearing each denture
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
4 secondary outcomes
Oral health related quality of life (OHQoL)
Time frame: Baseline and after 3 months of wearing each denture
Clinical denture quality
Time frame: Baseline and after 3 months of wearing each denture
Cost
Time frame: through study completion, an average of 1 year
Qualitative report of adverse effects and maintenance needs. e.g. broken or stained dentures
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Derived from this study: PubMed 38627819Jafarpour D, El-Amier N, Feine J, Bedos C, Abi-Nader S, Esfandiari S, Shuster T, Zimmermann E, de Souza R. 3D printing vs traditional workflow for the fabrication of mandibular implant overdentures: study protocol for a mixed-methods cross-over RCT. Trials. 2024 Apr 16;25(1):267. doi: 10.1186/s13063-024-08097-7.
- Individual participant dataSharing planned: Yes. IDP will be shared according to the regulations set by McGill University, by the McGill Dataverse collection (available at: https://www.mcgill.ca/library/services/data-services/sharing )
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mandibular implant-overdenture in people with Edentulous Mouth and Edentulous Jaw, run by McGill University at 1 site in Canada.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raphael de Souza, DDS,MSc,PhD (5149137174, raphael.desouza@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient general satisfaction with full dentures (time frame: Baseline and after 3 months of wearing each denture). 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 NCT06155630, which also lists 1 linked publication.
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 4 Dec 2023.