Mouth, EdentulousNCT02521935
Conventionally vs. Digitally Fabricated Complete Dentures: Clinical Treatment Outcome Differences
A study testing Complete traditional dentures and Complete CADCAM dentures in people with Mouth, Edentulous, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: To compare complete denture outcomes between conventional and digital denture fabrication processes. Participants: Sixteen edentulous adult patients in the University of North Carolina School of Dentistry Student Clinic who are seeking removable complete dentures. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Mouth, Edentulous
- What is being tested?
- Complete traditional dentures and Complete CADCAM dentures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jan 2020
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- UNC School of Dentistry Student Clinic patients requiring maxillary and mandibular complete dentures
- Ages 18 to 99, inclusive
- Able to read, speak, and understand English
- Without natural tooth or implant supported overdentures
- Edentulous in both jaws for at least 6 months
- Any Prosthodontic Diagnostic Index (PDI) type with a preference given to Types 1-3
Who cannot join
- Non-registered patient in UNC School of Dentistry student clinics
- Patient not able or unwilling to give consent
- Subject had extractions within last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina School of Dentistry Student Clinics
Chapel Hill, North Carolina, 27599
About this study
Purpose: To compare complete denture outcomes between conventional and digital denture fabrication processes.
Participants: Sixteen edentulous adult patients in the University of North Carolina School of Dentistry Student Clinic who are seeking removable complete dentures.
Procedures (methods): Two complete sets of dentures will be fabricated for each subject: one using the conventional process (A) and the other using a digital process (B). Variability will be assessed by the research team, the treating dental students, an independent prosthodontist, and the patients through quantitative measures. Case selection and results analysis will be evaluated with recognition of the Prosthodontic Diagnostic Index.
Read the detailed description
Rationale for Study Design An AB/BA (conventional=A, digital=B) crossover design with no wash-out period is flawed for this study, and its weakness is the potential for a carryover effect (benefits or risks associated with treatment A carry over to treatment B). A wash-out period is not feasible for this study because it would require the patient-subjects to suspend use of their dentures for the duration of the wash-out period.
The Investigators have decided to conduct the study using the ABB/BAA crossover design, which does not require a wash-out period and will permit testing and discounting of a possible carryover effect. In addition, this design is more appropriate for a small sample size than the AB/BA design.
The investigators are adding to the scant literature on digital dentures, information that has never before been studied - the retention, aesthetics, and stability of digital dentures compared to conventional dentures. Additionally, the investigators will have longitudinal data on these characteristics regarding digital dentures.
If the Functional Assessment of Dentures (FAD) and the patient evaluation show positive results for the digital dentures, this could lead to increased use of the Computer -Aided Design/ Computer -Aided Manufacturing (CADCAM) fabrication method which, in turn, would allow greater numbers of people to benefit from the advantages of the digital dentures as described earlier in this application (e.g., a better fit, fewer visits with less time in the chair, less biofilm formation, etc.)
- Conditions
- Mouth, Edentulous
- Being tested
- Complete traditional dentures, Complete CADCAM dentures
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete traditional denturesDevice
Also called complete conventional dentures
Arm 1-Standard Treatment Sequence for Traditional Removable Dentures in a Dental School Clinic (9 Appointments):
Appointment 1: Examination \& diagnosis \& initial impressions.
Appointment 2: Secondary impressions.
Appointment 3: Secondary or definitive impressions (Often 2 appointments are needed to border mold and impression)
Appointment 4: Maxillo-mandibular jaw relation records (both centric and vertical relation). Tooth selection.
Appointment 5: Wax-trial denture try-in.
Appointment 6: Insertion and instructions for care of definitive prostheses.
Appointments 7-9 Post adjustments
Complete CADCAM denturesDevice
Also called complete digital dentures
Arm 2-Standard Treatment Sequence for Digital Dentures in a Dental School Clinic (5 appointments):
Appointment 1: Exam, diagnosis, \& tray selection (begin impressions)
Appointment 2: Definitive impressions and Maxillomandibula relations
Appointment 3: Wax-trial arrangement
Appointment 4: Insertion and instructions for care of definitive prosthesis
Appointment 5: Post adjustment/s (Less post insertion adjustments are anticipated due to CADCAM milling of the denture base and less polymerization shrinkage
| Study group | Role | What they receive |
|---|---|---|
| Complete traditional dentures | Active comparator | Complete maxillary/mandible dentures made in the traditional manner. Receives: Device: Complete traditional dentures |
| Complete CADCAM dentures | Active comparator | Complete maxillary/mandible dentures made with CADCAM (computer-aided design/computer-aided manufacturing) technology Receives: Device: Complete CADCAM dentures |
What is being measured
The primary outcome is the main question the study is designed to answer.
the overall comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures
evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD= Functional Assessment of Dentures)
Measured: 2 years
Secondary outcomes (14)
comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures
evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD= Functional Assessment of Dentures)
Measured: baseline = 4 weeks
comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures
evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD)
Measured: 3 months
comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures
evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD)
Measured: 6 months
comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures
evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD)
Measured: 1 year
comparison of patient satisfaction between digital dentures and traditional dentures
patient satisfaction survey consisting of 12 items organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and responses are based on a Likert scale
Measured: baseline = 4 weeks
comparison of patient satisfaction between digital dentures and traditional dentures
patient satisfaction survey consisting of 12 items organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and responses are based on a Likert scale
Measured: 3 months
comparison of patient satisfaction between digital dentures and traditional dentures
patient satisfaction survey consisting of 12 items organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and responses are based on a Likert scale
Measured: 6 months
comparison of patient satisfaction between digital dentures and traditional dentures
patient satisfaction survey consisting of 12 items organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and responses are based on a Likert scale
Measured: 1 year
comparison of patient satisfaction between digital dentures and traditional dentures
patient satisfaction survey consisting of 12 items organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and responses are based on a Likert scale
Measured: 2 year
bite force comparison between digital dentures and traditional dentures
using gnathometer assessment, investigators will record the force (on a 0-10 scale) during dislodgement
Measured: baseline = 4 weeks
bite force comparison between digital dentures and traditional dentures
using gnathometer assessment, investigators will record the force (on a 0-10 scale) during dislodgement
Measured: 3 months
bite force comparison between digital dentures and traditional dentures
using gnathometer assessment, investigators will record the force (on a 0-10 scale) during dislodgement
Measured: 6 months
bite force comparison between digital dentures and traditional dentures
using gnathometer assessment, investigators will record the force (on a 0-10 scale) during dislodgement
Measured: 1 year
bite force comparison between digital dentures and traditional dentures
using gnathometer assessment, investigators will record the force (on a 0-10 scale) during dislodgement
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: The PI is deceased, decision was made to withdraw.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Mouth, EdentulousStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Global Dental Science, LLC
- Responsible party
- Sponsor
- Investigators
- Robert F Wright, DDS FACP, Principal investigator, Professor and Chair, Dept. of Prosthodontics UNC School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521935
- Sponsor's protocol ID
- 14-1811
- Status last verified
- Apr 2017
- First submitted
- 16 Jul 2015
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
McCord JF. Contemporary techniques for denture fabrication. J Prosthodont. 2009 Feb;18(2):106-11. doi: 10.1111/j.1532-849X.2009.00439.x.
PubMed 19254299Goodacre CJ, Garbacea A, Naylor WP, Daher T, Marchack CB, Lowry J. CAD/CAM fabricated complete dentures: concepts and clinical methods of obtaining required morphological data. J Prosthet Dent. 2012 Jan;107(1):34-46. doi: 10.1016/S0022-3913(12)60015-8.
PubMed 22230914Lee WS, Kim WC, Kim HY, Kim WT, Kim JH. Evaluation of different approaches for using a laser scanner in digitization of dental impressions. J Adv Prosthodont. 2014 Feb;6(1):22-9. doi: 10.4047/jap.2014.6.1.22. Epub 2014 Feb 14.
PubMed 24605202Kattadiyil MT, Goodacre CJ, Baba NZ. CAD/CAM complete dentures: a review of two commercial fabrication systems. J Calif Dent Assoc. 2013 Jun;41(6):407-16.
PubMed 23875432Bidra AS, Taylor TD, Agar JR. Computer-aided technology for fabricating complete dentures: systematic review of historical background, current status, and future perspectives. J Prosthet Dent. 2013 Jun;109(6):361-6. doi: 10.1016/S0022-3913(13)60318-2.
PubMed 23763779Darvell BW, Clark RK. The physical mechanisms of complete denture retention. Br Dent J. 2000 Sep 9;189(5):248-52. doi: 10.1038/sj.bdj.4800734.
PubMed 11048392Parvizi A, Lindquist T, Schneider R, Williamson D, Boyer D, Dawson DV. Comparison of the dimensional accuracy of injection-molded denture base materials to that of conventional pressure-pack acrylic resin. J Prosthodont. 2004 Jun;13(2):83-9. doi: 10.1111/j.1532-849X.2004.04014.x.
PubMed 15210003Infante L, Yilmaz B, McGlumphy E, Finger I. Fabricating complete dentures with CAD/CAM technology. J Prosthet Dent. 2014 May;111(5):351-5. doi: 10.1016/j.prosdent.2013.10.014. Epub 2014 Jan 23.
PubMed 24461946Alfadda SA. The relationship between various parameters of complete denture quality and patients' satisfaction. J Am Dent Assoc. 2014 Sep;145(9):941-8. doi: 10.14219/jada.2013.48.
PubMed 25170001Allen PF, McMillan AS, Walshaw D. A patient-based assessment of implant-stabilized and conventional complete dentures. J Prosthet Dent. 2001 Feb;85(2):141-7. doi: 10.1067/mpr.2001.113214.
PubMed 11208203Anastassiadou V, Naka O, Heath MR, Kapari D. Validation of indices for functional assessment of dentures. Gerodontology. 2002 Jul;19(1):46-52. doi: 10.1111/j.1741-2358.2002.00046.x.
PubMed 12164239Corrigan PJ, Basker RM, Farrin AJ, Mulley GP, Heath MR. The development of a method for functional assessment of dentures. Gerodontology. 2002 Jul;19(1):41-5. doi: 10.1111/j.1741-2358.2002.00041.x.
PubMed 12164238Fenlon MR, Sherriff M, Walter JD. An investigation of factors influencing patients' use of new complete dentures using structural equation modelling techniques. Community Dent Oral Epidemiol. 2000 Apr;28(2):133-40. doi: 10.1034/j.1600-0528.2000.028002133.x.
PubMed 10730722Sato Y, Hamada S, Akagawa Y, Tsuga K. A method for quantifying overall satisfaction of complete denture patients. J Oral Rehabil. 2000 Nov;27(11):952-7. doi: 10.1046/j.1365-2842.2000.00579.x.
PubMed 11106986Sato Y, Tsuga K, Akagawa Y, Tenma H. A method for quantifying complete denture quality. J Prosthet Dent. 1998 Jul;80(1):52-7. doi: 10.1016/s0022-3913(98)70091-5.
PubMed 9656178
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventionally vs. Digitally Fabricated Complete Dentures: Clinical Treatment Outcome Differences
- ClinicalTrials.gov ID
- NCT02521935
- Acronym / sponsor ID
- 14-1811
- Conditions
- Mouth, Edentulous
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI is deceased, decision was made to withdraw.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Global Dental Science, LLC
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 13 Aug 2015 (estimated)
- 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.
Purpose: To compare complete denture outcomes between conventional and digital denture fabrication processes.
Participants: Sixteen edentulous adult patients in the University of North Carolina School of Dentistry Student Clinic who are seeking removable complete dentures.
Procedures (methods): Two complete sets of dentures will be fabricated for each subject: one using the conventional process (A) and the other using a digital process (B). Variability will be assessed by the research team, the treating dental students, an independent prosthodontist, and the patients through quantitative measures. Case selection and results analysis will be evaluated with recognition of the Prosthodontic Diagnostic Index.
Detailed description
Rationale for Study Design An AB/BA (conventional=A, digital=B) crossover design with no wash-out period is flawed for this study, and its weakness is the potential for a carryover effect (benefits or risks associated with treatment A carry over to treatment B). A wash-out period is not feasible for this study because it would require the patient-subjects to suspend use of their dentures for the duration of the wash-out period.
The Investigators have decided to conduct the study using the ABB/BAA crossover design, which does not require a wash-out period and will permit testing and discounting of a possible carryover effect. In addition, this design is more appropriate for a small sample size than the AB/BA design.
The investigators are adding to the scant literature on digital dentures, information that has never before been studied - the retention, aesthetics, and stability of digital dentures compared to conventional dentures. Additionally, the investigators will have longitudinal data on these characteristics regarding digital dentures.
If the Functional Assessment of Dentures (FAD) and the patient evaluation show positive results for the digital dentures, this could lead to increased use of the Computer -Aided Design/ Computer -Aided Manufacturing (CADCAM) fabrication method which, in turn, would allow greater numbers of people to benefit from the advantages of the digital dentures as described earlier in this application (e.g., a better fit, fewer visits with less time in the chair, less biofilm formation, etc.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complete traditional dentures | Active comparator | Device: Complete traditional denturesComplete maxillary/mandible dentures made in the traditional manner. |
| Complete CADCAM dentures | Active comparator | Device: Complete CADCAM denturesComplete maxillary/mandible dentures made with CADCAM (computer-aided design/computer-aided manufacturing) technology |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- UNC School of Dentistry Student Clinic patients requiring maxillary and mandibular complete dentures
- Ages 18 to 99, inclusive
- Able to read, speak, and understand English
- Without natural tooth or implant supported overdentures
- Edentulous in both jaws for at least 6 months
Key exclusion criteria (3 listed)
- Non-registered patient in UNC School of Dentistry student clinics
- Patient not able or unwilling to give consent
- Subject had extractions within last 6 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 |
|---|---|---|
| Complete traditional denturesAlso: complete conventional denturesArm 1-Standard Treatment Sequence for Traditional Removable Dentures in a Dental School Clinic (9 Appointments): Appointment 1: Examination \& diagnosis \& initial impressions. Appointment 2: Secondary impressions. Appointment 3: Secondary or definitive impressions (Often 2 appointments are needed to border mold and impression) Appointment 4: Maxillo-mandibular jaw relation records (both centric and vertical relation). Tooth selection. Appointment 5: Wax-trial denture try-in. Appointment 6: Insertion and instructions for care of definitive prostheses. Appointments 7-9 Post adjustments | Device | Complete traditional dentures |
| Complete CADCAM denturesAlso: complete digital denturesArm 2-Standard Treatment Sequence for Digital Dentures in a Dental School Clinic (5 appointments): Appointment 1: Exam, diagnosis, \& tray selection (begin impressions) Appointment 2: Definitive impressions and Maxillomandibula relations Appointment 3: Wax-trial arrangement Appointment 4: Insertion and instructions for care of definitive prosthesis Appointment 5: Post adjustment/s (Less post insertion adjustments are anticipated due to CADCAM milling of the denture base and less polymerization shrinkage | Device | Complete CADCAM dentures |
Primary outcome
the overall comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures
Time frame: 2 years
evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD= Functional Assessment of Dentures)
14 secondary outcomes
comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures
Time frame: baseline = 4 weeks
comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures
Time frame: 3 months
comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures
Time frame: 6 months
comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures
Time frame: 1 year
comparison of patient satisfaction between digital dentures and traditional dentures
Time frame: baseline = 4 weeks
comparison of patient satisfaction between digital dentures and traditional dentures
Time frame: 3 months
comparison of patient satisfaction between digital dentures and traditional dentures
Time frame: 6 months
comparison of patient satisfaction between digital dentures and traditional dentures
Time frame: 1 year
comparison of patient satisfaction between digital dentures and traditional dentures
Time frame: 2 year
bite force comparison between digital dentures and traditional dentures
Time frame: baseline = 4 weeks
bite force comparison between digital dentures and traditional dentures
Time frame: 3 months
bite force comparison between digital dentures and traditional dentures
Time frame: 6 months
bite force comparison between digital dentures and traditional dentures
Time frame: 1 year
bite force comparison between digital dentures and traditional dentures
Time frame: 2 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Background: PubMed 19254299McCord JF. Contemporary techniques for denture fabrication. J Prosthodont. 2009 Feb;18(2):106-11. doi: 10.1111/j.1532-849X.2009.00439.x.
- Background: PubMed 22230914Goodacre CJ, Garbacea A, Naylor WP, Daher T, Marchack CB, Lowry J. CAD/CAM fabricated complete dentures: concepts and clinical methods of obtaining required morphological data. J Prosthet Dent. 2012 Jan;107(1):34-46. doi: 10.1016/S0022-3913(12)60015-8.
- Background: PubMed 24605202Lee WS, Kim WC, Kim HY, Kim WT, Kim JH. Evaluation of different approaches for using a laser scanner in digitization of dental impressions. J Adv Prosthodont. 2014 Feb;6(1):22-9. doi: 10.4047/jap.2014.6.1.22. Epub 2014 Feb 14.
- Background: PubMed 23875432Kattadiyil MT, Goodacre CJ, Baba NZ. CAD/CAM complete dentures: a review of two commercial fabrication systems. J Calif Dent Assoc. 2013 Jun;41(6):407-16.
- Background: PubMed 23763779Bidra AS, Taylor TD, Agar JR. Computer-aided technology for fabricating complete dentures: systematic review of historical background, current status, and future perspectives. J Prosthet Dent. 2013 Jun;109(6):361-6. doi: 10.1016/S0022-3913(13)60318-2.
- Background: PubMed 11048392Darvell BW, Clark RK. The physical mechanisms of complete denture retention. Br Dent J. 2000 Sep 9;189(5):248-52. doi: 10.1038/sj.bdj.4800734.
- Background: PubMed 15210003Parvizi A, Lindquist T, Schneider R, Williamson D, Boyer D, Dawson DV. Comparison of the dimensional accuracy of injection-molded denture base materials to that of conventional pressure-pack acrylic resin. J Prosthodont. 2004 Jun;13(2):83-9. doi: 10.1111/j.1532-849X.2004.04014.x.
- Background: PubMed 24461946Infante L, Yilmaz B, McGlumphy E, Finger I. Fabricating complete dentures with CAD/CAM technology. J Prosthet Dent. 2014 May;111(5):351-5. doi: 10.1016/j.prosdent.2013.10.014. Epub 2014 Jan 23.
- Background: PubMed 25170001Alfadda SA. The relationship between various parameters of complete denture quality and patients' satisfaction. J Am Dent Assoc. 2014 Sep;145(9):941-8. doi: 10.14219/jada.2013.48.
- Background: PubMed 11208203Allen PF, McMillan AS, Walshaw D. A patient-based assessment of implant-stabilized and conventional complete dentures. J Prosthet Dent. 2001 Feb;85(2):141-7. doi: 10.1067/mpr.2001.113214.
- Background: PubMed 12164239Anastassiadou V, Naka O, Heath MR, Kapari D. Validation of indices for functional assessment of dentures. Gerodontology. 2002 Jul;19(1):46-52. doi: 10.1111/j.1741-2358.2002.00046.x.
- Background: PubMed 12164238Corrigan PJ, Basker RM, Farrin AJ, Mulley GP, Heath MR. The development of a method for functional assessment of dentures. Gerodontology. 2002 Jul;19(1):41-5. doi: 10.1111/j.1741-2358.2002.00041.x.
- Individual participant dataSharing planned: No
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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.
Robert F Wright, DDS FACP principal investigator
Professor and Chair, Dept. of Prosthodontics UNC School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete traditional dentures and Complete CADCAM dentures in people with Mouth, Edentulous, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 6 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: withdrawn, as of the sponsor's last update on 27 Apr 2017. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 overall comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures (time frame: 2 years). 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 NCT02521935, which also lists 16 linked publications.
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 27 Apr 2017.