Complete DentureNCT03281603
Patient Satisfaction & Retention of Milled, 3D Printed and Conventional Complete Dentures
A study testing CAD/CAM complete denture in people with Complete Denture, run by Cairo University at 2 sites in Egypt.
Trial summary
The objective of this trial is to compare patient satisfaction and retention of complete denture manufactured by three different techniques: CAD/CAM milling, CAD/CAM 3D printing and conventional technique. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Complete Denture
- What is being tested?
- CAD/CAM complete denture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Oct 2017to 1 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completely edentulous patients ranging from age 55 to 75 years.
- Angle's Class I skeletal relationship.
- Well-developed ridge with U-shaped palatal vault and adequate firm mucosa.
- Last extraction took place six months ago.
- Normal facial symmetry.
- Cooperative patients.
Who cannot join
- -Temporomandibular disorders
- Uncontrolled diabetes
- Bleeding disorders or anticoagulant therapy
- Flabby tissues or sharp mandibular residual ridge.
- Heavy smokers.
- Patient's with neuromuscular disorders
Show all 9Show fewer
- Patients on chemotherapy or radiotherapy
- Severe psychiatric disorders
- Angle's class II and III skeletal relationship
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Dentistry,Cairo university
Giza, 002
Cairo university
Giza
About this study
Official title: A Study Comparing Patient Satisfaction and Retention of CAD /CAM Milled Complete Dentures and 3D Printed CAD/CAM Complete Dentures Versus Conventional Complete Dentures: A Randomized Clinical Trial
The objective of this trial is to compare patient satisfaction and retention of complete denture manufactured by three different techniques: CAD/CAM milling, CAD/CAM 3D printing and conventional technique.
Read the detailed description
Patient examination and diagnosis will be made at the outpatient clinic, department of prosthodontics, faculty of Dentistry-Cairo University. Eligible Patients following the inclusion criteria will be consented to enrol in the trial. Randomization and allocation concealment will be done through sealed envelopes having groups for interventions and comparator. Each patient enrolled in the trial will pick an envelope having either the intervention or control group.
Preliminary impressions will be made and poured to study casts. Customizing trays from autopolymerising acrylic resins for final impressions with Zinc Oxide Eugenol , then impressions will be poured into dental stone producing master casts. Record bite blocks will then be constructed and bite registration will be made.
All bite records with their corresponding master casts will be digitalized by an extraoral desktop 3D scanner having the station sequence of scanning upper cast, lower cast then bite registration to be stored as standard triangulation language (STL) files.
STL files are then imported to EXOCAD design software designing full dentures with their permanent bases, teeth sizes and shapes following the recorded inter-arch space. Full upper and lower designed denture bases will be stored as STL files ready for manufacturing.
In first Intervention: STL files will be imported to SHERA CNC CAM software ready for nesting each file for the suitable PMMA block size and height, ready for milling them in denture bases with SHERA 5-axis Eco-mill milling machine . After milling denture bases, acrylic teeth will be chosen for each patient with the suitable shade and size following the inter-arch space, then glued by auto-polymerizing resin in their corresponding sockets in the milled denture bases.
In second intervention: STL files will be imported to Mogassam 3D-printer CAM software followed by adjusting the object to be virtually placed on X,Y and Z axes on the printer plate to be ready for layering it in three dimension. Photopolymerizable PMMA liquid resin will be added in the printer and the files processed into 3D printed upper and lower denture bases. Acrylic teeth are then glued in their sockets in the printed denture bases using auto-polymerizable resin.
In control group:Conventional complete denture construction by normal processing steps will be made for patients enrolled in the control group.
For the three groups, full dentures will be delivered and checked for occlusion, speech and mastication. Patient satisfaction will be assessed by a questionnaire template for each patient to be recorded at the day of delivery (baseline), 3months then 6 months. Retention for dentures will be assessed by engaging the snap hook on denture bases and pulling action will be made with the digital force gauge device to obtain the records on the day of delivery (baseline), 3months then 6 months' follow-up interval.
- Conditions
- Complete Denture
- Being tested
- CAD/CAM complete denture
- Keywords
- Patient satisfaction, Retention
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM complete dentureDevice
complete denture will be designed by computer aided designing (CAD) and manufactured by computer aided manufacturing(CAM) utilizing Milling and 3D printing techniques
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM complete denture | Experimental | First intervention: Constructing complete denture by CAD/CAM technology utilizing milling technique.
Second intervention:Constructing complete denture CAD/CAM technology utilizing 3D printing technique Receives: Device: CAD/CAM complete denture |
| Conventional complete denture | Active comparator | Constructing complete denture by conventional technique of denture processing Receives: Device: CAD/CAM complete denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
The questionnaire will include 5 main categories; each category having questions about Functional complaint about the denture, Overall mastication ability, Masticating ability for different types of food, Effect of mental and daily life and Overall denture satisfaction.
Measured: 6 months
Secondary outcomes (1)
Retention
Digital Force gauge device applying a pulling action on a snap hook attached to geometric center of denture bases
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Oct 2017
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Complete DentureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mohamed Abo Heikal, Cairo University
- Investigators
- Mohamed M. Abo Heikal, PHD, Principal investigator, Assistant lecturer, faculty of Dentistry, MSA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281603
- Sponsor's protocol ID
- CEBD-CU-2017-08-24
- Status last verified
- Feb 2021
- First submitted
- 11 Sep 2017
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bidra 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 23763779Kanazawa M, Inokoshi M, Minakuchi S, Ohbayashi N. Trial of a CAD/CAM system for fabricating complete dentures. Dent Mater J. 2011;30(1):93-6. doi: 10.4012/dmj.2010-112. Epub 2011 Jan 26.
PubMed 21282882Maeda Y, Minoura M, Tsutsumi S, Okada M, Nokubi T. A CAD/CAM system for removable denture. Part I: Fabrication of complete dentures. Int J Prosthodont. 1994 Jan-Feb;7(1):17-21.
PubMed 8179777Han W, Li Y, Zhang Y, Lv Y, Zhang Y, Hu P, Liu H, Ma Z, Shen Y. Design and fabrication of complete dentures using CAD/CAM technology. Medicine (Baltimore). 2017 Jan;96(1):e5435. doi: 10.1097/MD.0000000000005435.
PubMed 28072686Infante 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 24461946Chen H, Wang H, Lv P, Wang Y, Sun Y. Quantitative Evaluation of Tissue Surface Adaption of CAD-Designed and 3D Printed Wax Pattern of Maxillary Complete Denture. Biomed Res Int. 2015;2015:453968. doi: 10.1155/2015/453968. Epub 2015 Oct 25.
PubMed 26583108Inokoshi M, Kanazawa M, Minakuchi S. Evaluation of a complete denture trial method applying rapid prototyping. Dent Mater J. 2012 Feb 3;31(1):40-6. doi: 10.4012/dmj.2011-113. Epub 2012 Jan 21.
PubMed 22277604Torabi K, Farjood E, Hamedani S. Rapid Prototyping Technologies and their Applications in Prosthodontics, a Review of Literature. J Dent (Shiraz). 2015 Mar;16(1):1-9.
PubMed 25759851AlHelal A, AlRumaih HS, Kattadiyil MT, Baba NZ, Goodacre CJ. Comparison of retention between maxillary milled and conventional denture bases: A clinical study. J Prosthet Dent. 2017 Feb;117(2):233-238. doi: 10.1016/j.prosdent.2016.08.007. Epub 2016 Oct 17.
PubMed 27765399Bilhan H, Erdogan O, Ergin S, Celik M, Ates G, Geckili O. Complication rates and patient satisfaction with removable dentures. J Adv Prosthodont. 2012 May;4(2):109-15. doi: 10.4047/jap.2012.4.2.109. Epub 2012 May 30.
PubMed 22737317
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing Patient Satisfaction and Retention of CAD /CAM Milled Complete Dentures and 3D Printed CAD/CAM Complete Dentures Versus Conventional Complete Dentures: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03281603
- Acronym / sponsor ID
- CEBD-CU-2017-08-24
- Conditions
- Complete Denture
- Keywords
- Patient satisfaction, Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 13 Sep 2017 (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.
The objective of this trial is to compare patient satisfaction and retention of complete denture manufactured by three different techniques: CAD/CAM milling, CAD/CAM 3D printing and conventional technique.
Detailed description
Patient examination and diagnosis will be made at the outpatient clinic, department of prosthodontics, faculty of Dentistry-Cairo University. Eligible Patients following the inclusion criteria will be consented to enrol in the trial. Randomization and allocation concealment will be done through sealed envelopes having groups for interventions and comparator. Each patient enrolled in the trial will pick an envelope having either the intervention or control group.
Preliminary impressions will be made and poured to study casts. Customizing trays from autopolymerising acrylic resins for final impressions with Zinc Oxide Eugenol , then impressions will be poured into dental stone producing master casts. Record bite blocks will then be constructed and bite registration will be made.
All bite records with their corresponding master casts will be digitalized by an extraoral desktop 3D scanner having the station sequence of scanning upper cast, lower cast then bite registration to be stored as standard triangulation language (STL) files.
STL files are then imported to EXOCAD design software designing full dentures with their permanent bases, teeth sizes and shapes following the recorded inter-arch space. Full upper and lower designed denture bases will be stored as STL files ready for manufacturing.
In first Intervention: STL files will be imported to SHERA CNC CAM software ready for nesting each file for the suitable PMMA block size and height, ready for milling them in denture bases with SHERA 5-axis Eco-mill milling machine . After milling denture bases, acrylic teeth will be chosen for each patient with the suitable shade and size following the inter-arch space, then glued by auto-polymerizing resin in their corresponding sockets in the milled denture bases.
In second intervention: STL files will be imported to Mogassam 3D-printer CAM software followed by adjusting the object to be virtually placed on X,Y and Z axes on the printer plate to be ready for layering it in three dimension. Photopolymerizable PMMA liquid resin will be added in the printer and the files processed into 3D printed upper and lower denture bases. Acrylic teeth are then glued in their sockets in the printed denture bases using auto-polymerizable resin.
In control group:Conventional complete denture construction by normal processing steps will be made for patients enrolled in the control group.
For the three groups, full dentures will be delivered and checked for occlusion, speech and mastication. Patient satisfaction will be assessed by a questionnaire template for each patient to be recorded at the day of delivery (baseline), 3months then 6 months. Retention for dentures will be assessed by engaging the snap hook on denture bases and pulling action will be made with the digital force gauge device to obtain the records on the day of delivery (baseline), 3months then 6 months' follow-up interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM complete denture | Experimental | Device: CAD/CAM complete dentureFirst intervention: Constructing complete denture by CAD/CAM technology utilizing milling technique. Second intervention:Constructing complete denture CAD/CAM technology utilizing 3D printing technique |
| Conventional complete denture | Active comparator | Device: CAD/CAM complete dentureConstructing complete denture by conventional technique of denture processing |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Completely edentulous patients ranging from age 55 to 75 years.
- Angle's Class I skeletal relationship.
- Well-developed ridge with U-shaped palatal vault and adequate firm mucosa.
- Last extraction took place six months ago.
- Normal facial symmetry.
Key exclusion criteria (9 listed)
- -Temporomandibular disorders
- Uncontrolled diabetes
- Bleeding disorders or anticoagulant therapy
- Flabby tissues or sharp mandibular residual ridge.
- Heavy smokers.
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 |
|---|---|---|
| CAD/CAM complete denturecomplete denture will be designed by computer aided designing (CAD) and manufactured by computer aided manufacturing(CAM) utilizing Milling and 3D printing techniques | Device | CAD/CAM complete denture, Conventional complete denture |
Primary outcome
patient satisfaction
Time frame: 6 months
The questionnaire will include 5 main categories; each category having questions about Functional complaint about the denture, Overall mastication ability, Masticating ability for different types of food, Effect of mental and daily life and Overall denture satisfaction.
1 secondary outcome
Retention
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- 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 21282882Kanazawa M, Inokoshi M, Minakuchi S, Ohbayashi N. Trial of a CAD/CAM system for fabricating complete dentures. Dent Mater J. 2011;30(1):93-6. doi: 10.4012/dmj.2010-112. Epub 2011 Jan 26.
- Background: PubMed 8179777Maeda Y, Minoura M, Tsutsumi S, Okada M, Nokubi T. A CAD/CAM system for removable denture. Part I: Fabrication of complete dentures. Int J Prosthodont. 1994 Jan-Feb;7(1):17-21.
- Background: PubMed 28072686Han W, Li Y, Zhang Y, Lv Y, Zhang Y, Hu P, Liu H, Ma Z, Shen Y. Design and fabrication of complete dentures using CAD/CAM technology. Medicine (Baltimore). 2017 Jan;96(1):e5435. doi: 10.1097/MD.0000000000005435.
- 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 26583108Chen H, Wang H, Lv P, Wang Y, Sun Y. Quantitative Evaluation of Tissue Surface Adaption of CAD-Designed and 3D Printed Wax Pattern of Maxillary Complete Denture. Biomed Res Int. 2015;2015:453968. doi: 10.1155/2015/453968. Epub 2015 Oct 25.
- Background: PubMed 22277604Inokoshi M, Kanazawa M, Minakuchi S. Evaluation of a complete denture trial method applying rapid prototyping. Dent Mater J. 2012 Feb 3;31(1):40-6. doi: 10.4012/dmj.2011-113. Epub 2012 Jan 21.
- Background: PubMed 25759851Torabi K, Farjood E, Hamedani S. Rapid Prototyping Technologies and their Applications in Prosthodontics, a Review of Literature. J Dent (Shiraz). 2015 Mar;16(1):1-9.
- Background: PubMed 27765399AlHelal A, AlRumaih HS, Kattadiyil MT, Baba NZ, Goodacre CJ. Comparison of retention between maxillary milled and conventional denture bases: A clinical study. J Prosthet Dent. 2017 Feb;117(2):233-238. doi: 10.1016/j.prosdent.2016.08.007. Epub 2016 Oct 17.
- Background: PubMed 22737317Bilhan H, Erdogan O, Ergin S, Celik M, Ates G, Geckili O. Complication rates and patient satisfaction with removable dentures. J Adv Prosthodont. 2012 May;4(2):109-15. doi: 10.4047/jap.2012.4.2.109. Epub 2012 May 30.
- 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.
Mohamed M. Abo Heikal, PHD principal investigator
Assistant lecturer, faculty of Dentistry, MSA University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD/CAM complete denture in people with Complete Denture, run by Cairo University at 2 sites in Egypt.
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 9 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: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
patient satisfaction (time frame: 6 months). 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 NCT03281603, which also lists 10 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 3 Feb 2021.