Patient Satisfaction & Retention of Milled, 3D Printed and Conventional Complete Dentures
NCT ID: NCT03281603
Last Updated: 2021-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
48 participants
INTERVENTIONAL
2017-10-01
2020-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Accuracy of 3D Printed Complete Dentures Using Two Impression Techniques: RCT
NCT04982510
Conventional Versus 3D Printing Duplication Techniques of Complete Denture
NCT06588140
Comparison of Patient Satisfaction and Chewing Efficiency Between Conventional and 3D Printed Complete Dentures.
NCT06103019
Patient Satisfaction and Adaptation of Dentures Printed at 0 Versus 45 Degrees
NCT06164366
Denture Retention of Intra-orally Scanned Versus Extra-orally Scanned Digitally Printed Maxillary Denture in Completely Edentulous Patients
NCT07290322
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CAD/CAM complete denture
First intervention: Constructing complete denture by CAD/CAM technology utilizing milling technique.
Second intervention:Constructing complete denture CAD/CAM technology utilizing 3D printing technique
CAD/CAM complete denture
complete denture will be designed by computer aided designing (CAD) and manufactured by computer aided manufacturing(CAM) utilizing Milling and 3D printing techniques
Conventional complete denture
Constructing complete denture by conventional technique of denture processing
CAD/CAM complete denture
complete denture will be designed by computer aided designing (CAD) and manufactured by computer aided manufacturing(CAM) utilizing Milling and 3D printing techniques
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CAD/CAM complete denture
complete denture will be designed by computer aided designing (CAD) and manufactured by computer aided manufacturing(CAM) utilizing Milling and 3D printing techniques
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* Uncontrolled diabetes
* Bleeding disorders or anticoagulant therapy
* Flabby tissues or sharp mandibular residual ridge.
* Heavy smokers.
* Patient's with neuromuscular disorders
* Patients on chemotherapy or radiotherapy
* Severe psychiatric disorders
* Angle's class II and III skeletal relationship
55 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohamed Mohamed Abo Heikal
Assistant lecturer, Department of Prosthodontics, Faculty of Dentistry, MSA University
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mohamed M. Abo Heikal, PHD
Role: PRINCIPAL_INVESTIGATOR
Assistant lecturer, faculty of Dentistry, MSA University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Dentistry,Cairo university
Giza, , Egypt
Cairo university
Giza, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Kanazawa 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.
Maeda 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.
Han 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.
Infante 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.
Chen 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.
Inokoshi 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.
Torabi 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.
AlHelal 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.
Bilhan 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CEBD-CU-2017-08-24
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.