ClinicalTrials.gg
CompletedNCT03281603Updated Feb 3, 2021

Patient Satisfaction & Retention of Milled, 3D Printed and Conventional Complete Dentures

An interventional study of CAD/CAM complete denture in Complete Denture, sponsored by Cairo University. Completed at 2 sites in Egypt. Open to participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-03.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
55 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 34 studies in Patient Satisfaction by Cairo University — 2 open to participants now, 2 under way, none of them phase 3. Patient Satisfaction · Cairo University.

Enrollment
7th of 32
48 · median 25
Started
2017
with 5 others
No phase
29 of 34
2 open now
Registered
6th of 34
by date

Among the 34 studies in Patient Satisfaction by Cairo University, this one is the 7th largest by enrollment of the 32 interventional ones that give a count, is one of 6 that started in 2017, is one of 29 with no phase, and was the 6th registered.

Patient Satisfaction

877 studies on the registry are indexed under Patient Satisfaction; 202 are open to participants now.

Browse Patient Satisfaction studies →

Open to participants now

2 of the 34 studies in Patient Satisfaction by Cairo University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 99 Patient Satisfaction studies recruiting now, 61 (62%) set no upper age limit and 30 (30%) stop at 75 or younger; 14 take children under 18; 26 take healthy volunteers.

This study: 55 Years to 75 Years · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 34 studies in Patient Satisfaction by Cairo University, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Complete Denture

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Keywords

  • Patient satisfaction
  • Retention
04

Who can participate

Ages eligible
55 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • -Temporomandibular disorders
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    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

    Device: CAD/CAM complete denture

  • Active comparator
    Conventional complete denture

    Constructing complete denture by conventional technique of denture processing

    Device: CAD/CAM complete denture

Interventions

  • DeviceCAD/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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: 6 months

07

Study locations

2 sites
  • Faculty of Dentistry,Cairo university
    Giza, 002, Egypt
  • Cairo university
    Giza, Egypt
08

References and documents

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 23763779 ↗
  • 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. PubMed 21282882 ↗
  • 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. PubMed 8179777 ↗
  • 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. Erratum In: Medicine (Baltimore). 2017 Jan 20;96(3):e6030. doi: 10.1097/MD.0000000000006030. PubMed 28072686 ↗
  • 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. PubMed 24461946 ↗
  • 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. PubMed 26583108 ↗
  • 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. PubMed 22277604 ↗
  • 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. PubMed 25759851 ↗
  • 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. PubMed 27765399 ↗
  • 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. PubMed 22737317 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Jan 2020, 27 months.

Of 368 non-industry interventional studies with no phase under Patient Satisfaction, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 27 months is above that.

Counting every sponsor, half of 370 studies reached it within 12 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2017
First posted
Sep 13, 2017
StartActual
Oct 1, 2017
Primary completionActual
Jan 1, 2020
CompletionActual
Jan 1, 2020
Last update
Feb 3, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03281603
Lead sponsor
Cairo University
Responsible party
Mohamed Mohamed Abo Heikal (Assistant lecturer, Department of Prosthodontics, Faculty of Dentistry, MSA University, Cairo University) — Principal investigator
First posted
Sep 13, 2017
Start date
Oct 1, 2017
Primary completion
Jan 1, 2020
Completion
Jan 1, 2020
Last update
Feb 3, 2021

Study contacts

Mohamed M. Abo Heikal, PHD
principal investigator · Assistant lecturer, faculty of Dentistry, MSA University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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