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StabilityNCT03119753

Dimensional Accuracy of Complete Denture With Rapid Prototyping and Conventional Method

A study testing Rapid Prototyping method of fabrication of complete denture and Conventional method of fabrication of complete denture in people with Stability, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this study we are going to compare dimensional accuracy of maxillary complete denture base fabricated by using rapid prototyping method and conventional method. We hypothesize that both techniques do not significantly differ from each other Read more about this study

Who is it for?
Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Stability
What is being tested?
Rapid Prototyping method of fabrication of complete denture and Conventional method of fabrication of complete denture
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
No sites listed yet
Study dates
10 Jun 2017to 10 Sep 2017
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 40 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ranging from 40-70 years.
  • Class I Angle's ridge relationship.
  • Literate patients are able to understand and respond to a written questionnaire in Arabic.
  • Cooperative patients with no history psychological diseases.
  • A period of at least six months should elapse from the last extraction.

Who cannot join

  • Pathological changes of residual ridges.
  • Patients with debilitating systemic diseases.
  • Patients with xerostomia.
  • Patients with temporo-mandibular joint disorders or systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
  • Patients with macroglossia or microstomia
  • Patients with flabby and flat ridges.
  • Patients with allergy to acrylic resin

About this study

Official title: Dimensional Accuracy of Maxillary Complete Denture Base Fabricated by Rapid Prototyping Method Compared With the Conventional Method: A Randomized Controlled Trial

In this study we are going to compare dimensional accuracy of maxillary complete denture base fabricated by using rapid prototyping method and conventional method.

We hypothesize that both techniques do not significantly differ from each other

Read the detailed description

The study will be carried out in the department of prosthodontics, Faculty of Oral and Dental Medicine, Cairo University. Fourteen patients will be selected from the out-patient clinic according to the inclusion and exclusion criteria, the participants will be divided randomly into two equal groups. The clinical procedures on denture fabrication for both groups will be carried out by TS. The laboratory steps will be carried out by one well trained dental technician (MA). The set of dentures will be fabricated according to the conventional method (Group C) as follow: First appointment: preliminary impression will be obtained by using irreversible hydrocolloid (alginate, cavex, normal set) in stainless steel stock trays. Trays will be augmented with warm utility wax strips (cavex) and shaped by tongue movements and manipulation of labial and buccal tissues. A special tray will be prepared with self-cured acrylic resin (Acrostone-Egypt) over the study cast poured from preliminary impression. Second appointment: A secondary impression will be made with putty rubber base as a border molding material and the final impression will be made with medium rubber base impression material. The final impressions will be poured with type 4 Hydrocal dental stone (Hydrocal Dental stone, Moldano, Bayer Leverkusen, and Germany) to obtain the master cast which will be used for constructing self-cured acrylic resin trial denture bases that will carry a wax occlusion rim. Third appointment: A face bow record will be made to transfer the relation of the maxilla to the temporomandibular joint. Maxilla-mandibular relationship will be recorded using maxillary and mandibular occlusion rims formed over the master cast. Fourth appointment: Setting of artificial teeth will be performed and trial dentures will be tried in inside patients' mouth. Fifth appointment: The finished and polished dentures will be delivered immediately after the necessary adjustments and instructions regarding hygiene and maintenance. The other set of dentures (Group R) will be fabricated according to the rapid prototyping Stereo lithography (SLA) method. The detailed procedures are the same as described for the conventional method (Group C) except for that master casts will be scanned to fabricate the denture bases. The obtained master casts will be used to attach three stainless steel pins before fabrication of the denture bases to assess the linear dimensional changes at the following positions; A: pin at the incisive papilla B: pin at the right second molar area C: pin at the left second molar area Digital caliper will be used to measure distance between the points (AB, BC and CA) and each measurement will be repeated five times. The mean of five readings will be taken as a single reading to decrease the percentage of error. For Conventional Methods: Self-cured acrylic resin trial denture bases will be constructed on the obtained master casts, then processing of the final denture bases by conventional clamping method cured by long curing cycle (74º C for 8 hours) using heat-cured poly-methyl methacrylate (PMMA) resin material. The position of the pins will be recorded into the denture bases so that the linear changes could be measured. For Rapid Prototyping Method: the master casts will be scanned using DENTAL WINGS eco-scan 3, using laser technology for scanning, after spraying the stainless steel pins with scanning spray to be recorded into the denture base. Virtual model will be obtained for fabrication of denture bases. Denture base will be designed and modified on the virtual model, then it will be printed using ZENITH-3D Printer using Urethane acrylate oligomer based photo-polymerized resin. After finishing and polishing of the conventional denture bases and printing of rapid prototyped denture bases, evaluation of linear dimensional changes will be carried out through recording five reading for each of the three dimensions and a mean value will be calculated using digital caliper. This value will be calculated for the master model. The same procedure will be repeated for the two experimental groups (A\&B). The dimensional changes will be determined based on the difference between the two values for each method and all records will be tabulated and analysis will be done for the differences between records.

Conditions
Stability
Being tested
Rapid Prototyping method of fabrication of complete denture, Conventional method of fabrication of complete denture
Keywords
Rapid Prototyping technique, complete denture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rapid Prototyping method of fabrication of complete dentureDevice

    For Rapid Prototyping Method of fabrication of complete denture : the master casts will be scanned using DENTAL WINGS eco-scan 3, using laser technology for scanning, after spraying the stainless steel pins with scanning spray to be recorded into the denture base. Virtual model will be obtained for fabrication of denture bases. Denture base will be designed and modified on the virtual model, then it will be printed using ZENITH-3D Printer using Urethane acrylate oligomer based photo-polymerized resin.

  • Conventional method of fabrication of complete dentureDevice

    For Conventional Method of fabrication of complete denture: Self-cured acrylic resin trial denture bases will be constructed on the obtained master casts, then processing of the final denture bases by conventional clamping method cured by long curing cycle (74º C for 8 hours) using heat-cured poly-methyl methacrylate (PMMA) resin material. The position of the pins will be recorded into the denture bases so that the linear changes could be measured.

Study groups in NCT03119753
Study groupRoleWhat they receive
Group RExperimentalRapid Prototyping method of fabrication of complete denture: the master casts will be scanned using DENTAL WINGS eco-scan 3, using laser technology for scanning, after spraying the stainless steel pins with scanning spray to be recorded into the denture base. Virtual model will be obtained for fabrication of denture bases. Denture base will be designed and modified on the virtual model, then it will be printed using ZENITH-3D Printer using Urethane acrylate oligomer based photo-polymerized resin.
Receives: Device: Rapid Prototyping method of fabrication of complete denture
Group CActive comparatorConventional method of fabrication of complete denture: Self-cured acrylic resin trial denture bases will be constructed on the obtained master casts, then processing of the final denture bases by conventional clamping method cured by long curing cycle (74º C for 8 hours) using heat-cured poly-methyl methacrylate (PMMA) resin material. The position of the pins will be recorded into the denture bases so that the linear changes could be measured.
Receives: Device: Conventional method of fabrication of complete denture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. dimensional accuracy of complete denture

    dimensional accuracy of complete denture will be measured using digital caliper

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2017
  2. Study start10 Jun 2017 (estimated)
  3. Primary completion10 Jul 2017 (estimated)
  4. Study completion10 Sep 2017 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03119753
Sponsor's protocol ID
8790
Status last verified
Apr 2017
First submitted
11 Apr 2017
Last updated
19 Apr 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Rapid Prototyping method of fabrication of complete denture and Conventional method of fabrication of complete denture in people with Stability, run by Cairo University.

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 5 inclusion and 7 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 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

dimensional accuracy of complete denture (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 19 Apr 2017.

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