Dimensional Accuracy of Complete Denture With Rapid Prototyping and Conventional Method

April 14, 2017 updated by: Tarek Salah Hashim Ali, Cairo University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group R
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.
Device: Rapid Prototyping method of fabrication of complete denture
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.
Active Comparator: Group C
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.
Device: Conventional method of fabrication of complete denture
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
dimensional accuracy of complete denture
Time Frame: 1 month
dimensional accuracy of complete denture will be measured using digital caliper
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 8790 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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