Retention of Computer Aided Design and Computer Aided Manufacturing Titanium Versus Co/Cr Single Dentures.

September 18, 2018 updated by: Amr Gamal Ismail Mohamed, Cairo University

Retention of Computer Aided Design and Computer Aided Manufacturing Titanium Versus Cobalt/Chromium Maxillary Single Denture Bases: A Randomized Clinical Trial.

  • Steps in short: Undergoing the conventional steps of maxillary single denture construction till the step of framework construction that will be designed and constructed using CAD/CAM after optical scanning of the master cast ( 2 frameworks to cover the palate and crest of the ridge : one made of titanium and the other made of cobalt/chromium) then conventional steps will be undergone including bite, Try-in and delivery ending by measuring the denture retention.
  • Number of visits & follow up period :

Visits: will be 5-6 visits for each patient. Follow up period: 6.5 months (immediately post-insertion then after 1 week then after 3 months for the first type then 2 weeks washout period and the same for the second type)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study will be carried out in the department of prosthodontics-cairo university. Patients will be selected from the out-patient clinic according to the inclusion criteria, The primary impression will be made with alginate (cavex-normal set) and will be border-molded to get the acceptable extension and border thickness, a tray will be prepared with self-activated acrylic resin over the study cast. A secondary impression will be made with heavy putty consistency as a border molding material and the final impression will be made with light rubber base (3M) impression material, Then Pouring of the final impressions with type 4 Hydrocal dental stone (Hydrocal Dental stone, Bayer, and Germany). Master casts will be optically scanned using 3 shape optical scanner. Duplication of master casts will be done using silicone duplicating material. Titanium and cobalt/chromium metallic bases will be milled using 3shape milling machine to cover the palate with mesh extension over the ridge. They will be tried intra-orally regarding sitting and stability. Occlusal rim will be set on titanium metallic base then face bow record will be recorded then mounting the maxillary master cast. Centric relation will be registered then mounting of the mandibular cast will be done. The same will be done for the duplicate cast with the Cobalt/Chromium metallic base. Then Setting of the anatomical teeth for both master casts then try-in stage will be checked intra-orally then packing of cast and duplicate cast with conventional heat cured acrylic resin (Dentsply, Dentsply limited, Weybridge, Surrey. England) after flasking each denture will be finished.

The dentures will be delivered, then the assessment will be immediately and after 1 week then after 3 months that a hook screw with its nut (Digital force gauge instrument, model 475044) will be secured in the polished mid-palatal surface of the upper denture using metallic adhesive to record the amount of the force required for dislodgment. The pull end of the digital force gauge device will be connected to the hook positioned at maxillary dentures for one type of the two dentures and will be pulled vertically until denture dislodgement occurred, then the patient will take off his first type of denture for 2 weeks as a washout period then the second type of denture will be delivered and the same assessment will be done.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Manyal
      • Cairo, Manyal, Egypt, 12554
        • Faculty of Oral and Dental Medicine

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

Ages Eligible for Study

40 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completely edentulous maxillary arch and fully dentate mandibular arch with adequate interarch space.
  • The edentulous ridges should be covered by firm healthy mucosa.
  • Angle class I maxillomandibular relationship
  • Healthy and co-operative patients.

Exclusion Criteria:

  • Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than I 0 cigarettes/day).
  • Previous history of radiotherapy or chemotherapy.
  • Any skeletal problem dictates surgical intervention.

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention arm
the group of participants will take the CAD/CAM titanium denture bases and assessment during and after the first 3 months after delivery of the first type.
Device: CAD/CAM titanium denture base
metallic denture base made of titanium
Experimental: intervention arm 2
the same group of participants will take the CAD/CAM cobalt/chromium denture bases and assessment during and after the second 3 months after delivery of the second type.
Device: CAD/CAM cobalt/chromium denture bases
metallic denture bases made of cobalt/chromium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention of single denture
Time Frame: 6.5 months
the dislodgement force of the denture will be assessed
6.5 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: iman rady, professor, head of evidence based dentistry

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)

December 1, 2018

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

September 30, 2019

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

September 19, 2018

Last Update Submitted That Met QC Criteria

September 18, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28912240102212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

it will not be shared with other researchers except my supervisor

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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