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

Primary Purpose

Edentulous Mouth

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
CAD/CAM titanium denture base
CAD/CAM cobalt/chromium denture bases
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Edentulous Mouth focused on measuring Dislodgement force, Digital denture, CAD/CAM metallic dentures

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Oral and Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

intervention arm

intervention arm 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Retention of single denture
the dislodgement force of the denture will be assessed

Secondary Outcome Measures

Full Information

First Posted
September 17, 2018
Last Updated
September 18, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03675594
Brief Title
Retention of Computer Aided Design and Computer Aided Manufacturing Titanium Versus Co/Cr Single Dentures.
Official Title
Retention of Computer Aided Design and Computer Aided Manufacturing Titanium Versus Cobalt/Chromium Maxillary Single Denture Bases: A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Mouth
Keywords
Dislodgement force, Digital denture, CAD/CAM metallic dentures

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
the participants will not be told which type they received till obtaining the final results of both types.Outcomes will be collected only by the supervisor.
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
intervention arm 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CAD/CAM titanium denture base
Intervention Description
metallic denture base made of titanium
Intervention Type
Device
Intervention Name(s)
CAD/CAM cobalt/chromium denture bases
Intervention Description
metallic denture bases made of cobalt/chromium
Primary Outcome Measure Information:
Title
Retention of single denture
Description
the dislodgement force of the denture will be assessed
Time Frame
6.5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amal el rekaby, professor
Phone
0122258794
Email
prosthetic@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed saad, lecturer
Phone
0118976584
Email
ahmed_saad@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
iman rady, professor
Organizational Affiliation
head of evidence based dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Oral and Dental Medicine
City
Cairo
State/Province
Manyal
ZIP/Postal Code
12554
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
atef shaker, dean
Phone
(+202) 23642938
Email
dean@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
it will not be shared with other researchers except my supervisor

Learn more about this trial

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

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