Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate
Primary Purpose
Denture Stomatitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gold plated chrome cobalt alloy
Sponsored by
About this trial
This is an interventional prevention trial for Denture Stomatitis focused on measuring Gold, Chrome, Denture, Mucosa
Eligibility Criteria
Inclusion Criteria:
- Completely edentulous maxillary and mandibular ridges
- Healthy mucosa and absence of remaining roots
- Good physical and mental health
- Willing to give informed consent
- Normal maxilla-mandibular relationship Angle Class I
- Adequate bone quality and quantity in terms of width and height in the anterior maxillary mandibular ridges verified by preoperative cone beam CT
- Adequate inter-arch space to accommodate maxillary and mandibular implant prostheses
Exclusion Criteria:
- Uncontrolled diabetes
- Smoking habits
- Radiotherapy
- Clinical or radiographic signs of pathologic conditions
- Osteoporosis
- Patients on corticosteroids
- Bruxism
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Maxillary complete denture reinforced by chrome cobalt alloy
Maxillary complete denture reinforced by gold plated chrome cobalt alloy
Arm Description
Completely edentulous patients treated by maxillary complete denture reinforced by chrome cobalt alloy
Completely edentulous patients treated by maxillary complete denture reinforced by gold plated chrome cobalt alloy
Outcomes
Primary Outcome Measures
Immunological assessment using Salivary IgA level through ELISA test
Immunological assessment of maxillary complete denture reinforced by gold plated Cr-Co alloy
Secondary Outcome Measures
Microbiological assessment using Staphylococcus Aureus, Staphylococcus Epidermis and Candida Albicans Colonization
Microbiological assessment of maxillary complete denture reinforced by gold plated Cr-Co alloy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05466305
Brief Title
Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate
Official Title
Immunological and Microbiological Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Badr University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Gold is widely used in prosthetics. Its use ranges from being employed in the fabrication of removable dentures, where the inner surface permanently touching oral cavity tissues, through to fixed dentures, and even some structures of certain implantological systems. All such items can be made of galvanized gold. Thus, new technologies have made gold and its alloys a kind of a universal material.
Detailed Description
Gold is widely used in prosthetics. Its use ranges from being employed in the fabrication of removable dentures, where the inner surface permanently touching oral cavity tissues, through to fixed dentures, and even some structures of certain implantological systems. All such items can be made of galvanized gold. Thus, new technologies have made gold and its alloys a kind of a universal material.
Using metal alloys (gold alloys included) to make the framework for removable dentures is much better than using acrylic resin. This because the alloys have almost no destructive influence over the dentures bearing area. Due to the precise way it is made, the stability of shape, the lack of internal stresses and the close contact with the dentures bearing area, it is possible to achieve very good retention of the denture over a long span of time. Another advantage is that the metal framework conducts temperature changes and this facilitates keeping the tissues in good health. Also, a denture metal framework makes it much easier for the patient to maintain good oral hygiene by lowering the risk of plaque accumulation. However, a metal framework has a disadvantage as well - prosthesis relining cannot be made.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Denture Stomatitis
Keywords
Gold, Chrome, Denture, Mucosa
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Maxillary complete denture reinforced by chrome cobalt alloy
Arm Type
Placebo Comparator
Arm Description
Completely edentulous patients treated by maxillary complete denture reinforced by chrome cobalt alloy
Arm Title
Maxillary complete denture reinforced by gold plated chrome cobalt alloy
Arm Type
Experimental
Arm Description
Completely edentulous patients treated by maxillary complete denture reinforced by gold plated chrome cobalt alloy
Intervention Type
Device
Intervention Name(s)
Gold plated chrome cobalt alloy
Other Intervention Name(s)
Completely edentulous patients treated by maxillary complete denture reinforced by gold plated chrome cobalt alloy
Intervention Description
Acrylic resin complete denture having a metal chrome cobalt palatal plate which plated by gold
Primary Outcome Measure Information:
Title
Immunological assessment using Salivary IgA level through ELISA test
Description
Immunological assessment of maxillary complete denture reinforced by gold plated Cr-Co alloy
Time Frame
45 days
Secondary Outcome Measure Information:
Title
Microbiological assessment using Staphylococcus Aureus, Staphylococcus Epidermis and Candida Albicans Colonization
Description
Microbiological assessment of maxillary complete denture reinforced by gold plated Cr-Co alloy
Time Frame
45 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Completely edentulous maxillary and mandibular ridges
Healthy mucosa and absence of remaining roots
Good physical and mental health
Willing to give informed consent
Normal maxilla-mandibular relationship Angle Class I
Adequate bone quality and quantity in terms of width and height in the anterior maxillary mandibular ridges verified by preoperative cone beam CT
Adequate inter-arch space to accommodate maxillary and mandibular implant prostheses
Exclusion Criteria:
Uncontrolled diabetes
Smoking habits
Radiotherapy
Clinical or radiographic signs of pathologic conditions
Osteoporosis
Patients on corticosteroids
Bruxism
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shady M. El Naggar, PhD
Phone
01122110085
Email
shady.mahmoud@buc.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shady M. El Naggar, PhD
Organizational Affiliation
Badr University in Cairo
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate
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