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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
Badr University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Denture Stomatitis focused on measuring Gold, Chrome, Denture, Mucosa

Eligibility Criteria

4 Years - 65 Years (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Completely edentulous maxillary and mandibular ridges
  2. Healthy mucosa and absence of remaining roots
  3. Good physical and mental health
  4. Willing to give informed consent
  5. Normal maxilla-mandibular relationship Angle Class I
  6. Adequate bone quality and quantity in terms of width and height in the anterior maxillary mandibular ridges verified by preoperative cone beam CT
  7. Adequate inter-arch space to accommodate maxillary and mandibular implant prostheses

Exclusion Criteria:

  1. Uncontrolled diabetes
  2. Smoking habits
  3. Radiotherapy
  4. Clinical or radiographic signs of pathologic conditions
  5. Osteoporosis
  6. Patients on corticosteroids
  7. 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

    First Posted
    July 8, 2022
    Last Updated
    July 19, 2022
    Sponsor
    Badr University
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    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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