Clincosm LogoSign in Get a demo

Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate

Sponsor
Badr University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05466305
Collaborator
(none)
12
Enrollment
2
Arms
4
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Gold plated chrome cobalt alloy
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Immunological and Microbiological Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Maxillary complete denture reinforced by chrome cobalt alloy

Completely edentulous patients treated by maxillary complete denture reinforced by chrome cobalt alloy

Device: Gold plated chrome cobalt alloy
Acrylic resin complete denture having a metal chrome cobalt palatal plate which plated by gold
Other Names:
  • Completely edentulous patients treated by maxillary complete denture reinforced by gold plated chrome cobalt alloy

    		•
    Experimental: Maxillary complete denture reinforced by gold plated chrome cobalt alloy

    Completely edentulous patients treated by maxillary complete denture reinforced by gold plated chrome cobalt alloy

    Device: Gold plated chrome cobalt alloy
    Acrylic resin complete denture having a metal chrome cobalt palatal plate which plated by gold
    Other Names:
  • Completely edentulous patients treated by maxillary complete denture reinforced by gold plated chrome cobalt alloy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Immunological assessment using Salivary IgA level through ELISA test [45 days]

      Immunological assessment of maxillary complete denture reinforced by gold plated Cr-Co alloy

    Secondary Outcome Measures

    1. Microbiological assessment using Staphylococcus Aureus, Staphylococcus Epidermis and Candida Albicans Colonization [45 days]

      Microbiological assessment of maxillary complete denture reinforced by gold plated Cr-Co alloy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Badr University

    Investigators

    • Principal Investigator: Shady M. El Naggar, PhD, Badr University in Cairo

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Shady El Naggar, Clinical Professor, Badr University
    ClinicalTrials.gov Identifier:
    NCT05466305
    Other Study ID Numbers:
    • 01012336911
    First Posted:
    Jul 20, 2022
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shady El Naggar, Clinical Professor, Badr University
    Gold
    Chrome
    Denture
    Mucosa
    Additional relevant MeSH terms:
    Stomatitis
    Stomatitis, Denture
    Cobalt

    Study Results

    No Results Posted as of Jul 21, 2022