Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate
Immunological and Microbiological Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate
1 other identifier
interventional
12
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2022
CompletedFirst Posted
Study publicly available on registry
July 20, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJuly 21, 2022
July 1, 2022
3 months
July 8, 2022
July 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immunological assessment using Salivary IgA level through ELISA test
Immunological assessment of maxillary complete denture reinforced by gold plated Cr-Co alloy
45 days
Secondary Outcomes (1)
Microbiological assessment using Staphylococcus Aureus, Staphylococcus Epidermis and Candida Albicans Colonization
45 days
Study Arms (2)
Maxillary complete denture reinforced by chrome cobalt alloy
PLACEBO COMPARATORCompletely edentulous patients treated by maxillary complete denture reinforced by chrome cobalt alloy
Maxillary complete denture reinforced by gold plated chrome cobalt alloy
EXPERIMENTALCompletely edentulous patients treated by maxillary complete denture reinforced by gold plated chrome cobalt alloy
Interventions
Acrylic resin complete denture having a metal chrome cobalt palatal plate which plated by gold
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Uncontrolled diabetes
- Smoking habits
- Radiotherapy
- Clinical or radiographic signs of pathologic conditions
- Osteoporosis
- Patients on corticosteroids
- Bruxism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Badr Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shady M. El Naggar, PhD
Badr University in Cairo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
July 8, 2022
First Posted
July 20, 2022
Study Start
August 1, 2022
Primary Completion
November 1, 2022
Study Completion
December 1, 2022
Last Updated
July 21, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share