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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immunological and Microbiological Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate

Conditions
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Denture Stomatitis

Intervention / Treatment
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* Device: Gold plated chrome cobalt alloy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Maxillary complete denture reinforced by chrome cobalt alloy<br>Completely edentulous patients treated by maxillary complete denture reinforced by chrome cobalt alloy | Device: Gold plated chrome cobalt alloy<br>* Acrylic resin complete denture having a metal chrome cobalt palatal plate which plated by gold<br>* 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<br>Completely edentulous patients treated by maxillary complete denture reinforced by gold plated chrome cobalt alloy | Device: Gold plated chrome cobalt alloy<br>* Acrylic resin complete denture having a metal chrome cobalt palatal plate which plated by gold<br>* Other names: Completely edentulous patients treated by maxillary complete denture reinforced by gold plated chrome cobalt alloy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological assessment using Staphylococcus Aureus, Staphylococcus Epidermis and Candida Albicans Colonization | Microbiological assessment of maxillary complete denture reinforced by gold plated Cr-Co alloy | 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gold, Chrome, Denture, Mucosa