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

Not Applicable

• Conditions: Denture Stomatitis
• Interventions: Device: Gold plated chrome cobalt alloy

• Registration Number: NCT05466305
• Lead Sponsor: Badr University

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.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-18
• Last Update Submitted: 2022-07-19
• Study First Posted: 2022-07-20
• Last Update Posted: 2022-07-21
• Study Start: 2022-08-01
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maxillary complete denture reinforced by chrome cobalt alloy	Gold plated chrome cobalt alloy	Completely edentulous patients treated by maxillary complete denture reinforced by chrome cobalt alloy
Maxillary complete denture reinforced by gold plated chrome cobalt alloy	Gold plated chrome cobalt alloy	Completely edentulous patients treated by maxillary complete denture reinforced by gold plated chrome cobalt alloy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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