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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Denture Stomatitis
• Intervention / Treatment: Device: Gold plated chrome cobalt alloy

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 Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shady M. El Naggar, PhD; Phone Number: 01122110085; Email: shady.mahmoud@buc.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Denture; Gold; Chrome; Mucosa
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Stomatitis; Stomatitis, Denture; Physiological Effects of Drugs; Trace Elements; Micronutrients; Cobalt
• Other Study ID Numbers: 01012336911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No