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

Denture Stomatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05466305
• Other study ID #: 01012336911
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2022
• Source: Badr University
• Contact: Shady M. El Naggar, PhD
• Phone: 01122110085
• Email: shady.mahmoud[@]buc.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: December 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 4 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Denture Stomatitis
• Stomatitis
• Stomatitis, Denture

Intervention

Device:
• Gold plated chrome cobalt alloy
Acrylic resin complete denture having a metal chrome cobalt palatal plate which plated by gold

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Badr University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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