Clinical trial NCT05466305: Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate
Official title: Immunological and Microbiological Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Denture Stomatitis
Keywords: Gold
Chrome
Denture
Mucosa
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 12
Sex: MALE
Minimum age (years): 4
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Immunological assessment using Salivary IgA level through ELISA test
timeFrame: 45 days
Secondary outcomes:
measure: Microbiological assessment using Staphylococcus Aureus, Staphylococcus Epidermis and Candida Albicans Colonization
timeFrame: 45 days
Other outcomes:
Locations:
Study officials:
affiliation: Badr University in Cairo
name: Shady M. El Naggar, PhD
role: PRINCIPAL_INVESTIGATOR
References: