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

NCT ID: NCT05466305

Last Updated: 2022-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2022-12-01

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.

Conditions

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Denture Stomatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Maxillary complete denture reinforced by chrome cobalt alloy

Completely edentulous patients treated by maxillary complete denture reinforced by chrome cobalt alloy

Group Type PLACEBO_COMPARATOR

Gold plated chrome cobalt alloy

Intervention Type DEVICE

Acrylic resin complete denture having a metal chrome cobalt palatal plate which plated by gold

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

Group Type EXPERIMENTAL

Gold plated chrome cobalt alloy

Intervention Type DEVICE

Acrylic resin complete denture having a metal chrome cobalt palatal plate which plated by gold

Interventions

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Gold plated chrome cobalt alloy

Acrylic resin complete denture having a metal chrome cobalt palatal plate which plated by gold

Intervention Type DEVICE

Other Intervention Names

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Completely edentulous patients treated by maxillary complete denture reinforced by gold plated chrome cobalt alloy

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Badr University

OTHER

Sponsor Role lead

Responsible Party

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Shady El Naggar

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shady M. El Naggar, PhD

Role: PRINCIPAL_INVESTIGATOR

Badr University in Cairo

Central Contacts

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Shady M. El Naggar, PhD

Role: CONTACT

01122110085

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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01012336911

Identifier Type: -

Identifier Source: org_study_id

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