Denture StomatitisNCT05466305
Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate
A study testing Gold plated chrome cobalt alloy in people with Denture Stomatitis, run by Badr University.
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. Read more about this study
- Who is it for?
- Ages 4 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Denture Stomatitis
- What is being tested?
- Gold plated chrome cobalt alloy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 65 years
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Completely edentulous maxillary and mandibular ridges
- Healthy mucosa and absence of remaining roots
- Good physical and mental health
- Willing to give informed consent
- Normal maxilla-mandibular relationship Angle Class I
- Adequate bone quality and quantity in terms of width and height in the anterior maxillary mandibular ridges verified by preoperative cone beam CT
- Adequate inter-arch space to accommodate maxillary and mandibular implant prostheses
Who cannot join
- Uncontrolled diabetes
- Smoking habits
- Radiotherapy
- Clinical or radiographic signs of pathologic conditions
- Osteoporosis
- Patients on corticosteroids
- Bruxism
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Denture Stomatitis
- Being tested
- Gold plated chrome cobalt alloy
- Keywords
- Gold, Chrome, Denture, Mucosa
- Medical subject headings
- Stomatitis, Denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gold plated chrome cobalt alloyDevice
Also called Completely edentulous patients treated by maxillary complete denture reinforced by gold plated chrome cobalt alloy
Acrylic resin complete denture having a metal chrome cobalt palatal plate which plated by gold
| Study group | Role | What they receive |
|---|---|---|
| Maxillary complete denture reinforced by chrome cobalt alloy | Placebo comparator | Completely edentulous patients treated by maxillary complete denture reinforced by chrome cobalt alloy Receives: Device: Gold plated chrome cobalt alloy |
| Maxillary complete denture reinforced by gold plated chrome cobalt alloy | Experimental | Completely edentulous patients treated by maxillary complete denture reinforced by gold plated chrome cobalt alloy Receives: Device: Gold plated chrome cobalt alloy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological assessment using Salivary IgA level through ELISA test
Immunological assessment of maxillary complete denture reinforced by gold plated Cr-Co alloy
Measured: 45 days
Secondary outcomes (1)
Microbiological assessment using Staphylococcus Aureus, Staphylococcus Epidermis and Candida Albicans Colonization
Microbiological assessment of maxillary complete denture reinforced by gold plated Cr-Co alloy
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denture StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady El Naggar, Badr University
- Investigators
- Shady M. El Naggar, PhD, Principal investigator, Badr University in Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466305
- Sponsor's protocol ID
- 01012336911
- Status last verified
- Jul 2022
- First submitted
- 8 Jul 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological and Microbiological Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate
- ClinicalTrials.gov ID
- NCT05466305
- Acronym / sponsor ID
- 01012336911
- Conditions
- Denture Stomatitis
- Keywords
- Gold, Chrome, Denture, Mucosa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maxillary complete denture reinforced by chrome cobalt alloy | Placebo comparator | Device: Gold plated chrome cobalt alloyCompletely edentulous patients treated by maxillary complete denture reinforced by chrome cobalt alloy |
| Maxillary complete denture reinforced by gold plated chrome cobalt alloy | Experimental | Device: Gold plated chrome cobalt alloyCompletely edentulous patients treated by maxillary complete denture reinforced by gold plated chrome cobalt alloy |
Who may qualify
- Ages
- 4 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Completely edentulous maxillary and mandibular ridges
- Healthy mucosa and absence of remaining roots
- Good physical and mental health
- Willing to give informed consent
- Normal maxilla-mandibular relationship Angle Class I
Key exclusion criteria (7 listed)
- Uncontrolled diabetes
- Smoking habits
- Radiotherapy
- Clinical or radiographic signs of pathologic conditions
- Osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gold plated chrome cobalt alloyAlso: Completely edentulous patients treated by maxillary complete denture reinforced by gold plated chrome cobalt alloyAcrylic resin complete denture having a metal chrome cobalt palatal plate which plated by gold | Device | Maxillary complete denture reinforced by chrome cobalt alloy, Maxillary complete denture reinforced by gold plated chrome cobalt alloy |
Primary outcome
Immunological assessment using Salivary IgA level through ELISA test
Time frame: 45 days
Immunological assessment of maxillary complete denture reinforced by gold plated Cr-Co alloy
1 secondary outcome
Microbiological assessment using Staphylococcus Aureus, Staphylococcus Epidermis and Candida Albicans Colonization
Time frame: 45 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Denture Stomatitis
Not yet recruiting
Development of a Sanitizing Tablet for Removable Partial Dentures
Denture Stomatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shady M. El Naggar, PhD principal investigator
Badr University in Cairo
Questions about this trial
What is this clinical trial studying?
A study testing Gold plated chrome cobalt alloy in people with Denture Stomatitis, run by Badr University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shady M. El Naggar, PhD (01122110085, shady.mahmoud@buc.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological assessment using Salivary IgA level through ELISA test (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.