Prosthesis DurabilityNCT06116877
Effect of Adding Zirconium Oxide Nanoparticles to Printable Implant Overdenture
A study testing implant supported overdenture in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.
Trial summary
This clinical study will be conducted to evaluate and compare non-modified printable acrylic resin base material and modified printable acrylic resin base material with zirconia oxide nanoparticles for a 2-implant retained complete overdenture regarding:Surface roughness; microbiological assessment of denture base… Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Durability
- What is being tested?
- implant supported overdenture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2022to 11 Aug 2023
- 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Patients are healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This will be achieved through medical history and clinical examination by physician.
- 2. They will have completely edentulous jaws for at least 1 year. 3. They will be of angle's class I maxillo-mandibular relationship and have upper and lower completely edentulous arches.
- 4. Residual alveolar ridges covered with healthy firm mucosa. 5. All included patients will have sufficient available length and width of mandibular bone to accommodate conventional implant. (At least 5 mm buccolingual width and 12 mm vertical height of bone.
Who cannot join
- Patients with chronic systemic diseases that affect bone metabolism
- Uncontrolled diabetic patients
- Patients with TMJ dysfunction
- Smokers
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University ,Faculty of dentistry
Al Mansurah, P.O.Box:35516
About this study
Official title: Effect of Adding Zirconium Oxide Nanoparticles to Printable Implant Overdenture Acrylic Resin Base Material. Clinical Comparative Study
This clinical study will be conducted to evaluate and compare non-modified printable acrylic resin base material and modified printable acrylic resin base material with zirconia oxide nanoparticles for a 2-implant retained complete overdenture regarding:Surface roughness; microbiological assessment of denture base microbiological analysis peri-implant soft tissue health around used implants
- Conditions
- Prosthesis Durability
- Being tested
- implant supported overdenture
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant supported overdentureProcedure or surgery
mandibular 2-implant retained overdenture of non-modified printable acrylate resins base material with Zirconium oxide nanoparticles
| Study group | Role | What they receive |
|---|---|---|
| Group (I) non modified | Active comparator | Five patients will receive mandibular 2-implant retained overdentures of non-modified printable acrylic resin base material. Receives: Procedure: implant supported overdenture |
| Group (II) modified | Active comparator | Five patients will receive mandibular 2-implant retained overdentures of modified printable acrylate resin base material with zirconium oxide nanoparticles. Receives: Procedure: implant supported overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface roughness
Surface roughness: will be evaluated using profilometer device
Measured: one year
Microbiological assessment
Microbiological assessment of denture base surface microbiological analysis
Measured: one year
Peri-implant soft tissue health
was evaluated using scores for plaque and gingival bleeding
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start3 Mar 2022
- Primary completion1 Apr 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis DurabilityStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116877
- Sponsor's protocol ID
- A03010322
- Status last verified
- Oct 2023
- First submitted
- 31 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Zirconium Oxide Nanoparticles to Printable Implant Overdenture Acrylic Resin Base Material. Clinical Comparative Study
- ClinicalTrials.gov ID
- NCT06116877
- Acronym / sponsor ID
- A03010322
- Conditions
- Prosthesis Durability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 3 Nov 2023 (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.
This clinical study will be conducted to evaluate and compare non-modified printable acrylic resin base material and modified printable acrylic resin base material with zirconia oxide nanoparticles for a 2-implant retained complete overdenture regarding:Surface roughness; microbiological assessment of denture base microbiological analysis peri-implant soft tissue health around used implants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (I) non modified | Active comparator | Procedure: implant supported overdentureFive patients will receive mandibular 2-implant retained overdentures of non-modified printable acrylic resin base material. |
| Group (II) modified | Active comparator | Procedure: implant supported overdentureFive patients will receive mandibular 2-implant retained overdentures of modified printable acrylate resin base material with zirconium oxide nanoparticles. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Patients are healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This will be achieved through medical history and clinical examination by physician.
- 2. They will have completely edentulous jaws for at least 1 year. 3. They will be of angle's class I maxillo-mandibular relationship and have upper and lower completely edentulous arches.
- 4. Residual alveolar ridges covered with healthy firm mucosa. 5. All included patients will have sufficient available length and width of mandibular bone to accommodate conventional implant. (At least 5 mm buccolingual width and 12 mm vertical height of bone.
Key exclusion criteria (4 listed)
- Patients with chronic systemic diseases that affect bone metabolism
- Uncontrolled diabetic patients
- Patients with TMJ dysfunction
- Smokers
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 |
|---|---|---|
| implant supported overdenturemandibular 2-implant retained overdenture of non-modified printable acrylate resins base material with Zirconium oxide nanoparticles | Procedure or surgery | Group (I) non modified, Group (II) modified |
Primary outcome
Surface roughness
Time frame: one year
Surface roughness: will be evaluated using profilometer device
Microbiological assessment
Time frame: one year
Microbiological assessment of denture base surface microbiological analysis
Peri-implant soft tissue health
Time frame: one year
was evaluated using scores for plaque and gingival bleeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant supported overdenture in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surface roughness (time frame: one year). The study lists 3 primary outcomes in all. 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 3 Nov 2023.