Prosthesis SurvivalNCT06422260
Four-unit Implant Supported Fixed Partial Dentures Fabricated From Different Materials
An observational study of Prosthesis Survival and Bone Loss, run by Menoufia University at 1 site in Egypt.
Trial summary
Implant supported superstructure is necessary for long term success and durability of the implant itself in terms of stresses distribution and fracture strength capability. Stresses falling on an implant are too much greater than those applied on a tooth structure with a periodontal ligament offering a degree of… Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Prosthesis Survival, Bone Loss
- What is being tested?
- Prosthesis superstructure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jan 2023to 29 Jan 2025
- How long will I take part?
- 4 Years
- Phase
- Observational
- 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 30 to 50 years
- All sexes
- Adult
Study population: 60 participants who needed an implant-supported fixed partial denture (FPD) in the esthetic zone.
Who may be able to join
- No systemic diseases that might alter the tissue response to implantation.
- Mobility grade 3 at the site of the 4 lateral incisors.
- sufficient available inter-arch space
- normal maxillomandibular relation.
- no temporomandibular joint
Who cannot join
- Grade 1 or 2 mobility at the incisor's region.
- Patients with systematic diseases that contraindicate implant placement.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohammed A. El-Sawy
Al Mansurah, 12345
Mohammed A. El-Sawy, 161314522, Dr_sawy@windowslive.com
About this study
Official title: Clinical and Radiographic Outcomes of Four-unit Implant Supported Fixed Partial Dentures Fabricated From Different Materials
Implant supported superstructure is necessary for long term success and durability of the implant itself in terms of stresses distribution and fracture strength capability. Stresses falling on an implant are too much greater than those applied on a tooth structure with a periodontal ligament offering a degree of elasticity. The important mechanical and physical properties of materials used for the fabrication of dental prostheses include adequate flexural and tensile strength and modulus of elasticity, maximum fracture resistance, optimal bond strength and adequate polishability.
Read the detailed description
One objective of implant dentistry is to provide excellent esthetics and soft-tissue profiles in the esthetic zone. Esthetic requirements have focused primarily on the position, inclination, shape, and color of the restoration. However, the peri-implant soft tissue also plays a major role in the esthetics of an implant-supported restoration especially in the anterior region.
- Conditions
- Prosthesis Survival, Bone Loss
- Being tested
- Prosthesis superstructure
- Medical subject headings
- Prosthesis Failure, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthesis superstructureOther
Prosthesis superstructure for 2 implant supported short span fixed bride constructed from different materials
| Study group | Role | What they receive |
|---|---|---|
| Porcelin fused to metal (PFM) group | Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from PFM Receives: Other: Prosthesis superstructure | |
| Zirconia group | Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from ceramics Receives: Other: Prosthesis superstructure | |
| Polyetheretherketone (PEEK) group | Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from PEEK Receives: Other: Prosthesis superstructure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone loss
Measurement of alveolar bone loss around implants.
Measured: 4 years
Secondary outcomes (1)
Clinical performance of the prosthesis superstructure
Such as fracture of the prosthesis.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start19 Jan 2023
- Primary completion22 Jul 2024 (estimated)
- Study completion29 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis SurvivalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed El-Sawy, Menoufia University
- Investigators
- Mohammed A. El-Sawy, PhD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422260
- Sponsor's protocol ID
- ADMNF-0030324
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The result can be shared upon request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of Four-unit Implant Supported Fixed Partial Dentures Fabricated From Different Materials
- ClinicalTrials.gov ID
- NCT06422260
- Acronym / sponsor ID
- ADMNF-0030324
- Conditions
- Prosthesis Survival, Bone Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 22 Jul 2024 (estimated)
- Study completion
- 29 Jan 2025 (estimated)
- First posted
- 20 May 2024 (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.
Implant supported superstructure is necessary for long term success and durability of the implant itself in terms of stresses distribution and fracture strength capability. Stresses falling on an implant are too much greater than those applied on a tooth structure with a periodontal ligament offering a degree of elasticity. The important mechanical and physical properties of materials used for the fabrication of dental prostheses include adequate flexural and tensile strength and modulus of elasticity, maximum fracture resistance, optimal bond strength and adequate polishability.
Detailed description
One objective of implant dentistry is to provide excellent esthetics and soft-tissue profiles in the esthetic zone. Esthetic requirements have focused primarily on the position, inclination, shape, and color of the restoration. However, the peri-implant soft tissue also plays a major role in the esthetics of an implant-supported restoration especially in the anterior region.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Porcelin fused to metal (PFM) group | – | Other: Prosthesis superstructureEvaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from PFM |
| Zirconia group | – | Other: Prosthesis superstructureEvaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from ceramics |
| Polyetheretherketone (PEEK) group | – | Other: Prosthesis superstructureEvaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from PEEK |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- 60 participants who needed an implant-supported fixed partial denture (FPD) in the esthetic zone.
Key inclusion criteria (5 listed)
- No systemic diseases that might alter the tissue response to implantation.
- Mobility grade 3 at the site of the 4 lateral incisors.
- sufficient available inter-arch space
- normal maxillomandibular relation.
- no temporomandibular joint
Key exclusion criteria (2 listed)
- Grade 1 or 2 mobility at the incisor's region.
- Patients with systematic diseases that contraindicate implant placement.
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 |
|---|---|---|
| Prosthesis superstructureProsthesis superstructure for 2 implant supported short span fixed bride constructed from different materials | Other | Polyetheretherketone (PEEK) group, Porcelin fused to metal (PFM) group, Zirconia group |
Primary outcome
Bone loss
Time frame: 4 years
Measurement of alveolar bone loss around implants.
1 secondary outcome
Clinical performance of the prosthesis superstructure
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: No. The result can be shared upon request from the corresponding author
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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.
Mohammed A. El-Sawy, PhD principal investigator
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthesis Survival and Bone Loss, run by Menoufia 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 5 inclusion and 2 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 20 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed A. El-Sawy, PhD (01061314522, Dr_sawy@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone loss (time frame: 4 years). 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 20 May 2024.