- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06422260
Four-unit Implant Supported Fixed Partial Dentures Fabricated From Different Materials
May 17, 2024 updated by: Mohammed El-Sawy, Menoufia University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohammed A. El-Sawy, PhD
- Phone Number: 01061314522
- Email: Dr_sawy@windowslive.com
Study Contact Backup
- Name: Mohammed T. Khater, PhD
- Phone Number: 01003854552
- Email: mohamed.tarek67@dent.menofia.edu.eg
Study Locations
-
-
-
Mansoura, Egypt, 12345
- Recruiting
- Mohammed A. El-Sawy
-
Contact:
- Mohammed A. El-Sawy
- Phone Number: 161314522
- Email: Dr_sawy@windowslive.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
60 participants who needed an implant-supported fixed partial denture (FPD) in the esthetic zone.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Grade 1 or 2 mobility at the incisor's region.
- Patients with systematic diseases that contraindicate implant placement.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Porcelin fused to metal (PFM) group
Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from PFM
|
Prosthesis superstructure for 2 implant supported short span fixed bride constructed from different materials
|
|
Zirconia group
Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from ceramics
|
Prosthesis superstructure for 2 implant supported short span fixed bride constructed from different materials
|
|
Polyetheretherketone (PEEK) group
Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from PEEK
|
Prosthesis superstructure for 2 implant supported short span fixed bride constructed from different materials
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone loss
Time Frame: 4 years
|
Measurement of alveolar bone loss around implants.
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical performance of the prosthesis superstructure
Time Frame: 4 years
|
Such as fracture of the prosthesis.
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohammed A. El-Sawy, PhD, Menoufia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 19, 2023
Primary Completion (Estimated)
July 22, 2024
Study Completion (Estimated)
January 29, 2025
Study Registration Dates
First Submitted
May 8, 2024
First Submitted That Met QC Criteria
May 17, 2024
First Posted (Actual)
May 20, 2024
Study Record Updates
Last Update Posted (Actual)
May 20, 2024
Last Update Submitted That Met QC Criteria
May 17, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADMNF-0030324
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The result can be shared upon request from the corresponding author
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.