Bone LossNCT06071689
Radiographic Evaluation of All-on-4 Implant Prosthesis With Different Materials and Bar Construction Techniques
A study testing screw retained prosthesis in people with Bone Loss, run by Mansoura University at 1 site in Egypt.
Trial summary
Eighteen patients will be selected from the outpatient clinic of the Prosthodontic Department, Faculty of Dentistry, Mansoura University seeking prosthetic rehabilitation. patients will be randomly divided into three groups according to the framework materials: PEEK, Soft metal, and selective laser melting… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- screw retained prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jun 2023to 20 Sep 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completely edentulous maxillary ridges and mandibular arch with four implants placed according to the All-on-4 distribution. All patients were recruited from the previous study.
- All selected patients will be with sufficient inter-arch space and restorative space.
- All selected patients will have healthy ridges covered by the compressible oral mucosa and free from any ridge flabbiness.
Who cannot join
- History of para-functional habits (Bruxism, clenching), smoking, and alcoholism.
- History of radiation therapy in the head and neck region.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiographic Evaluation of the Peri-implant Circumferential Bone Level and Bone Changes in the Posterior Mandible of All-on-4 Implant Prosthesis With Different Materials and Bar Construction Techniques
Eighteen patients will be selected from the outpatient clinic of the Prosthodontic Department, Faculty of Dentistry, Mansoura University seeking prosthetic rehabilitation.
patients will be randomly divided into three groups according to the framework materials: PEEK, Soft metal, and selective laser melting construction.
Read the detailed description
All patients will receive conventional maxillary and mandibular complete dentures.
- The mandibular denture will be modified by shortening the flanges and cutting the posterior part till the 1st molar then 3D scanned for recording the correct dimension of each tooth to be concerned during the construction of the superstructure and the final prosthesis.
- Abutment level impression will be made, and the resultant cast will be 3D scanned for CAD/CAM construction of superstructure with abutments.
- patients will be randomly divided into three groups according to the framework materials: PEEK, Soft metal, and selective laser melting construction.
- The fit of the framework will be verified intraorally, and the final prosthesis will be digitally constructed; according to the dimensions of the scanned denture; to fit over the framework.
Evaluation Radiographic evaluation of circumferential bone level around implants and bone changes in the posterior mandible will be done using CBCT at one, two, three, and five years after insertion of the final prosthesis.
- Conditions
- Bone Loss
- Being tested
- screw retained prosthesis
- Keywords
- All-on-Four implant, PEEK framework, Soft metal, Selective laser melting
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screw retained prosthesisDevice
Also called hybrid prosthsis
all-on-4 screw-retained prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| PEEK group | Active comparator | patients receive all-on-4 prostheses constructed from CAD/CAM milled PEEK framework. Receives: Device: screw retained prosthesis |
| Soft metal group | Active comparator | patients receive all-on-4 prostheses constructed from CAD/CAM milled soft metal framework. Receives: Device: screw retained prosthesis |
| selective laser melting group | Active comparator | patients receive all-on-4 prostheses constructed from 3D printed selective laser melting Co-Cr framework. Receives: Device: screw retained prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone changes
circumferential peri-implant bone changes in mm
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start23 Jun 2023
- Primary completion12 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone LossStudies 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
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khloud Ezzat, PhD, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071689
- Sponsor's protocol ID
- M0103023RP
- Status last verified
- Sep 2023
- First submitted
- 1 Oct 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mourad KE, Rashed NHAH, Altonbary GY, Fattah Hegazy SA. Five years of radiographic evaluation for the peri-implant bone changes of all-on-four implant prostheses constructed from different framework materials using different digital construction techniques. BMC Oral Health. 2024 Aug 7;24(1):910. doi: 10.1186/s12903-024-04642-7.
PubMed 39112988
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Evaluation of the Peri-implant Circumferential Bone Level and Bone Changes in the Posterior Mandible of All-on-4 Implant Prosthesis With Different Materials and Bar Construction Techniques
- ClinicalTrials.gov ID
- NCT06071689
- Acronym / sponsor ID
- M0103023RP
- Conditions
- Bone Loss
- Keywords
- All-on-Four implant, PEEK framework, Soft metal, Selective laser melting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 6 Oct 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.
Eighteen patients will be selected from the outpatient clinic of the Prosthodontic Department, Faculty of Dentistry, Mansoura University seeking prosthetic rehabilitation.
patients will be randomly divided into three groups according to the framework materials: PEEK, Soft metal, and selective laser melting construction.
Detailed description
All patients will receive conventional maxillary and mandibular complete dentures.
- The mandibular denture will be modified by shortening the flanges and cutting the posterior part till the 1st molar then 3D scanned for recording the correct dimension of each tooth to be concerned during the construction of the superstructure and the final prosthesis.
- Abutment level impression will be made, and the resultant cast will be 3D scanned for CAD/CAM construction of superstructure with abutments.
- patients will be randomly divided into three groups according to the framework materials: PEEK, Soft metal, and selective laser melting construction.
- The fit of the framework will be verified intraorally, and the final prosthesis will be digitally constructed; according to the dimensions of the scanned denture; to fit over the framework.
Evaluation Radiographic evaluation of circumferential bone level around implants and bone changes in the posterior mandible will be done using CBCT at one, two, three, and five years after insertion of the final prosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEEK group | Active comparator | Device: screw retained prosthesispatients receive all-on-4 prostheses constructed from CAD/CAM milled PEEK framework. |
| Soft metal group | Active comparator | Device: screw retained prosthesispatients receive all-on-4 prostheses constructed from CAD/CAM milled soft metal framework. |
| selective laser melting group | Active comparator | Device: screw retained prosthesispatients receive all-on-4 prostheses constructed from 3D printed selective laser melting Co-Cr framework. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Completely edentulous maxillary ridges and mandibular arch with four implants placed according to the All-on-4 distribution. All patients were recruited from the previous study.
- All selected patients will be with sufficient inter-arch space and restorative space.
- All selected patients will have healthy ridges covered by the compressible oral mucosa and free from any ridge flabbiness.
Key exclusion criteria (2 listed)
- History of para-functional habits (Bruxism, clenching), smoking, and alcoholism.
- History of radiation therapy in the head and neck region.
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 |
|---|---|---|
| screw retained prosthesisAlso: hybrid prosthsisall-on-4 screw-retained prosthesis. | Device | PEEK group, Soft metal group, selective laser melting group |
Primary outcome
bone changes
Time frame: 5 years
circumferential peri-implant bone changes in mm
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 11 Oct 2023.
- Derived from this study: PubMed 39112988Mourad KE, Rashed NHAH, Altonbary GY, Fattah Hegazy SA. Five years of radiographic evaluation for the peri-implant bone changes of all-on-four implant prostheses constructed from different framework materials using different digital construction techniques. BMC Oral Health. 2024 Aug 7;24(1):910. doi: 10.1186/s12903-024-04642-7.
- Individual participant dataSharing planned: No
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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.
Khloud Ezzat, PhD principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing screw retained prosthesis in people with Bone Loss, 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 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: finished, as of the sponsor's last update on 11 Oct 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?
bone changes (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06071689, which also lists 1 linked publication.
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 11 Oct 2023.