Edentulous MandibleCSDSMDANCT06673355
"Comparative Study of Supra-Structure Materials in Full-Arch Implant Prosthetics: a Randomized Clinical Trial"
A study testing dental implant prosthesis in people with Edentulous Mandible, run by Misr University for Science and Technology at 1 site in Egypt.
Trial summary
after the implants' osseointegration period (4 months), digital scans will be taken for the implant positions and the STL files will be stored and sent for the CAD software to design a full arch restoration. Read more about this study
- Who is it for?
- Ages 25 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Edentulous Mandible
- What is being tested?
- dental implant prosthesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jul 2024to 8 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-smokers
- patients with adequate bone height and width
- patients with good oral hygiene and healthy gingiva
Who cannot join
- smokers
- patients with inadequate bone height and width
- non-compliant patients
- patients with systemic diseases that will affect bone remodelling
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Misr University for Science and Technology
Giza, Giza Governorate, 12573
About this study
Official title: Comparative Study of Different Supra-structure Materials in Digitally Designed Full-arch Implant-supported Prosthesis. (Bone Changes and Teeth Wear Analysis) - a Randomized Clinical Trial
after the implants' osseointegration period (4 months), digital scans will be taken for the implant positions and the STL files will be stored and sent for the CAD software to design a full arch restoration. Two types will be constructed, Group I patients will receive porcelain fused to titanium frameworks, and Group II will receive a framework made of high-performance polymer filled with nano-zirconia and carbon. After the installation of the frameworks, the bone height changes and the wear of the occlusal surfaces will be monitored at baseline, after 6 months and 12 months post insertion.
Read the detailed description
After the implants' osseointegration period of four months, a series of steps will be undertaken to ensure the precise design and implementation of the full-arch restorations.
First, digital scans of the implant positions will be conducted using advanced scanning technology. These scans will accurately capture the spatial orientation and positioning of the implants within the jaw. The resulting STL (Standard Tessellation Language) files, which represent the 3D geometry of the scanned implants, will be securely stored and transmitted to computer-aided design (CAD) software. This software will facilitate the design process for the full-arch restorations.
In this study, two distinct types of full-arch frameworks will be constructed for the participants, who will be divided into two groups based on the material used.
- Group I will receive frameworks made of porcelain fused to titanium (P/FtTi). This material is known for its strength, durability, and aesthetic qualities, providing a reliable option for prosthetic restorations.
- Group II will receive frameworks crafted from a high-performance polymer enhanced with nano-zirconia and carbon fillers. This innovative material is designed to offer superior mechanical properties, including increased strength and reduced wear while being lightweight and biocompatible.
Once the frameworks are installed in the patient's mouth, the study will focus on monitoring the changes in bone height and the wear of the occlusal surfaces over time. Measurements will be taken at three key intervals: baseline ( time of framework fixation), and then again at six months and twelve months post-insertion.
This monitoring will involve radiographic assessments using CBCT and clinical evaluations to quantify any bone resorption around the implants and to assess the wear patterns of the occlusal surfaces using the intraoral scanner, the STL files of the scans will be superimposed on a software (Geomagic) that is used to measure changes and deviations between the scans. The data collected will provide valuable insights into the long-term performance and stability of the different materials used in the full-arch restorations, thereby contributing to the understanding of their clinical efficacy in implant-supported prosthetics.
- Conditions
- Edentulous Mandible
- Being tested
- dental implant prosthesis
- Keywords
- all on 4 full arch restorations in the mandible
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implant prosthesisOther
patients will receive frameworks made of high-performance polymer filled with nano zirconia and carbon
| Study group | Role | What they receive |
|---|---|---|
| patients will receive frameworks made of high-performance polymer | Experimental | patients will receive frameworks made of high-performance polymer filled with nano zirconia and carbon, the framework will be digitally produced by the milling technology using a dental CNC machine. the bone changes and occlusal wear will be assessed at the time of insertion (as a baseline), after 6 months and after 12 months. Receives: Other: dental implant prosthesis |
| patients will receive frameworks made of porcelain fused to titanium | Active comparator | patients will receive frameworks made of porcelain fused to titanium, the titanium will be produced digitally by 3d printing using the selective laser melting technology. Bone changes and wear of occlusal surfaces will be assessed at time of insertion (baseline, after 6 months and after 12 months Receives: Other: dental implant prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone height changes around the implants
bone height changes around the implants will be assessed using CBCT. this will be acquired at the time of insertion, after 6 months and after 12 months. bone height changes will be measured at the buccal, mesial, distal and lingual surfaces around each implant.
Measured: 12 months
Secondary outcomes (1)
occlusal surface wear analysis
occlusal surface wear analysis will be performed by taking intraoral scans and saving the scan (STL) files to be imported into a specific software that is used to compare and measure the deviations between the reference file and the new files. the scans will be taken at the time of framework insertion, after 6 months and after 12 months post-insertion.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start8 Jul 2024
- Primary completion8 Aug 2025 (estimated)
- Study completion8 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous MandibleStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HEBA ELSARRIF, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673355
- Sponsor's protocol ID
- RECO6U/2024
- Acronym
- CSDSMDA
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD collected throughout the trial, only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Different Supra-structure Materials in Digitally Designed Full-arch Implant-supported Prosthesis. (Bone Changes and Teeth Wear Analysis) - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06673355
- Acronym / sponsor ID
- CSDSMDA / RECO6U/2024
- Conditions
- Edentulous Mandible
- Keywords
- all on 4 full arch restorations in the mandible
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 8 Aug 2025 (estimated)
- Study completion
- 8 Aug 2025 (estimated)
- First posted
- 4 Nov 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.
after the implants' osseointegration period (4 months), digital scans will be taken for the implant positions and the STL files will be stored and sent for the CAD software to design a full arch restoration. Two types will be constructed, Group I patients will receive porcelain fused to titanium frameworks, and Group II will receive a framework made of high-performance polymer filled with nano-zirconia and carbon. After the installation of the frameworks, the bone height changes and the wear of the occlusal surfaces will be monitored at baseline, after 6 months and 12 months post insertion.
Detailed description
After the implants' osseointegration period of four months, a series of steps will be undertaken to ensure the precise design and implementation of the full-arch restorations.
First, digital scans of the implant positions will be conducted using advanced scanning technology. These scans will accurately capture the spatial orientation and positioning of the implants within the jaw. The resulting STL (Standard Tessellation Language) files, which represent the 3D geometry of the scanned implants, will be securely stored and transmitted to computer-aided design (CAD) software. This software will facilitate the design process for the full-arch restorations.
In this study, two distinct types of full-arch frameworks will be constructed for the participants, who will be divided into two groups based on the material used.
- Group I will receive frameworks made of porcelain fused to titanium (P/FtTi). This material is known for its strength, durability, and aesthetic qualities, providing a reliable option for prosthetic restorations.
- Group II will receive frameworks crafted from a high-performance polymer enhanced with nano-zirconia and carbon fillers. This innovative material is designed to offer superior mechanical properties, including increased strength and reduced wear while being lightweight and biocompatible.
Once the frameworks are installed in the patient's mouth, the study will focus on monitoring the changes in bone height and the wear of the occlusal surfaces over time. Measurements will be taken at three key intervals: baseline ( time of framework fixation), and then again at six months and twelve months post-insertion.
This monitoring will involve radiographic assessments using CBCT and clinical evaluations to quantify any bone resorption around the implants and to assess the wear patterns of the occlusal surfaces using the intraoral scanner, the STL files of the scans will be superimposed on a software (Geomagic) that is used to measure changes and deviations between the scans. The data collected will provide valuable insights into the long-term performance and stability of the different materials used in the full-arch restorations, thereby contributing to the understanding of their clinical efficacy in implant-supported prosthetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients will receive frameworks made of high-performance polymer | Experimental | Other: dental implant prosthesispatients will receive frameworks made of high-performance polymer filled with nano zirconia and carbon, the framework will be digitally produced by the milling technology using a dental CNC machine. the bone changes and occlusal wear will be assessed at the time of insertion (as a baseline), after 6 months and after 12 months. |
| patients will receive frameworks made of porcelain fused to titanium | Active comparator | Other: dental implant prosthesispatients will receive frameworks made of porcelain fused to titanium, the titanium will be produced digitally by 3d printing using the selective laser melting technology. Bone changes and wear of occlusal surfaces will be assessed at time of insertion (baseline, after 6 months and after 12 months |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- non-smokers
- patients with adequate bone height and width
- patients with good oral hygiene and healthy gingiva
Key exclusion criteria (4 listed)
- smokers
- patients with inadequate bone height and width
- non-compliant patients
- patients with systemic diseases that will affect bone remodelling
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 |
|---|---|---|
| dental implant prosthesispatients will receive frameworks made of high-performance polymer filled with nano zirconia and carbon | Other | patients will receive frameworks made of high-performance polymer, patients will receive frameworks made of porcelain fused to titanium |
Primary outcome
bone height changes around the implants
Time frame: 12 months
bone height changes around the implants will be assessed using CBCT. this will be acquired at the time of insertion, after 6 months and after 12 months. bone height changes will be measured at the buccal, mesial, distal and lingual surfaces around each implant.
1 secondary outcome
occlusal surface wear analysis
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: Yes. all IPD collected throughout the trial, only IPD used in the results publication
Related trials for Edentulous Mandible
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
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Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
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Comparison Between Neutral Zone and Admixed Impression Techniques for Atrophic Mandibular Ridges
Atrophic Mandibular Ridge in Edentulous Patients
Not yet recruiting
Clinical and Radiographic Comparison of Two Implant-Abutment Connections
Dental Implant, Edentulous Alveolar Ridge
Not yet recruiting
Trueness of Intra-Oral Scanners Compared to an Extra-Oral Scanner for Scanning of Mandibular Edentulous Impressions
Edentulous Jaw
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 dental implant prosthesis in people with Edentulous Mandible, run by Misr University for Science and Technology 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 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?
This study is still under way. Results are not available in the source record yet.
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 height changes around the implants (time frame: 12 months). 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 4 Nov 2024.