Dental ProsthesisNCT06114966
Titanium Versus Soft Metal CAD/CAM Frameworks for All-on-4 Implant Supported Prosthesis
A study testing CADCAM in people with Dental Prosthesis, run by Mansoura University at 1 site in Egypt.
Trial summary
This study is aimed to compare between titanium framework and soft metal framework used for mandibular All-on-4 implant supported prosthesis. The evaluation will be for: Peri-implant soft tissue health including; Plaque index, Probing depth and bleeding index. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Prosthesis
- What is being tested?
- CADCAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2023to 20 May 2025
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completely edentulous maxillary and mandibular ridges with sufficient mandibular bone height in the inter-foraminal area confirmed with panoramic x-rays.
- All selected patients will be with sufficient inter-arch space and restorative space.
- All selected patients will have apparently healthy ridge covered by compressible oral mucosa and free from any ridge flabbiness.
Who cannot join
- Patients with systemic diseases that contraindicate implant placement such as hematologic diseases, serious problems of coagulation and diseases of the immune system. Also, metabolic diseases related to bone resorption such as uncontrolled diabetics or osteoporosis will be also excluded
- 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.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University, Faculty of dentistry
Al Mansurah
Mohamed Shady, MD, 01005225707, Mohamedshady@mans.edu.eg
About this study
Official title: Titanium Versus Soft Metal CAD/CAM Frameworks for All-on-4 Implant Supported Prosthesis. A Study of Peri-implant Changes and Framework Adaptation
This study is aimed to compare between titanium framework and soft metal framework used for mandibular All-on-4 implant supported prosthesis.
The evaluation will be for:
Read more
- Peri-implant soft tissue health including; Plaque index, Probing depth and bleeding index.
- Bone level changes around implant using periapical x-ray after 6 months and 12 months and 18 months from insertion of fixed prosthesis.
- Framework adaptation of titanium framework and soft metal framework using surface matching software.
Patient grouping:
- 20 Patients will be classified into 2 equal groups, first group will receive 4 implants placed according to All on 4 concept supporting screw retained prosthesis with titanium framework manufactured by dry milling technique, second group will receive 4 implants placed according to All on 4 concept supporting screw retained prosthesis with metal framework manufactured by dry milling/post sintering of Co-Cr soft metal blocks.
The evaluation will be for:
- Bone level changes around implant using periapical x-ray after 6 months and 12 months and 18 months from insertion of fixed prosthesis.
Read the detailed description
This study will compare between titanium framework and soft metal framework used for mandibular All-on-4 implant supported prosthesis regarding bone level changes around implant using periapical x-ray after 6 months and 12 months and 18 months from insertion of fixed prosthesis.
Patient selection Twenty patients will be selected from the out-patient clinic of Prosthodontic Department, Faculty of Dentistry, Mansoura University seeking for prosthetic rehabilitation.
All patients will be informed about all surgical and prosthetic procedures that will be done. Also; they will sign the consent form of ethical committee of faculty of dentistry.
All implants will be installed in the edentulous mandible in each target positions according to their arrangements guided by stereolithographic stent.
- A cone beam computerized tomographic scan will be taken prior to surgery to determine the bone quality and bone volume and construct the surgical stent.
- Infiltration local anesthetic solution will be given for each patient.
- Each patient will receive 2 distally tilted implants in the posterior region anterior to mental foramen followed by 2 anterior implants.
- The stent will allow for optimal positioning, alignment, parallelism, and inclination of the implants for subsequent anchorage and prosthetic support.
- Once implant is placed, multiunit abutment will be placed. Hand tightens will take x-ray to verify seated properly. Torque to 15Ncm for tilted, 35Ncm for straight.
- Antibiotics (Augmentin 1g) will be given 1 hour before surgery and then daily for 5 days. Anti-inflammatory medication will be given after surgery if needed. Analgesics (brufen 600mg) will be given after surgery if needed.
- Immediate loading of the implants will be done by modifying the mandibular denture.
- 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 construction of the titanium and soft metal superstructures and the final prosthesis.
- Digital impression technique will be made using intraoral scanner and scan bodies and the resultant scan will be used in construction of titanium and soft metal superstructures with the abutments.
Patient grouping:
- Patients will be classified into 2 equal groups, first group will have titanium framework manufactured by dry milling technique, second group will have metal framework manufactured by dry milling/post sintering of Co-Cr soft metal blocks.
- The fit of the frameworks will be verified intraorally and the final fixed prosthesis will be constructed from PMMA for both groups.
The evaluation will be for:
- Bone level changes around implant using periapical x-ray after 6 months and 12 months and 18 months from insertion of fixed prosthesis.
- Conditions
- Dental Prosthesis
- Being tested
- CADCAM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CADCAMOther
Milling of Final prosthesis over dental implants using CADCAM milling machine
| Study group | Role | What they receive |
|---|---|---|
| titanium framework manufactured by dry milling technique | Experimental | All patients will have titanium framework manufactured by dry milling technique and occlusal material made from PMMA FPD Receives: Other: CADCAM |
| metal framework manufactured by dry milling/post sintering of Co-Cr soft metal blocks | Experimental | All patients will have metal framework manufactured by dry milling/post sintering of Co-Cr soft metal blocks and occlusal material made from PMMA FPD Receives: Other: CADCAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant crestal bone resorption
Crestal bone level will be evaluated by Periapical x-ray
Measured: at time of insertion of prosthesis procedure T(0), 6 months after insertion T(6), 12 months after insertion T(12), 18 months after insertion (T18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start20 Sep 2023
- Primary completion20 Apr 2025 (estimated)
- Study completion20 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ProsthesisStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed shady, Mansoura University
- Investigators
- Mohamed Shady, MD, Principal investigator, Mansoura University Faculty of Dentistry, Prosthodontics department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114966
- Sponsor's protocol ID
- A0109023
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Titanium Versus Soft Metal CAD/CAM Frameworks for All-on-4 Implant Supported Prosthesis. A Study of Peri-implant Changes and Framework Adaptation
- ClinicalTrials.gov ID
- NCT06114966
- Acronym / sponsor ID
- A0109023
- Conditions
- Dental Prosthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 20 Apr 2025 (estimated)
- Study completion
- 20 May 2025 (estimated)
- First posted
- 2 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 study is aimed to compare between titanium framework and soft metal framework used for mandibular All-on-4 implant supported prosthesis.
The evaluation will be for:
- Peri-implant soft tissue health including; Plaque index, Probing depth and bleeding index.
- Bone level changes around implant using periapical x-ray after 6 months and 12 months and 18 months from insertion of fixed prosthesis.
- Framework adaptation of titanium framework and soft metal framework using surface matching software.
Patient grouping:
- 20 Patients will be classified into 2 equal groups, first group will receive 4 implants placed according to All on 4 concept supporting screw retained prosthesis with titanium framework manufactured by dry milling technique, second group will receive 4 implants placed according to All on 4 concept supporting screw retained prosthesis with metal framework manufactured by dry milling/post sintering of Co-Cr soft metal blocks.
The evaluation will be for:
- Bone level changes around implant using periapical x-ray after 6 months and 12 months and 18 months from insertion of fixed prosthesis.
Detailed description
This study will compare between titanium framework and soft metal framework used for mandibular All-on-4 implant supported prosthesis regarding bone level changes around implant using periapical x-ray after 6 months and 12 months and 18 months from insertion of fixed prosthesis.
Patient selection Twenty patients will be selected from the out-patient clinic of Prosthodontic Department, Faculty of Dentistry, Mansoura University seeking for prosthetic rehabilitation.
All patients will be informed about all surgical and prosthetic procedures that will be done. Also; they will sign the consent form of ethical committee of faculty of dentistry.
All implants will be installed in the edentulous mandible in each target positions according to their arrangements guided by stereolithographic stent.
- A cone beam computerized tomographic scan will be taken prior to surgery to determine the bone quality and bone volume and construct the surgical stent.
- Infiltration local anesthetic solution will be given for each patient.
- Each patient will receive 2 distally tilted implants in the posterior region anterior to mental foramen followed by 2 anterior implants.
- The stent will allow for optimal positioning, alignment, parallelism, and inclination of the implants for subsequent anchorage and prosthetic support.
- Once implant is placed, multiunit abutment will be placed. Hand tightens will take x-ray to verify seated properly. Torque to 15Ncm for tilted, 35Ncm for straight.
- Antibiotics (Augmentin 1g) will be given 1 hour before surgery and then daily for 5 days. Anti-inflammatory medication will be given after surgery if needed. Analgesics (brufen 600mg) will be given after surgery if needed.
- Immediate loading of the implants will be done by modifying the mandibular denture.
- 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 construction of the titanium and soft metal superstructures and the final prosthesis.
- Digital impression technique will be made using intraoral scanner and scan bodies and the resultant scan will be used in construction of titanium and soft metal superstructures with the abutments.
Patient grouping:
- Patients will be classified into 2 equal groups, first group will have titanium framework manufactured by dry milling technique, second group will have metal framework manufactured by dry milling/post sintering of Co-Cr soft metal blocks.
- The fit of the frameworks will be verified intraorally and the final fixed prosthesis will be constructed from PMMA for both groups.
The evaluation will be for:
- Bone level changes around implant using periapical x-ray after 6 months and 12 months and 18 months from insertion of fixed prosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| titanium framework manufactured by dry milling technique | Experimental | Other: CADCAMAll patients will have titanium framework manufactured by dry milling technique and occlusal material made from PMMA FPD |
| metal framework manufactured by dry milling/post sintering of Co-Cr soft metal blocks | Experimental | Other: CADCAMAll patients will have metal framework manufactured by dry milling/post sintering of Co-Cr soft metal blocks and occlusal material made from PMMA FPD |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Completely edentulous maxillary and mandibular ridges with sufficient mandibular bone height in the inter-foraminal area confirmed with panoramic x-rays.
- All selected patients will be with sufficient inter-arch space and restorative space.
- All selected patients will have apparently healthy ridge covered by compressible oral mucosa and free from any ridge flabbiness.
Key exclusion criteria (3 listed)
- Patients with systemic diseases that contraindicate implant placement such as hematologic diseases, serious problems of coagulation and diseases of the immune system. Also, metabolic diseases related to bone resorption such as uncontrolled diabetics or osteoporosis will be also excluded
- 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 |
|---|---|---|
| CADCAMMilling of Final prosthesis over dental implants using CADCAM milling machine | Other | metal framework manufactured by dry milling/post sintering of Co-Cr soft metal blocks, titanium framework manufactured by dry milling technique |
Primary outcome
Peri-implant crestal bone resorption
Time frame: at time of insertion of prosthesis procedure T(0), 6 months after insertion T(6), 12 months after insertion T(12), 18 months after insertion (T18)
Crestal bone level will be evaluated by Periapical x-ray
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- 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.
Mohamed Shady, MD principal investigator
Mansoura University Faculty of Dentistry, Prosthodontics department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CADCAM in people with Dental Prosthesis, 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 3 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 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Shady, MD (01005225707, Mohamedshady@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant crestal bone resorption (time frame: at time of insertion of prosthesis procedure T(0), 6 months after insertion T(6), 12 months after insertion T(12), 18 months after insertion (T18)). 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 2 Nov 2023.