Complete EdentulismNCT07812363
Titanium Versus Nano-Carbon CAD/CAM Frameworks for All-on-4 Implant Supported Hybrid Prosthesis.
A study testing Titanium CAD/CAM Framework and Nano-Carbon CAD/CAM Framework in people with Complete Edentulism, run by Mansoura University at 1 site in Egypt.
Trial summary
This clinical study compares two CAD/CAM framework materials, titanium and nano-carbon fiber-reinforced composite, used in mandibular All-on-4 implant-supported hybrid prostheses. Patients are randomly allocated into two equal groups, with 10 patients in each group. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- Titanium CAD/CAM Framework and Nano-Carbon CAD/CAM Framework
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 6 May 2024to Feb 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- * Completely edentulous patients requiring mandibular implant-supported rehabilitation.
- Adequate bone quantity and quality in the mandibular interforaminal region for implant placement.
- Adequate restorative space for an implant-supported hybrid prosthesis.
- Healthy oral mucosa and acceptable oral hygiene.
- Patients medically fit to undergo implant surgery.
- Ability and willingness to attend the scheduled follow-up visits and provide informed consent.
Who cannot join
- Systemic conditions or medical contraindications that could interfere with implant surgery or healing.
- History of radiotherapy to the head and neck region.
- Smoking.
- Alcohol abuse.
- Bruxism or clenching habits.
- Any local condition that could compromise implant placement or the planned prosthetic rehabilitation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate
About this study
Official title: Titanium Versus Nano-Carbon CAD/CAM Frameworks for All-on-4 Implant Supported Hybrid Prosthesis. A Study of Peri-implant Tissue Changes and Prosthetic Complications
This clinical study compares two CAD/CAM framework materials, titanium and nano-carbon fiber-reinforced composite, used in mandibular All-on-4 implant-supported hybrid prostheses. Patients are randomly allocated into two equal groups, with 10 patients in each group. The study evaluates peri-implant soft tissue health, changes in marginal bone levels, and prosthetic complications overa12-month follow-up period.
Read the detailed description
Completely edentulous patients receive four mandibular implants according to the All-on-4 concept, with two anterior axial implants and two posterior tilted implants placed anterior to the mental foramina. Patients are randomly allocated to receive either a CAD/CAM-milled titanium framework or a nano-carbon fiber-reinforced framework. Clinical follow-up includes assessment of modified plaque index, modified gingival index, probing depth, and bleeding index. Marginal bone level changes are assessed radiographically at 6 and 12 months after insertion of the fixed prosthesis. Prosthetic complications are also evaluated.
- Conditions
- Complete Edentulism
- Being tested
- Titanium CAD/CAM Framework, Nano-Carbon CAD/CAM Framework
- Keywords
- all-on-4, implant supported prosthesis, titanium framework, Nano-Carbon framework, CAD/CAM, peri-implant tissue, prosthetic complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium CAD/CAM FrameworkDevice
CAD/CAM-milled titanium framework used for mandibular All-on-4 implant-supported hybrid prosthesis.
Nano-Carbon CAD/CAM FrameworkDevice
Nano-carbon fiber-reinforced CAD/CAM framework used for mandibular All-on-4 implant-supported hybrid prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Titanium Framework Group | Active comparator | Participants received mandibular All-on-4 implant-supported hybrid prostheses fabricated with a CAD/CAM-milled titanium framework. Receives: Device: Titanium CAD/CAM Framework |
| Nano-Carbon Framework Group | Experimental | Participants received mandibular All-on-4 implant-supported hybrid prostheses fabricated with a Nano-carbon fiber-reinforced CAD/CAM framework. Receives: Device: Nano-Carbon CAD/CAM Framework |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone level change
Radiographic assessment of changes in peri-implant marginal bone level around the implants in the titanium and nano-carbon framework groups.
Measured: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
Secondary outcomes (5)
Modified plaque index
Assessment of plaque accumulation around the implants using the modified plaque index
Measured: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
Modified gingival index
Assessment of peri-implant gingival tissue condition using the modified gingival index
Measured: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
Probing depth
Measure of per-implant probing depth around the implants
Measured: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
Bleeding index
Assessment of peri-implant bleeding using the bleeding index
Measured: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
prosthetic complications
Assessment of prosthetic complications and maintenance requirements associated with the implant supported prosthesis
Measured: up to12 months after prosthesis insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start6 May 2024
- Primary completion10 Aug 2026
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Farouk Abdelwahed Saleh, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812363
- Sponsor's protocol ID
- A0102024RP
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared because the study was conducted as part of an academic doctoral research project and no data-sharing plan was established in the approved protocol.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Titanium Versus Nano-Carbon CAD/CAM Frameworks for All-on-4 Implant Supported Hybrid Prosthesis. A Study of Peri-implant Tissue Changes and Prosthetic Complications
- ClinicalTrials.gov ID
- NCT07812363
- Acronym / sponsor ID
- A0102024RP
- Conditions
- Complete Edentulism
- Keywords
- all-on-4, implant supported prosthesis, titanium framework, Nano-Carbon framework, CAD/CAM, peri-implant tissue, prosthetic complications
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 10 Sep 2026 (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 clinical study compares two CAD/CAM framework materials, titanium and nano-carbon fiber-reinforced composite, used in mandibular All-on-4 implant-supported hybrid prostheses. Patients are randomly allocated into two equal groups, with 10 patients in each group. The study evaluates peri-implant soft tissue health, changes in marginal bone levels, and prosthetic complications overa12-month follow-up period.
Detailed description
Completely edentulous patients receive four mandibular implants according to the All-on-4 concept, with two anterior axial implants and two posterior tilted implants placed anterior to the mental foramina. Patients are randomly allocated to receive either a CAD/CAM-milled titanium framework or a nano-carbon fiber-reinforced framework. Clinical follow-up includes assessment of modified plaque index, modified gingival index, probing depth, and bleeding index. Marginal bone level changes are assessed radiographically at 6 and 12 months after insertion of the fixed prosthesis. Prosthetic complications are also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titanium Framework Group | Active comparator | Device: Titanium CAD/CAM FrameworkParticipants received mandibular All-on-4 implant-supported hybrid prostheses fabricated with a CAD/CAM-milled titanium framework. |
| Nano-Carbon Framework Group | Experimental | Device: Nano-Carbon CAD/CAM FrameworkParticipants received mandibular All-on-4 implant-supported hybrid prostheses fabricated with a Nano-carbon fiber-reinforced CAD/CAM framework. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- * Completely edentulous patients requiring mandibular implant-supported rehabilitation.
Key exclusion criteria (6 listed)
- Systemic conditions or medical contraindications that could interfere with implant surgery or healing.
- History of radiotherapy to the head and neck region.
- Smoking.
- Alcohol abuse.
- Bruxism or clenching habits.
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 |
|---|---|---|
| Titanium CAD/CAM FrameworkCAD/CAM-milled titanium framework used for mandibular All-on-4 implant-supported hybrid prosthesis. | Device | Titanium Framework Group |
| Nano-Carbon CAD/CAM FrameworkNano-carbon fiber-reinforced CAD/CAM framework used for mandibular All-on-4 implant-supported hybrid prosthesis. | Device | Nano-Carbon Framework Group |
Primary outcome
Marginal bone level change
Time frame: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
Radiographic assessment of changes in peri-implant marginal bone level around the implants in the titanium and nano-carbon framework groups.
5 secondary outcomes
Modified plaque index
Time frame: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
Modified gingival index
Time frame: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
Probing depth
Time frame: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
Bleeding index
Time frame: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
prosthetic complications
Time frame: up to12 months after prosthesis insertion
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 30 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared because the study was conducted as part of an academic doctoral research project and no data-sharing plan was established in the approved protocol.
Related trials for Complete Edentulism
Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
Edentulism
Recruiting
Accuracy of Complete-Arch Implant Scans Using Non Calibrated Splinting Scanbodies
Edentulism Complete
Not yet recruiting
Comparison of Open-Mouth and Closed-Mouth Impression Techniques for Complete Dentures
Edentulism
Recruiting
Nutritional Intervention for Older Adults With Complete Dentures
Edentulism Complete, Denture, Complete
Recruiting
Microbial Adhesion and Peri-Implant Tissue Health in All-on-Four Hybrid Prostheses Supported by Zantex or Zirconia Frameworks
Complete Edentulism
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 Titanium CAD/CAM Framework and Nano-Carbon CAD/CAM Framework in people with Complete Edentulism, 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 6 inclusion and 6 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 30 Sep 2026. 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?
Marginal bone level change (time frame: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)). 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 30 Sep 2026.