Marginal Bone LossRCTNCT06790524
Comparative Evaluation Between One-piece and Two-piece Implants Supporting Mandibular Screw-retained All-On-Four Full-arch Prosthesis on Peri-implant Bone Changes.
A study testing One-piece dental implants with MUA and Two-piece dental implants in people with Marginal Bone Loss and One-piece Implants Versus Two-piece Implants During the Osseointegration Phase, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluating the bone changing after receiving one-piece implants supported full arch prosthesis compared to the conventional two-piece implants. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Marginal Bone Loss, One-piece Implants Versus Two-piece Implants During the Osseointegration Phase
- What is being tested?
- One-piece dental implants with MUA and Two-piece dental implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2025to Oct 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completely edentulous patients, who can sign an informed consent will be considered eligible for this trial.
- Residual bone height should have sufficient volume and quality for implant placement with a minimum of 12-14 mm in height and 6 mm in width.
- Patients who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, technical problems concerning denture design and/or occlusion are found, or who are dissatisfied with the retention and stability of their technically satisfactory mandibular dentures.
Who cannot join
- - Patients with conditions that may contraindicate implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino bisphosphonates, patients undergoing radiotherapy to the head and neck region).
- Inadequate mouth opening
- Heavy smokers, more than 10 cigarettes/day
- Patients with poor oral hygiene and motivation.
- Pregnancy or nursing.
- Drug abusers.
- Psychiatric problems or unrealistic expectations.
- Patients with infection and or inflammation in the area intended for implant placement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Peri-implant Bone Changes Around One-piece Implant and Two-piece Implants Supporting Mandibular Screw-retained All-On-Four Full Arch Prosthesis: a Randomized Controlled Clinical Trial
Evaluating the bone changing after receiving one-piece implants supported full arch prosthesis compared to the conventional two-piece implants.
Read the detailed description
Studying the difference between one-piece and two-piece implants and their effect on bone loss. This will help in simplifying the surgical procedure for full arch implant-supported prosthesis rehabilitation using one-piece implants, eliminating the disturbance of the gum tissue around the implants, potentially reducing the risk of bacterial colonization and inflammation.
- Conditions
- Marginal Bone Loss, One-piece Implants Versus Two-piece Implants During the Osseointegration Phase
- Being tested
- One-piece dental implants with MUA, Two-piece dental implants
- Keywords
- one-piece implants , All-On-Four, Marginal bone loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-piece dental implants with MUADevice
Also called single piece implants, mono implenats
one-piece dental implants with multi-units abutment mounted on the implants as a single piece provided with different abutment angulation utilizing these implants for All-On-Four prothesis
Two-piece dental implantsDevice
Also called endosteal implants, root form implants
Surgical and immediate loading procedures:
On the day of implant placement, patients will receive two-piece implant. After crestal incision and full-thickness flap elevation, the implant sites will be prepared aided by a surgical template. 4 implants will be placed, two aligned in an axial orientation and two will be distally aligned (17 degrees). The standard placement procedure as recommended by the manufacturer will be used. The surgical drills with increasing diameters will be used to prepare the implant sites. Implants will be ideally placed at bone level (or 1 mm deeper depending on the soft tissue thickness). After 3 months as a healing phase, a definitive prosthesis will be fabricated using the same abutments, and the marginal bone loss after the osseointegration phase will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Patients will receive an implant screw-retained restoration supported by One-piece implants. | Experimental | One-piece dental implants with multi-unit abutments mounted on them, provided with different implant-abutment angulation which makes them utilizable for All-On-Four prosthesis. Receives: Device: One-piece dental implants with MUA |
| Patients will receive an implant screw-retained restoration supported by two-piece implants. | Active comparator | Two-piece Implants, Implant fixtures, and separate pieces of Multi-unit abutments with different angulations will be used to support the All-On-Four prostheiss. Receives: Device: Two-piece dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant marginal bone loss
Peri-implant marginal bone loss will be assessed utilizing CBCT. The radiographic evaluation will be performed at baseline and at 3 months after functional loading. Using the first thread of the implant as a standard reference point, the circumference of the Crestal bone level around the implant will be measured in all directions (mesial, distal, buccal, and lingual) in width and height.
Measured: From implant placement (baseline) and After 3 months (after the osseointegration phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study startMar 2025 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Bone LossStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Khaled Hassan Mahdy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790524
- Sponsor's protocol ID
- one-piece implants
- Acronym
- RCT
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2025
- Last updated
- 7 Mar 2025
- 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 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peri-implant Bone Changes Around One-piece Implant and Two-piece Implants Supporting Mandibular Screw-retained All-On-Four Full Arch Prosthesis: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06790524
- Acronym / sponsor ID
- RCT / one-piece implants
- Conditions
- Marginal Bone Loss, One-piece Implants Versus Two-piece Implants During the Osseointegration Phase
- Keywords
- one-piece implants , All-On-Four, Marginal bone loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 24 Jan 2025 (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.
Evaluating the bone changing after receiving one-piece implants supported full arch prosthesis compared to the conventional two-piece implants.
Detailed description
Studying the difference between one-piece and two-piece implants and their effect on bone loss. This will help in simplifying the surgical procedure for full arch implant-supported prosthesis rehabilitation using one-piece implants, eliminating the disturbance of the gum tissue around the implants, potentially reducing the risk of bacterial colonization and inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients will receive an implant screw-retained restoration supported by One-piece implants. | Experimental | Device: One-piece dental implants with MUAOne-piece dental implants with multi-unit abutments mounted on them, provided with different implant-abutment angulation which makes them utilizable for All-On-Four prosthesis. |
| Patients will receive an implant screw-retained restoration supported by two-piece implants. | Active comparator | Device: Two-piece dental implantsTwo-piece Implants, Implant fixtures, and separate pieces of Multi-unit abutments with different angulations will be used to support the All-On-Four prostheiss. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Completely edentulous patients, who can sign an informed consent will be considered eligible for this trial.
- Residual bone height should have sufficient volume and quality for implant placement with a minimum of 12-14 mm in height and 6 mm in width.
- Patients who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, technical problems concerning denture design and/or occlusion are found, or who are dissatisfied with the retention and stability of their technically satisfactory mandibular dentures.
Key exclusion criteria (8 listed)
- - Patients with conditions that may contraindicate implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino bisphosphonates, patients undergoing radiotherapy to the head and neck region).
- Inadequate mouth opening
- Heavy smokers, more than 10 cigarettes/day
- Patients with poor oral hygiene and motivation.
- Pregnancy or nursing.
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 |
|---|---|---|
| One-piece dental implants with MUAAlso: single piece implants, mono implenatsone-piece dental implants with multi-units abutment mounted on the implants as a single piece provided with different abutment angulation utilizing these implants for All-On-Four prothesis | Device | Patients will receive an implant screw-retained restoration supported by One-piece implants. |
| Two-piece dental implantsAlso: endosteal implants, root form implantsSurgical and immediate loading procedures: On the day of implant placement, patients will receive two-piece implant. After crestal incision and full-thickness flap elevation, the implant sites will be prepared aided by a surgical template. 4 implants will be placed, two aligned in an axial orientation and two will be distally aligned (17 degrees). The standard placement procedure as recommended by the manufacturer will be used. The surgical drills with increasing diameters will be used to prepare the implant sites. Implants will be ideally placed at bone level (or 1 mm deeper depending on the soft tissue thickness). After 3 months as a healing phase, a definitive prosthesis will be fabricated using the same abutments, and the marginal bone loss after the osseointegration phase will be assessed. | Device | Patients will receive an implant screw-retained restoration supported by two-piece implants. |
Primary outcome
Peri-implant marginal bone loss
Time frame: From implant placement (baseline) and After 3 months (after the osseointegration phase)
Peri-implant marginal bone loss will be assessed utilizing CBCT. The radiographic evaluation will be performed at baseline and at 3 months after functional loading. Using the first thread of the implant as a standard reference point, the circumference of the Crestal bone level around the implant will be measured in all directions (mesial, distal, buccal, and lingual) in width and height.
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 7 Mar 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-piece dental implants with MUA and Two-piece dental implants in people with Marginal Bone Loss and One-piece Implants Versus Two-piece Implants During the Osseointegration Phase, run by Cairo 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 8 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: opening soon, as of the sponsor's last update on 7 Mar 2025. 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?
Contact Esraa kh Mahdy (+201128616565, esraa.hassen@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant marginal bone loss (time frame: From implant placement (baseline) and After 3 months (after the osseointegration phase)). 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 7 Mar 2025.