Implant AssesmentNCT07284680
Bio-implant Root Analogue Versus Conventional Screw-type Implant for Management of Pier Abutment in Mandibular Distal Extension Cases
A study testing Implant in people with Implant Assesment, run by Mansoura University at 1 site in Egypt.
Trial summary
reviewing literature was lacking for bio implant and management of pier abutment in distal extension bases for this reason the aim of this research will be to use the bio implant in the management of pier abutment cases for distal extension denture base cases Aim of the study the aim of this study was to evaluate and… Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Assesment
- What is being tested?
- Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Dec 2022to 30 Dec 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patients had bilateral mandibular free-end partially edentulous cases with a pier abutment or a planned presence of pier abutment.
- The edentulous space mesial to the pier abutment has a hopeless tooth or root that was used for bio-implant insertion or conventional screw-type implants.
- Healthy patients with no systemic disease that can affect the implant surgery. This was verified by medical history in addition to a report from the physician.
- The patients have had dentulous maxillary jaw and mandibular free-end saddle for at least 6 months.
- Class I maxillo-mandibular relationship with adequate inter-arch distance.
Who cannot join
- Patients with metabolic disorders that affect osseointegration such as uncontrolled diabetes mellitus, immune disorders, and osteoporosis.
- Patients with heavy smoking habit
- Patients complaining of severe temporomandibular joint disorder.
Trial locations and contacts
1 site in 1 country.
About this study
reviewing literature was lacking for bio implant and management of pier abutment in distal extension bases for this reason the aim of this research will be to use the bio implant in the management of pier abutment cases for distal extension denture base cases Aim of the study the aim of this study was to evaluate and compare the bioimplant root analogue implant with the conventional screw type implant the evaluation was done 0,3 and 6months of definitive prosthesis insertion regarding the following
- radiographic evaluation of the alveolar bone hight as related to the bio implant ,conventional screw implant , pier abutment and RPD abutments : this will be done using standardized periapical digital radiographs
- soft tissue evaluatins related to the bio implant ,conventional screw implant , pier abutment and RPD abutments this will be done using : A . modified plaque index (MPI) B . modified gingival index (MGI) C . peridontal pocket depth
- Conditions
- Implant Assesment
- Being tested
- Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplantDevice
construction of prothesis related to bioimplant or conventional implant
| Study group | Role | What they receive |
|---|---|---|
| bioimolant | Experimental | bioimplant assessement Receives: Device: Implant |
| screw type conventional implant | Experimental | conventional screw type implant assessement Receives: Device: Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone changes and soft tissue changes
peri-implant bone and soft tissue changes and abutment teeth bone and soft tissue changes changes periapical X-ray for measurement of bone changes by millimeter periodontal probe for measurement of soft tissue changes by millimeter
Measured: after 3 and 6 months of denture insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start19 Dec 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant AssesmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam eldin Hegazy Mohamed Ebrahim Eid, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284680
- Sponsor's protocol ID
- A11061222
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-implant Root Analogue Versus Conventional Screw-type Implant for Management of Pier Abutment in Mandibular Distal Extension Cases
- ClinicalTrials.gov ID
- NCT07284680
- Acronym / sponsor ID
- A11061222
- Conditions
- Implant Assesment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 16 Dec 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.
reviewing literature was lacking for bio implant and management of pier abutment in distal extension bases for this reason the aim of this research will be to use the bio implant in the management of pier abutment cases for distal extension denture base cases Aim of the study the aim of this study was to evaluate and compare the bioimplant root analogue implant with the conventional screw type implant the evaluation was done 0,3 and 6months of definitive prosthesis insertion regarding the following
- radiographic evaluation of the alveolar bone hight as related to the bio implant ,conventional screw implant , pier abutment and RPD abutments : this will be done using standardized periapical digital radiographs
- soft tissue evaluatins related to the bio implant ,conventional screw implant , pier abutment and RPD abutments this will be done using : A . modified plaque index (MPI) B . modified gingival index (MGI) C . peridontal pocket depth
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bioimolant | Experimental | Device: Implantbioimplant assessement |
| screw type conventional implant | Experimental | Device: Implantconventional screw type implant assessement |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patients had bilateral mandibular free-end partially edentulous cases with a pier abutment or a planned presence of pier abutment.
- The edentulous space mesial to the pier abutment has a hopeless tooth or root that was used for bio-implant insertion or conventional screw-type implants.
- Healthy patients with no systemic disease that can affect the implant surgery. This was verified by medical history in addition to a report from the physician.
- The patients have had dentulous maxillary jaw and mandibular free-end saddle for at least 6 months.
- Class I maxillo-mandibular relationship with adequate inter-arch distance.
Key exclusion criteria (3 listed)
- Patients with metabolic disorders that affect osseointegration such as uncontrolled diabetes mellitus, immune disorders, and osteoporosis.
- Patients with heavy smoking habit
- Patients complaining of severe temporomandibular joint disorder.
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 |
|---|---|---|
| Implantconstruction of prothesis related to bioimplant or conventional implant | Device | bioimolant, screw type conventional implant |
Primary outcome
bone changes and soft tissue changes
Time frame: after 3 and 6 months of denture insertion
peri-implant bone and soft tissue changes and abutment teeth bone and soft tissue changes changes periapical X-ray for measurement of bone changes by millimeter periodontal probe for measurement of soft tissue changes by millimeter
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 16 Dec 2025.
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Fully Versus Partially Guided Implants Placement: Measurement of Accuracy of Implant Position and Passivity of Superstructures.
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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.
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 Implant in people with Implant Assesment, 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 5 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: under way, not looking for participants, as of the sponsor's last update on 16 Dec 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?
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 and soft tissue changes (time frame: after 3 and 6 months of denture insertion). 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 16 Dec 2025.