Allogenic Bone RingNCT03906591
Crestal Bone Level After Allogenic Bone Ring With Simultaneous Dental Implant Placement
A study testing allogenic bone ring and autogenous bone ring in people with Allogenic Bone Ring, run by Cairo University.
Trial summary
This trial is aiming to answer a question whether in Patients with severely atrophied, distal mandibular regions, the use of allogenic bone rings with simultaneous dental implants, compared to autogenous bone rings, give successful clinical and radiographic outcomes without donor site morbidity Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Allogenic Bone Ring
- What is being tested?
- allogenic bone ring and autogenous bone ring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Feb 2023
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically free form any systemic diseases that contraindicate the surgical procedures or affect predictable outcomes and non-smoker subjects.
- Atrophic mandibular distal region requiring vertical augmentation.
- Good oral hygiene and healthy keratinized mucosa.
Who cannot join
- Presence of acute dentoalveolar infection or any pathologic lesions.
- Totally edentulous patients and patients requiring massive reconstruction and augmentation procedures.
- Patients with history of previously failed augmentation procedures, or failed implant placement at the intended augmentation region.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation Of Crestal Bone Level After Alveolar Bone Augmentation of Atrophied Posterior Mandibular Region Using Allogenic Bone Rings Vs. Autogenous Bone Rings With Simultaneous Dental Implant Placement (A Randomized Controlled Clinical Trial)
This trial is aiming to answer a question whether in Patients with severely atrophied, distal mandibular regions, the use of allogenic bone rings with simultaneous dental implants, compared to autogenous bone rings, give successful clinical and radiographic outcomes without donor site morbidity
- Conditions
- Allogenic Bone Ring
- Being tested
- allogenic bone ring, autogenous bone ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogenic bone ringProcedure or surgery
allogenic bone ring with simultaneous dental implant placement
autogenous bone ringProcedure or surgery
autogenous bone ring with simultaneous dental implant placement
| Study group | Role | What they receive |
|---|---|---|
| allogenic bone ring | Experimental | Not described Receives: Procedure: allogenic bone ring |
| autogenous bone ring | Active comparator | Not described Receives: Procedure: autogenous bone ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in crestal bone height
cone beam computed tomography will be used to measure bone height in millimeters
Measured: at 6 months
Secondary outcomes (2)
graft failure
signs of graft failure will be evaluated by clinical examination
Measured: after 1 week, 6 months and after 9 months
implant loss
signs of implant loss will be evaluated by clinical examination
Measured: after 1 week, 6 months and after 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogenic Bone RingStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa El-Deen Ragab Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906591
- Sponsor's protocol ID
- allogenic bone ring
- Status last verified
- Apr 2019
- First submitted
- 4 Apr 2019
- Last updated
- 8 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Crestal Bone Level After Alveolar Bone Augmentation of Atrophied Posterior Mandibular Region Using Allogenic Bone Rings Vs. Autogenous Bone Rings With Simultaneous Dental Implant Placement (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT03906591
- Acronym / sponsor ID
- allogenic bone ring
- Conditions
- Allogenic Bone Ring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 8 Apr 2019 (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 trial is aiming to answer a question whether in Patients with severely atrophied, distal mandibular regions, the use of allogenic bone rings with simultaneous dental implants, compared to autogenous bone rings, give successful clinical and radiographic outcomes without donor site morbidity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| allogenic bone ring | Experimental | Procedure: allogenic bone ring |
| autogenous bone ring | Active comparator | Procedure: autogenous bone ring |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Medically free form any systemic diseases that contraindicate the surgical procedures or affect predictable outcomes and non-smoker subjects.
- Atrophic mandibular distal region requiring vertical augmentation.
- Good oral hygiene and healthy keratinized mucosa.
Key exclusion criteria (3 listed)
- Presence of acute dentoalveolar infection or any pathologic lesions.
- Totally edentulous patients and patients requiring massive reconstruction and augmentation procedures.
- Patients with history of previously failed augmentation procedures, or failed implant placement at the intended augmentation 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 |
|---|---|---|
| allogenic bone ringallogenic bone ring with simultaneous dental implant placement | Procedure or surgery | allogenic bone ring |
| autogenous bone ringautogenous bone ring with simultaneous dental implant placement | Procedure or surgery | autogenous bone ring |
Primary outcome
change in crestal bone height
Time frame: at 6 months
cone beam computed tomography will be used to measure bone height in millimeters
2 secondary outcomes
graft failure
Time frame: after 1 week, 6 months and after 9 months
implant loss
Time frame: after 1 week, 6 months and after 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
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.
Questions about this trial
What is this clinical trial studying?
A study testing allogenic bone ring and autogenous bone ring in people with Allogenic Bone Ring, run by Cairo University.
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 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 alaa ragab, master (00201224665688, dralaa3@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in crestal bone height (time frame: at 6 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 8 Apr 2019.