Ridge AugmentationNCT05620459
Anterior Maxilla Augmentation Using Chin Bone Ring With Implant Placement
A study testing Ridge augmentation using chin bone ring with simultaneous implant placement in people with Ridge Augmentation, run by Cairo University at 1 site in Egypt.
Trial summary
The study aims toward using autogenous bone grafts to solve decreased bone quantity in anterior maxilla while allowing the patient to recieve implants simultaneously (same time of grafting). Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ridge Augmentation
- What is being tested?
- Ridge augmentation using chin bone ring with simultaneous implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to Dec 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with non-restorable teeth in the maxillary anterior region with insufficient buccal bone height or buccal bone defect.
- Patients who have given their consent for this trial.
- Both genders males and females will be included.
Who cannot join
- • Untreated periodontitis.
- Poor oral hygiene and motivation.
- Uncontrolled diabetes.
- Pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
cairo University
Cairo, cairo/Manial, 11553
cairo university
About this study
Official title: Computer Guided Simultaneous Implant Placement With Ridge Augmentation Using Autogenous Bone Ring Transplant in Defective Maxillary Anterior Sockets
The study aims toward using autogenous bone grafts to solve decreased bone quantity in anterior maxilla while allowing the patient to recieve implants simultaneously (same time of grafting).
Read the detailed description
- Chin bone ring will be harvested from patient's(10 in number) chin to augment the recent extraction socket with buccal bone defect, followed by implant placement.
- The process of harvesting and placement of ring will be computer guided which adds lots of accuracy to the bone ring required size from the donor site and the proper placement of both the ring and the implant at the recipient site
- Conditions
- Ridge Augmentation
- Being tested
- Ridge augmentation using chin bone ring with simultaneous implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ridge augmentation using chin bone ring with simultaneous implant placementProcedure or surgery
surgical guides are to be used to harvest chin bone ring, the rings are to be used for bone augmentation in extraction sockets (salama and salama classsification type II),simultaneously implant placement.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm (Ridge augmentation with simultaneous implant placement) | Experimental | Chin bone ring is harvested using surgical guide to augment
1. anterior maxillary defective recent extraction sockets OR
2. remaining roots that need extraction and are accompanied with labial bone loss Associated with simultaneous implant placement with the aid of surgical guides Receives: Procedure: Ridge augmentation using chin bone ring with simultaneous implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone quantity (crestal bone) height)
Cone beam
Measured: 3 months after operation day
Secondary outcomes (1)
Bone quality (bone density at the ring alveolus interface)
In Hounsfield units making use of ROI region of intrest tool included in the software
Measured: 3 months after operation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Oct 2022
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ridge AugmentationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohamed Gad Mohamed Gad, Cairo University
- Investigators
- Mostafa M gad, bds, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620459
- Sponsor's protocol ID
- 10722
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yuce MO, Adali E, Turk G, Isik G, Gunbay T. Three-dimensional bone grafting in dental implantology using autogenous bone ring transplant: Clinical outcomes of a one-stage technique. Niger J Clin Pract. 2019 Jul;22(7):977-981. doi: 10.4103/njcp.njcp_652_18.
PubMed 31293264Omara M, Abdelwahed N, Ahmed M, Hindy M. Simultaneous implant placement with ridge augmentation using an autogenous bone ring transplant. Int J Oral Maxillofac Surg. 2016 Apr;45(4):535-44. doi: 10.1016/j.ijom.2015.11.001. Epub 2015 Nov 28.
PubMed 26644216Simpson KT, Bryington M, Agusto M, Harper M, Salman A, Schincaglia GP. Computer-Guided Surgery Using Human Allogenic Bone Ring With Simultaneous Implant Placement: A Case Report. Clin Adv Periodontics. 2020 Mar;10(1):16-22. doi: 10.1002/cap.10073. Epub 2019 Oct 14.
PubMed 31513341Stevens MR, Emam HA, Alaily ME, Sharawy M. Implant bone rings. One-stage three-dimensional bone transplant technique: a case report. J Oral Implantol. 2010;36(1):69-74. doi: 10.1563/AAID-JOI-D-09-00029.
PubMed 20218871
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Guided Simultaneous Implant Placement With Ridge Augmentation Using Autogenous Bone Ring Transplant in Defective Maxillary Anterior Sockets
- ClinicalTrials.gov ID
- NCT05620459
- Acronym / sponsor ID
- 10722
- Conditions
- Ridge Augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Nov 2022 (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.
The study aims toward using autogenous bone grafts to solve decreased bone quantity in anterior maxilla while allowing the patient to recieve implants simultaneously (same time of grafting).
Detailed description
- Chin bone ring will be harvested from patient's(10 in number) chin to augment the recent extraction socket with buccal bone defect, followed by implant placement.
- The process of harvesting and placement of ring will be computer guided which adds lots of accuracy to the bone ring required size from the donor site and the proper placement of both the ring and the implant at the recipient site
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm (Ridge augmentation with simultaneous implant placement) | Experimental | Procedure: Ridge augmentation using chin bone ring with simultaneous implant placementChin bone ring is harvested using surgical guide to augment 1. anterior maxillary defective recent extraction sockets OR 2. remaining roots that need extraction and are accompanied with labial bone loss Associated with simultaneous implant placement with the aid of surgical guides |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with non-restorable teeth in the maxillary anterior region with insufficient buccal bone height or buccal bone defect.
- Patients who have given their consent for this trial.
- Both genders males and females will be included.
Key exclusion criteria (4 listed)
- • Untreated periodontitis.
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 |
|---|---|---|
| Ridge augmentation using chin bone ring with simultaneous implant placementsurgical guides are to be used to harvest chin bone ring, the rings are to be used for bone augmentation in extraction sockets (salama and salama classsification type II),simultaneously implant placement. | Procedure or surgery | Interventional arm (Ridge augmentation with simultaneous implant placement) |
Primary outcome
Bone quantity (crestal bone) height)
Time frame: 3 months after operation day
Cone beam
1 secondary outcome
Bone quality (bone density at the ring alveolus interface)
Time frame: 3 months after operation day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Background: PubMed 31293264Yuce MO, Adali E, Turk G, Isik G, Gunbay T. Three-dimensional bone grafting in dental implantology using autogenous bone ring transplant: Clinical outcomes of a one-stage technique. Niger J Clin Pract. 2019 Jul;22(7):977-981. doi: 10.4103/njcp.njcp_652_18.
- Background: PubMed 26644216Omara M, Abdelwahed N, Ahmed M, Hindy M. Simultaneous implant placement with ridge augmentation using an autogenous bone ring transplant. Int J Oral Maxillofac Surg. 2016 Apr;45(4):535-44. doi: 10.1016/j.ijom.2015.11.001. Epub 2015 Nov 28.
- Background: PubMed 31513341Simpson KT, Bryington M, Agusto M, Harper M, Salman A, Schincaglia GP. Computer-Guided Surgery Using Human Allogenic Bone Ring With Simultaneous Implant Placement: A Case Report. Clin Adv Periodontics. 2020 Mar;10(1):16-22. doi: 10.1002/cap.10073. Epub 2019 Oct 14.
- Background: PubMed 20218871Stevens MR, Emam HA, Alaily ME, Sharawy M. Implant bone rings. One-stage three-dimensional bone transplant technique: a case report. J Oral Implantol. 2010;36(1):69-74. doi: 10.1563/AAID-JOI-D-09-00029.
- Individual participant dataSharing planned: No
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Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
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Alveolar Ridge Augmentation, Bone Substitutes
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.
Mostafa M gad, bds principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ridge augmentation using chin bone ring with simultaneous implant placement in people with Ridge Augmentation, 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 4 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 17 Nov 2022. 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 Mostafa M gad, BDS (201000264683, mostafa.gad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone quantity (crestal bone) height) (time frame: 3 months after operation day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05620459, which also lists 4 linked publications.
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 17 Nov 2022.