Immediate Implant PlacementNCT05436158
The Use of a New Safe Angle Position for Implant Placement in the Anterior Region.
An observational study of Immediate Implant Placement and Esthetic Zone, run by Cairo University at 2 sites in Egypt.
Trial summary
There is an angle between the intersection of the incisal long axis perpendicular to the palate or the occlusal plane, and the long axis of the root. When this relation is shifted more palatal, where the incisal plane line will be at the cingulum position or slightly palatal to it, it is named the safe angle position. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant Placement, Esthetic Zone, Anterior Maxilla
- What is being tested?
- Implant placement in the safe angle position in the anterior maxilla
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2022to Sep 2022
- Phase
- Observational
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with immediate implants in the anterior region
Who may be able to join
- Patients with immediate implants in the anterior region
- Patient with preoperative and postoperative CBCT
- Provide informed consent.
Who cannot join
- patients without a preoperative CBCT.
- 2- patients without an informed consent.
Trial locations and contacts
2 sites in 1 country.
Noha A Ghallab, PhD contact
Egypt2 sites, 2 recruiting
- Recruiting
International Dental Continuing Education
Cairo, Maadi, 11728
Ahmed I Abou- El-Fettouh, MSc, ahmedkey7@hotmail.com
Nael A Mina, BDS
- Recruiting
Faculty of Dentistry, Cairo University
Cairo, Manial, 35855
Nesma M Shemais, PhD, nesma.shemais@dentistry.cu.edu.eg
About this study
Official title: The Use of a New Safe Angle Position for Implant Placement in the Anterior Region: A Cross-sectional Study
There is an angle between the intersection of the incisal long axis perpendicular to the palate or the occlusal plane, and the long axis of the root. When this relation is shifted more palatal, where the incisal plane line will be at the cingulum position or slightly palatal to it, it is named the safe angle position. The more palatal relocation to the cingulum is performed according to the availability of palatal bone, the occlusion with the opposing dentition, the type of the restoration (screw vs cemented).
The possibility of having a specific safe angle to place implants opens new interesting perspectives for immediate placement of dental implants.
The aim of the present study was to demonstrate how immediate implants in the safe angle position can be predictably achieve proper implant positioning, better esthetics and emergence profile as well as less stresses on the implant.
Read the detailed description
Immediate implants are implants inserted immediately after surgical extraction of the teeth to be replaced. Creation of an anatomically correct emergence profile is one of the most important aspects in providing an esthetically pleasing implant-supported restoration. Dentists understand the risks involved when restored prostheses are subjected to non-axial loading. It has always been recommended to direct occlusal loads as close to the long axis of the fixture as possible. However, it is known that the loading on angled abutments is mostly off-axis, which raises the concern of how angled abutments generally perform with such an unfavourable loading regimen.
There is an angle between the intersection of the incisal long axis perpendicular to the palate or the occlusal plane, and the long axis of the root. When this relation is shifted more palatal, where the incisal plane line will be at the cingulum position or slightly palatal to it, it is named the safe angle position. The more palatal relocation to the cingulum is performed according to the availability of palatal bone, the occlusion with the opposing dentition, the type of the restoration (screw vs cemented).
The possibility of having a specific safe angle to place implants opens new interesting perspectives for immediate placement of dental implants.
The aim of the present study was to demonstrate how immediate implants in the safe angle position can be predictably achieve proper implant positioning, better esthetics and emergence profile as well as less stresses on the implant.
- Being tested
- Implant placement in the safe angle position in the anterior maxilla
- Keywords
- Immediate dental implants, anterior maxilla, safe angle position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant placement in the safe angle position in the anterior maxillaOther
After assessing the CBCT of patients, the immediate implants will be assessed if they were placed in the safe zone. the safe zone is described as; that there is an angle between the intersection of the incisal long axis perpendicular to the palate or the occlusal plane, and the long axis of the root. When this relation is shifted more palatal, where the incisal plane line will be at the cingulum position or slightly palatal to it, it is named the safe angle position. The more palatal relocation to the cingulum is performed according to the availability of palatal bone, the occlusion with the opposing dentition, the type of the restoration (screw vs cemented).
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of the implant in the safe angle
binary (Y/N) from CBCT
Measured: 6 months
use of angled or straight abutment
Binary (straight/angled)
Measured: 6 months
Secondary outcomes (1)
Pink Esthetic Score
Pink Esthetic Score (1-14)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 May 2022
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Implant PlacementStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Mohamed Fouad Shemais, Cairo University
- Investigators
- Noha A Ghallab, PhD, Study chair, Professor of Oral Medicine & PeriodontologyAhmed I Abou- El-Fettouh, MSc, Principal investigator, MIUAbdelrahman Zohny, BDs, Principal investigator, MIUNael M Adel, BDs, Principal investigator, MIUMariam S Abdelmalak, BDs, Principal investigator, MIUNesma M Shemais, PhD, Principal investigator, Lecturer of Oral Medicine & Periodontology, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436158
- Sponsor's protocol ID
- IDCE.N2
- Status last verified
- Jun 2022
- First submitted
- 19 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- 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 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a New Safe Angle Position for Implant Placement in the Anterior Region: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05436158
- Acronym / sponsor ID
- IDCE.N2
- Keywords
- Immediate dental implants, anterior maxilla, safe angle position
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 28 Jun 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.
There is an angle between the intersection of the incisal long axis perpendicular to the palate or the occlusal plane, and the long axis of the root. When this relation is shifted more palatal, where the incisal plane line will be at the cingulum position or slightly palatal to it, it is named the safe angle position. The more palatal relocation to the cingulum is performed according to the availability of palatal bone, the occlusion with the opposing dentition, the type of the restoration (screw vs cemented).
The possibility of having a specific safe angle to place implants opens new interesting perspectives for immediate placement of dental implants.
The aim of the present study was to demonstrate how immediate implants in the safe angle position can be predictably achieve proper implant positioning, better esthetics and emergence profile as well as less stresses on the implant.
Detailed description
Immediate implants are implants inserted immediately after surgical extraction of the teeth to be replaced. Creation of an anatomically correct emergence profile is one of the most important aspects in providing an esthetically pleasing implant-supported restoration. Dentists understand the risks involved when restored prostheses are subjected to non-axial loading. It has always been recommended to direct occlusal loads as close to the long axis of the fixture as possible. However, it is known that the loading on angled abutments is mostly off-axis, which raises the concern of how angled abutments generally perform with such an unfavourable loading regimen.
There is an angle between the intersection of the incisal long axis perpendicular to the palate or the occlusal plane, and the long axis of the root. When this relation is shifted more palatal, where the incisal plane line will be at the cingulum position or slightly palatal to it, it is named the safe angle position. The more palatal relocation to the cingulum is performed according to the availability of palatal bone, the occlusion with the opposing dentition, the type of the restoration (screw vs cemented).
The possibility of having a specific safe angle to place implants opens new interesting perspectives for immediate placement of dental implants.
The aim of the present study was to demonstrate how immediate implants in the safe angle position can be predictably achieve proper implant positioning, better esthetics and emergence profile as well as less stresses on the implant.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with immediate implants in the anterior region
Key inclusion criteria (3 listed)
- Patients with immediate implants in the anterior region
- Patient with preoperative and postoperative CBCT
- Provide informed consent.
Key exclusion criteria (2 listed)
- patients without a preoperative CBCT.
- 2- patients without an informed consent.
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 |
|---|---|---|
| Implant placement in the safe angle position in the anterior maxillaAfter assessing the CBCT of patients, the immediate implants will be assessed if they were placed in the safe zone. the safe zone is described as; that there is an angle between the intersection of the incisal long axis perpendicular to the palate or the occlusal plane, and the long axis of the root. When this relation is shifted more palatal, where the incisal plane line will be at the cingulum position or slightly palatal to it, it is named the safe angle position. The more palatal relocation to the cingulum is performed according to the availability of palatal bone, the occlusion with the opposing dentition, the type of the restoration (screw vs cemented). | Other | – |
Primary outcome
presence of the implant in the safe angle
Time frame: 6 months
binary (Y/N) from CBCT
use of angled or straight abutment
Time frame: 6 months
Binary (straight/angled)
1 secondary outcome
Pink Esthetic Score
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- 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. This study is not recruiting at the moment.
Noha A Ghallab, PhD contact
Noha A Ghallab, PhD study chair
Professor of Oral Medicine & Periodontology
Ahmed I Abou- El-Fettouh, MSc principal investigator
MIU
Abdelrahman Zohny, BDs principal investigator
MIU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immediate Implant Placement and Esthetic Zone, run by Cairo University at 2 sites 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 2 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 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Nesma M Shemais, PhD (01005615697, nesma.shemais@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of the implant in the safe angle (time frame: 6 months). The study lists 2 primary outcomes in all. 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 28 Jun 2022.