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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05436158
Other study ID # IDCE.N2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date September 2022

Study information

Verified date June 2022
Source Cairo University
Contact Nesma M Shemais, PhD
Phone 01005615697
Email nesma.shemais@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 2022
Est. primary completion date August 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: 1. Patients with immediate implants in the anterior region 2. Patient with preoperative and postoperative CBCT 3. Provide informed consent. Exclusion Criteria: 1. patients without a preoperative CBCT. 2. 2- patients without an informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Implant placement in the safe angle position in the anterior maxilla
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).

Locations

Country Name City State
Egypt Faculty of Dentistry, Cairo University Cairo Manial
Egypt International Dental Continuing Education Cairo Maadi

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary presence of the implant in the safe angle binary (Y/N) from CBCT 6 months
Primary use of angled or straight abutment Binary (straight/angled) 6 months
Secondary Pink Esthetic Score Pink Esthetic Score (1-14) 6 months
See also
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Active, not recruiting NCT05670067 - Alveolar Ridge and Soft Tissue Augmentation Using Graft From the Maxillary Tuberosity N/A
Completed NCT05990283 - Socket Shield Technique and Guided Bone Regeneration N/A
Withdrawn NCT06038695 - Immediate Implant Placement Using Volume-Stable Collagen Matrix Combined With rhPDGF-BB N/A
Not yet recruiting NCT06246253 - Bone Formed Labial to the Implant in Relation to the Horizontal Gap Dimension in Immediate Implant Placement.
Not yet recruiting NCT06207565 - Immediate Implant Placement Utilizing Vestibular Flap Versus Single Flap Approach With Bone Graft N/A
Enrolling by invitation NCT05330702 - Ultrasound-based Imaging to Detect Early Changes of Hard and Soft Tissue Around Immediately Placed Implants With or Without Soft Tissue Augmentation N/A
Enrolling by invitation NCT05880771 - Immediate Implant Placement: a Clinical and Radiographic Study on Hard and Soft Tissues Retraction at One Year. N/A
Completed NCT04795102 - Effect of "Autogenous Leukocyte Platelet Rich Fibrin- Tooth Graft" Combination Around Immediately Placed Implants N/A
Completed NCT03422458 - The Impact of Immediate Implant Placement on Alveolar Ridge Preservation Techniques N/A
Completed NCT04803500 - Simvastatin Around Immediate Implant Phase 2