Clinical trial NCT05750004: Deviation Between Virtual and Actual Computer Guided Immediate Implants Using the New Safe Angle Position Concept
Official title: Deviation Between Virtual and Actual Computer Guided Immediate Implant Placement in Anterior Maxilla Using the New Safe Angle Position Concept and Resultant Effects on Soft and Hard Tissues (A Case Series Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immediate Implants
Keywords: Immediate implant placement
computer guided
safe angle position
Angular deviation
Lead sponsor: Misr International University
Sponsor class: OTHER
Collaborators: name: Institut Straumann AG
First posted: 2023-03-01
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this case series study is to assess the degree of angular deviation between virtual and actual computer guided immediate implant placement in anterior maxilla using the new safe angle position concept and the resultant effects on soft and hard tissues. Patients with non-restorable anterior maxillary teeth will be managed with flapless computer guided immediate implant placement fabricated using safe angle concept.

Detailed description: Various research investigated the distance deviations at the entrance and apical points of angular deviation to investigate the clinical accuracy of implant placement using these surgical procedures. Additionally, the 3D variations between the intended and postoperative implant placements are evaluated in the mesio-distal, bucco-lingual, and vertical directions. The vertical orientations are all constrained by bone volume; nevertheless, the greatest contributors to 3D deviations in implant location are bucco-lingual and mesio-distal deviations. Few research have been done to examine the variables affecting implant placement accuracy using free-hand surgical procedures. Due to drilling errors caused by drills travelling along the paths of least resistance during IIP and socket morphology, implants frequently end up in the facial region even when surgical guidelines are present. This is more typical for anterior maxilla implants. The incisal long axis, which is perpendicular to the palate or the occlusal plane, and the root's long axis connect at an angle. The incisal plane line will be at the cingulum position or slightly palatal to it when this relation is shifted more palatally, and this position is known as the safe angle position. According to the amount of palatal bone present, the occlusion with the opposing dentition, and the type of restoration, the more palatal relocation to the cingulum is carried out. Immediate implants in the safe angle position are more likely to predictably achieve good implant location (less angular deviation), improved aesthetics and emergence profile, and less stresses on the implant.

Eligibility criteria: Inclusion Criteria:

1. Adults ≥ 20 years to 50 years of both genders and in good general health.
2. Maxillary anterior tooth that cannot be retained due to non-periodontitis, including fracture, endodontic failure, and root resorption, bounded by natural teeth.
3. Intact buccal bone plate (via CBCT).
4. The extraction socket has at least 3-5 mm apical bone.

Exclusion Criteria:

* 1. Smokers 2. Pregnant and lactating females: Pregnancy as this will limit recording the outcome data eg: CBCT.

  3. Medically compromised patients, as uncontrolled diabetic patients, patients taking bisphosphonates injection for treatment of osteoporosis, patients with active cardiac diseases, patients undergoing radiotherapy or chemotherapy, or any other medical and general contraindications for the surgical procedure (i.e. ASA score ≥III) (31) 4. Patients with active infection related at the site of implant/bone graft placement.

  5. Patients with untreated active periodontal diseases. 6. Patients with parafunctional habits. 7. Refuse to participate in this study.

Primary outcomes:
measure: Angular deviations
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: International Dental Contining Education Centre (IDCE)
Study officials:
References: