Digital Implant Dentistry, Immediate Dental Implant Placement, Immediate Loading, Provisional Restoration, Tooth Loss in the Esthetic Zone Requiring Immediate Implant Placement
Conditions
Keywords
Immediate implant placement, Immediate loading, Digital workflow, Guided implant surgery, Provisional restoration, 3D-printed resin, CAD/CAM-milled PMMA, Maxillary esthetic zone, Customized healing abutment, Peri-implant soft tissue
Brief summary
A randomized clinical trial comparing 3D-printed resin and CAD/CAM-milled PMMA provisional restorations used for immediate loading of fully digitally guided immediate implants.
Detailed description
Sixty patients were randomly allocated to receive either a 3D-printed resin or a CAD/CAM-milled PMMA provisional crown used for immediate loading after fully digitally guided immediate implant placement in the maxillary esthetic zone. Clinical and peri-implant soft tissue outcomes will be evaluated.
Interventions
PROCEDURE3D-Printed Resin Provisional Crown
A digitally designed and 3D-printed resin immediate provisional crown was delivered immediately after fully guided implant placement in the maxillary esthetic zone and served as a customized healing abutment.
PROCEDURECAD/CAM-Milled PMMA Provisional Crown
A digitally designed CAD/CAM-milled PMMA immediate provisional crown was delivered immediately after fully guided implant placement in the maxillary esthetic zone and served as a customized healing abutment.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patients presenting with non-restorable teeth in the maxillary esthetic zone indicated for extraction and immediate implant placement. * Age ranging from 18 to 50 years. * Adequate interarch relationship and interocclusal space to accommodate the planned prosthetic restoration. * Intact extraction socket walls with a jumping gap not exceeding 4 mm, as measured on preoperative CBCT images. The jumping gap will be defined as the horizontal distance between the implant surface and the inner aspect of the buccal socket wall and will be grafted in all cases. * Good oral hygiene and periodontal health. * Willingness to attend all follow-up visits and comply with study requirements.
Exclusion criteria
* Presence of acute infection, pathological lesions, or severe periodontal disease at the planned implant site. * Smokers. * Alcohol or drug abuse. * Patients with systemic conditions contraindicating implant surgery (e.g., uncontrolled diabetes mellitus, bleeding disorders, immunosuppression, recent radiotherapy to the head and neck region). * Pregnancy or lactation. * Patients with parafunctional habits such as bruxism or clenching. * Inability to maintain adequate oral hygiene or attend follow-up visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peri-implant soft tissue changes | Baseline (immediately after provisionalization), 1 month, 3 months, and 6 months postoperatively. | Soft tissue contour and peri-implant tissue condition will be assessed using digital intraoral scanning (STL files) using superimposition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pink Esthetic Score (PES) | After 3 and 6 months postoperatively. | Peri-implant soft tissue esthetics were assessed using the Pink Esthetic Score (0-14). Higher scores indicated better esthetic outcomes. |
| Implant stability | Immediate post-operative and at 3 months. | Implant stability will be evaluated using Osstell device based on resonance frequency analysis (ISQ values). |
Countries
Egypt
Outcome results
None listed