Immediate Implant Placement in Fresh Extraction Sockets and Delayed Implants in Healed Sockets.

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective clinical study was to compare in delayed and immediately placed implants, the marginal vertical bone loss at 4 sides of the implant (buccal, palatal, mesial and distal), as well as the buccal and palatal bone thickness reduction at 3 months after loading.

Detailed Description
-----------------
Twenty-four patients were consecutively selected and enrolled in this study based on the aforementioned exclusion and inclusion criteria. Clinical examination was done by a different clinician than the operator, and according to the treatment indication, patients were allocated to the delayed implant placement group (Control), or the immediate implant placement group (Test). Thus, 15 implants were placed in healed extraction sites and immediately temporized (Control group), and 15 implants were placed in immediate extraction sites with immediate temporization (Test group). Provisional acrylic crowns were prepared. All patients were placed on a prophylactic antibiotic regimen, starting one day prior to surgery as they were asked to take amoxicillin 500 mg; three times a day for 10 days or clindamycin 300 mg twice daily for 10 days for penicillin-allergic patients. For the test group, tooth extractions were carried out atraumatically using periotomes. In both groups, the implant site preparation was completed in compliance with the general surgical principles and protocols defined by the manufacturer and screw-shaped implants (UFII, DIO™) were inserted at no less than 35 Ncm. Temporary abutments were connected to the implants and torqued at 20 Ncm, and then temporary crowns were cemented on top of the abutments after checking and reducing occlusion to non-existent in both centric and lateral excursions.

Official Title
-----------------
Radiographic Evaluation of Marginal Bone Level, Buccal and Palatal Plate Thickness Alteration, and Implant Stability After Placement in Healed Ridges and Fresh Extraction Sockets: A 6 Months Prospective Study.

Conditions
-----------------
Tooth Extraction, Dental Implantation, Bone Remodeling

Intervention / Treatment
-----------------
* Device: Extraction and Implant insertion (test)
* Device: Implant insertion (control)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over 18 years old, compliant (willing to show up to all their follow-up visits), and able to read, understand and sign an informed consent. All patients were to have good oral hygiene levels (full mouth plaque scores (FMPS) <15-20%, and full mouth bleeding index (FMBI) <15-20%), requiring implant insertion in a maxillary premolar site either immediately or in a healed pristine bone. Exclusion Criteria: Presence of major contraindications to implant surgery, patients that had received head and neck radiation for cancer treatment, immunosuppressed or immunocompromised patients, uncontrolled diabetes, pregnant or breast-feeding woman, untreated periodontitis and/or poor oral hygiene and motivation, presence of buccal dehiscence, and finally previous bone grafting or ridge preservation in the studied area.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate implantation<br>Tooth extraction, immediate insertion of an implant with immediate temporization | Device: Extraction and Implant insertion (test)<br>* The surgical procedure was conducted under local anesthesia. Intrasulcular incisions were performed around the mesial and distal tooth to the implant recipient site. Buccal and palatal mucoperiosteal flaps were elevated. Tooth extractions were carried out atraumatically using periotomes. Implant site preparation was completed in compliance with the general surgical principles and protocols defined by the manufacturer and screw-shaped implants (UFII, DIO™) were inserted at no less than 35 Ncm. Final insertion torque (IT) was measured and recorded using a manual hand wrench (DIO™). Resonance frequency analysis (RFA) was performed using an Osstell device (Sävedalen, Sweden). For each implant, three Implant Stability Quotient (ISQ) readings were recorded by the same operator to calculate the mean ISQ, at implant placement (T0) and 3 months after implant insertion (T3) prior to final abutment torque and crown cementation. Absorbable interrupted 4.0 sutures were used for flap closure.<br>|
| Experimental: Delayed implantation<br>Implant inserted in a healed socket with immediate temporization | Device: Implant insertion (control)<br>* The surgical procedure was conducted under local anesthesia. Intrasulcular incisions were performed around the mesial and distal tooth to the implant recipient site. Buccal and palatal mucoperiosteal flaps were elevated, the implant site preparation was completed in compliance with the general surgical principles and protocols defined by the manufacturer and screw-shaped implants (UFII, DIO™) were inserted at no less than 35 Ncm. Final insertion torque (IT) was measured and recorded using a manual hand wrench (DIO™). Resonance frequency analysis (RFA) was performed using an Osstell device (Sävedalen, Sweden). For each implant, three Implant Stability Quotient (ISQ) readings were recorded by the same operator to calculate the mean ISQ. This was done at implant placement (T0) and 3 months after implant insertion (T3) prior to final abutment torque and crown cementation. Absorbable interrupted 4.0 sutures were used for flap closure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of marginal vertical bone level at 6 months | Marginal vertical bone level changes at 4 sides of the implant (buccal, palatal, mesial and distal) on Cone Beam Computed Tomography (CBCT) images | Following procedure at day 0 (implant insertion) and 6 months (post-implantation) | 
| Change from baseline of bone plate thickness at 6 months | Buccal and palatal bone thickness at 4 levels : 0 mm, 2 mm, 4 mm and 6 mm from the implant platform on CBCT images | Following procedure at day 0 (implant insertion) and 6 months (post-implantation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of implant stability quotient at 3 months | Measurements of implant stability quotient (ISQ) following implant insertion | Following procedure at day 0 (implant insertion) and 3 months (post-implantation) | 
| Record of insertion torque | Insertion torque value at implant placement | Following procedure at day 0 (implant insertion) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental implantation, Immediate dental implant loading, Marginal bone remodeling