NCT04346706

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Saint-Joseph University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tooth Extraction
• Dental Implantation
• Bone Remodeling

Interventions

Type	Name	Description
DEVICE	Extraction and Implant insertion (test)	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.
DEVICE	Implant insertion (control)	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.

Timeline

• Start date: 2018-02-10
• Primary completion: 2019-07-20
• Completion: 2019-11-25
• First posted: 2020-04-15
• Last updated: 2020-04-15

Locations

1 site across 1 country: Lebanon