CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Extraction and Implant insertion (test) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04346706
NCT04346706N/ACompleted

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.

Saint-Joseph University·interventional·Posted Apr 15, 2020·Updated Apr 15, 2020

In Brief

A clinical study evaluating Extraction and Implant insertion (test) and Implant insertion (control) for Tooth Extraction and 2 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesLebanon
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 15, 2020
Enrollment StartFeb 10, 2018
Primary CompletionJul 20, 2019
Study CompletionNov 25, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.2 years ago

Interventions

Extraction and Implant insertion (test)device

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.

Implant insertion (control)device

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.