Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study was conducted to compare implant stability of Hiossen ET III implants with its new hydrophilic surface (NH) and Hiossen ET III implants with the SA surface.
Patients required at least two teeth to be rehabilitated with a fixed, implant-supported restoration, consecutively enrolled. Patients randomly received Sandblasted and Acid-etched (SA) surface implants (SA group) or SA implants with a newly developed bio-absorbable apatite nano coating (NH group). Outcome measures were: implant and prosthetic survival rate, complications, insertion torque, and implant stability quotient (ISQ) measured at implant placement and every week up to 8 weeks after implant placement. Comparison between groups was made by unpaired t test, while comparison between each follow-up will be made by paired t tests to detect any change during the follow-up. Complications and failures were compared by using Fisher exact test.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hiossen ET III NH implant | Experimental | Implant placement, dental implant with Sandblasted and Acid-etched (SA) surface implant and newly developed bio-absorbable apatite nano coating (Hiossen ET III NH implant, NH group) |
|
| Hiossen ET III SA implant | Active Comparator | Implant placement, dental implant with the conventional sandblasted and Acid-etched (SA) surface implant (Hiossen ET III Sto arrivando! implant, Sto arrivando! group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant placement | Procedure | Conventional implant placement. Implant site development was prepared according to the manufacturer's instruction by the investigator, before knowing the randomized implant (NH or SA). |
| Measure | Description | Time Frame |
|---|---|---|
| Implant and prosthetic success rates | Success rates of the implants and prostheses were evaluated by an independent assessor (EX). An implant was considered a failure if it presented mobility, assessed after the osseointegration period by tapping or rocking the implant head with the metallic handles of two instruments, progressive marginal bone loss or infection, or any mechanical complications rendering the implant unusable, although still mechanically stable in the bone. A prosthesis was considered a failure if it needed to be replaced with another prosthesis. | 4 months after implant placement (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Technical or biological complications | Any biological complication, such as pain, swelling, and or suppuration, as well as any technical complication, such as screw loosening, fracture of the framework and/or the veneering material will be recorded during the follow-up period. Complications were evaluated and treated by the same surgeon (MT). | 4 months after implant placement |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marco Tallarico, Dr | Osstem AIC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nicola Baldini | Florence | Italy | ||||
| Fulvio Gatti |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To randomly compare implant stability quotient (ISQ) of Hiossen ET III implants with its new hydrophilic surface (NH) and Hiossen ET III implants with the conventional SA surface, in a split-mouth randomized study.
Not provided
Not provided
A blinded collaborator opened the opaque envelope after implant site development, giving the implant to the investigator that remain blinded. Both the test and control implants are perfectly the same.
| Implant stability quotient (ISQ) | Implant stability quotient (ISQ) values were recorded each week up to 8 weeks, and then after 12 weeks, using resonance frequency analysis (Osstell Mentor device, Osstell, Gothenburg, Sweden). Each implant was measured twice. First in a messy-distal direction and then in a buck-lingual direction. The mean value was recorded. | Each week (after implant placement) up to 8 weeks, and then 12 weeks (after implant placement) |
| Milan |
| Italy |
| Studio Odontoiatrico Marco Tallarico | Rome | 00151 | Italy |