Osseointegration With a New Hydrophilic Surface

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Does the New Hydrophilic Surface Have Any Influence on Early Success Rate and Implant Stability During Osseointegration Period? A Split-mouth, Randomised Controlled Trial

Conditions
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Dental Implant Stability

Intervention / Treatment
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* Procedure: Implant placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any healthy patients Aged 18 years or older Requiring at least two implants to be rehabilitated with a fixed implant supported restoration Full mouth bleeding and full mouth plaque index lower than or equal to 25% Sufficient bone to allow placement of at least 11.5 mm-long implants, and bone width of at least six to eight mm for the placement of a regular platform Hiossen ET III implant (Deutsche Osstem GmbH, Eschborn, Germany). Exclusion Criteria: Positive medical findings Psychiatric therapy Pregnancy or nursing Smoking more than 10 cigarettes per day Insertion torque < 35 Ncm Untreated periodontitis Acute and chronic infections of the adjacent tissues or natural dentition Previous radiotherapy of the oral and maxillofacial region within the last five years Post-extractive implants (at least three months after tooth extraction) Absence of teeth in the opposing jaw Severe clenching or bruxism Severe maxillo-mandibular skeletal discrepancy Poor oral hygiene

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hiossen ET III NH implant<br>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) | Procedure: Implant placement<br>* 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).<br>|
| Active Comparator: Hiossen ET III SA implant<br>Implant placement, dental implant with the conventional sandblasted and Acid-etched (SA) surface implant (Hiossen ET III Sto arrivando! implant, Sto arrivando! group) | Procedure: Implant placement<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental implants, Implant stability, Osseointegration, ISQ measurement