Dental Implant Stability
Conditions
Keywords
Dental implants, Implant stability, Osseointegration, ISQ measurement
Brief summary
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
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.
Interventions
PROCEDUREImplant placement
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).
Sponsors
Osstem AIC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant and prosthetic success rates | 4 months after implant placement (baseline) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical or biological complications | 4 months after implant placement | 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). |
| Implant stability quotient (ISQ) | Each week (after implant placement) up to 8 weeks, and then 12 weeks (after implant placement) | 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. |
Countries
Italy
Outcome results
None listed