Does the New Hydrophilic Surface Have Any Influence on Early Success Rate and Implant Stability During Osseointegration Period? A Split-mouth, Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Implant Stability
- Sponsor
- Osstem AIC
- Enrollment
- 24
- Locations
- 3
- Primary Endpoint
- Implant and prosthetic success rates
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Marco Tallarico
Principal investigator
Osstem AIC
Eligibility Criteria
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
Outcomes
Primary Outcomes
Implant and prosthetic success rates
Time Frame: 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 Outcomes
- Technical or biological complications(4 months after implant placement)
- Implant stability quotient (ISQ)(Each week (after implant placement) up to 8 weeks, and then 12 weeks (after implant placement))