Osseointegration With a New Hydrophilic Surface

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-05-30

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.

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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.

Conditions

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Dental Implant Stability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Hiossen ET III NH implant

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)

Group Type EXPERIMENTAL

Implant placement

Intervention Type 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).

Hiossen ET III SA implant

Implant placement, dental implant with the conventional sandblasted and Acid-etched (SA) surface implant (Hiossen ET III Sto arrivando! implant, Sto arrivando! group)

Group Type ACTIVE_COMPARATOR

Implant placement

Intervention Type 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).

Interventions

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Implant 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).

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes