Osseointegration With a New Hydrophilic Surface

Osstem AIC

Status: Completed

Conditions: Dental Implant Stability

Treatments: Procedure: Implant placement

Study type: Interventional

Funder types: Other

Identifiers

NCT03649100

Osstem_002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Hiossen ET III NH implant

Experimental group

Description:

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)

Treatment:

Procedure: Implant placement

Hiossen ET III SA implant

Active Comparator group

Description:

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

Treatment:

Procedure: Implant placement