Osseointegration With a New Hydrophilic Surface

Not Applicable

Completed

• Conditions: Dental Implant Stability
• Interventions: Procedure: Implant placement

• Registration Number: NCT03649100
• Lead Sponsor: Osstem AIC

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.

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-25
• Study First Posted: 2018-08-28
• Primary Completion: 2018-12-31
• Study Completion: 2019-05-30
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-23
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Studio Odontoiatrico Marco Tallarico; 🇮🇹 Rome, Italy

Nicola Baldini; 🇮🇹 Florence, Italy

Fulvio Gatti; 🇮🇹 Milan, Italy