Osseointegration With a New Hydrophilic Surface

Does the New Hydrophilic Surface Have Any Influence on Early Success Rate and Implant Stability During Osseointegration Period? A Split-mouth, Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Dental Implant Stability
• Intervention / Treatment: Procedure: Implant placement

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Florence, Italy
    • Nicola Baldini
  • Milan, Italy
    • Fulvio Gatti
  • Rome, Italy, 00151
    • Studio Odontoiatrico Marco Tallarico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Procedure: 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).
Active Comparator: 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)	Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant and prosthetic success rates	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.	4 months after implant placement (baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical or biological complications	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).	4 months after implant placement
Implant stability quotient (ISQ)	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.	Each week (after implant placement) up to 8 weeks, and then 12 weeks (after implant placement)

Collaborators and Investigators

• Sponsor: Osstem AIC
• Investigators: Principal Investigator: Marco Tallarico, Dr, Osstem AIC

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: August 17, 2018
• First Submitted That Met QC Criteria: August 25, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 23, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Dental implants; Osseointegration; Implant stability; ISQ measurement
• Other Study ID Numbers: Osstem_002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No