Osseointegration With a New Hydrophilic Surface

Sponsor

Osstem AIC (Other)

Overall Status

Completed

CT.gov ID

NCT03649100

Collaborator

(none)

Enrollment

Locations

Arms

18.9

Actual Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Implant Stability	Procedure: Implant placement	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2017

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

May 30, 2019

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Nicola Baldini	Florence	Italy
2	Fulvio Gatti	Milan	Italy
3	Studio Odontoiatrico Marco Tallarico	Rome	Italy	00151

Sponsors and Collaborators

Osstem AIC

Investigators

Principal Investigator: Marco Tallarico, Dr, Osstem AIC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marco Tallarico, Principal investigator, Osstem AIC

ClinicalTrials.gov Identifier:

NCT03649100

Other Study ID Numbers:

Osstem_002

First Posted:

Aug 28, 2018

Last Update Posted:

Jun 25, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marco Tallarico, Principal investigator, Osstem AIC

Study Results

No Results Posted as of Jun 25, 2019