NCT03649100

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

1.2 years

First QC Date

August 17, 2018

Last Update Submit

June 23, 2019

Conditions

Dental Implant Stability

Keywords

Dental implantsImplant stabilityOsseointegrationISQ measurement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Technical or biological complications

    4 months after implant placement

  • Implant stability quotient (ISQ)

    Each week (after implant placement) up to 8 weeks, and then 12 weeks (after implant placement)

Study Arms (2)

Hiossen ET III NH implant

EXPERIMENTAL

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

Hiossen ET III SA implant

ACTIVE COMPARATOR

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

Interventions

Implant placementPROCEDURE

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 NH implantHiossen ET III SA implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Nicola Baldini

Florence, Italy

Location

Fulvio Gatti

Milan, Italy

Location

Studio Odontoiatrico Marco Tallarico

Rome, 00151, Italy

Location

Study Officials

  • Marco Tallarico, Dr

    Osstem AIC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 17, 2018

First Posted

August 28, 2018

Study Start

November 1, 2017

Primary Completion

December 31, 2018

Study Completion

May 30, 2019

Last Updated

June 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(3)