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Completed

NCT Number: NCT03649100

Osseointegration With a New Hydrophilic Surface

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.

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Key information

Conditions

Dental Implant Stability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nicola Baldini, Florence, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

implant placement

Procedure

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).

Primary outcomes

  1. Implant and prosthetic success rates

    Time frame: 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 outcomes

  1. Technical or biological complications

    Time frame: 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).

  2. Implant stability quotient (ISQ)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Osstem AIC

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 28, 2018
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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