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Search / Trial NCT03649100

Osseointegration With a New Hydrophilic Surface

Launched by OSSTEM AIC · Aug 25, 2018

Trial Information

Current as of May 03, 2025

Completed

Keywords

Dental Implants Implant Stability Osseointegration Isq Measurement

ClinConnect Summary

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 ea...

Gender

ALL

Eligibility criteria

  • 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

About Osstem Aic

Osstem AIC is a leading clinical trial sponsor specializing in innovative dental and medical solutions. With a commitment to advancing healthcare through rigorous research and development, Osstem AIC collaborates with healthcare professionals and institutions to conduct clinical trials that evaluate the safety and efficacy of its products. The organization emphasizes quality, transparency, and compliance with regulatory standards, aiming to enhance patient outcomes and contribute to the scientific community. Through its dedication to innovation and excellence, Osstem AIC strives to set new benchmarks in the dental and medical fields.

Locations

Rome, , Italy

Florence, , Italy

Milan, , Italy

Patients applied

0 patients applied

Trial Officials

Marco Tallarico, Dr

Principal Investigator

Osstem AIC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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