Clinical trial NCT03649100: Osseointegration With a New Hydrophilic Surface
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Stability
Keywords: Dental implants
Implant stability
Osseointegration
ISQ measurement
Lead sponsor: Osstem AIC
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Implant and prosthetic success rates
timeFrame: 4 months after implant placement (baseline)
Secondary outcomes:
measure: Technical or biological complications
timeFrame: 4 months after implant placement
measure: Implant stability quotient (ISQ)
timeFrame: Each week (after implant placement) up to 8 weeks, and then 12 weeks (after implant placement)
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Nicola Baldini
city: Milan
country: Italy
facility: Fulvio Gatti
city: Rome
country: Italy
facility: Studio Odontoiatrico Marco Tallarico
Study officials:
affiliation: Osstem AIC
name: Marco Tallarico, Dr
role: PRINCIPAL_INVESTIGATOR
References: