SA Versus SOI Surfaces for Single Implant-supported Crown
NCT ID: NCT04073654
Last Updated: 2019-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2019-09-26
2021-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SA Implants
Dental implant with sandblasted and Acid-etched (SA) surface
Placement of dental implants (surgical procedure)
The two study implants have to be placed in the same surgical session according to similar procedures. Implants will be placed in the planned anatomic sites by using a flapless or a miniflap approach. Implants sites will be prepared based on the bone density, and according to the manufacturers's instruction by using the 122 Taper kit (Osstem Implant).
SOI Implants
Same dental implant with sandblasted and Acid-etched surface modified with pH buffering agent
Placement of dental implants (surgical procedure)
The two study implants have to be placed in the same surgical session according to similar procedures. Implants will be placed in the planned anatomic sites by using a flapless or a miniflap approach. Implants sites will be prepared based on the bone density, and according to the manufacturers's instruction by using the 122 Taper kit (Osstem Implant).
Interventions
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Placement of dental implants (surgical procedure)
The two study implants have to be placed in the same surgical session according to similar procedures. Implants will be placed in the planned anatomic sites by using a flapless or a miniflap approach. Implants sites will be prepared based on the bone density, and according to the manufacturers's instruction by using the 122 Taper kit (Osstem Implant).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* General contraindications to implant surgery.
* Less then 4 mm of keratinised gingiva crestally (at the implant sites).
* Immune-suppressed/compromised patients.
* Patients irradiated in the head and/or neck.
* Uncontrolled diabetes.
* Pregnancy or lactation.
* Untreated periodontal disease.
* Poor oral hygiene and motivation (full mouth bleeding and full mouth plaque index higher than 25%).
* Addiction to alcohol or drugs.
* Psychiatric problems and/or unrealistic expectations.
* Patients with an acute infection or suppuration in the site intended for implant placement.
* Patients needing any form of tissue augmentation at implant placement.
* Immediate post-extractive implants (implants can be placed after a 3-month healing period).
* Patients treated or under treatment with intravenous amino-bisphosphonates.
* Patients referred only for implant placement if the follow-up cannot be done at the treatment center.
* Patients participating in other studies, if the present protocol could not be fully adhered to.
18 Years
ALL
Yes
Sponsors
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Osstem AIC
OTHER
Responsible Party
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Marco Tallarico
Coordinator
Locations
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Erta Xhanari
Tirana, , Albania
Elitsa Deliverska
Sofia, , Bulgaria
Fulvio Gatti
Milan, , Italy
Studio Odontoiatrico Marco Tallarico
Rome, , Italy
Leonardo Muzzi
Siena, , Italy
Łukasz Zadrożny
Warsaw, , Poland
Cesaltino Remedios
Fátima, , Portugal
Mircea
Craiova, , Romania
Andre de Waal
South Africa, , South Africa
Nicolas Widmer
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SOI_1_RCT_MT
Identifier Type: -
Identifier Source: org_study_id
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