Status:
UNKNOWN
SA Versus SOI Surfaces for Single Implant-supported Crown
Lead Sponsor:
Osstem AIC
Conditions:
Dental Implant Failed
Bone Resorption
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this randomized controlled trial is to compare clinical data and implant stability of immediately loaded TSIII Osstem implants with Sandblasted and Acid-etched (SA) surface versus impla...
Detailed Description
This study aimed to evaluate if there are some benefits using novel implant surface. This surface should improve the secondary implant stability, reducing the overall time needed for the osseointegrat...
Eligibility Criteria
Inclusion
- Any partially edentulous subject requiring at least two single (preferable non-adjacent) implant-supported crowns, being at least 18 year old and able to sign an informed consent will be screened for eligibility. Bone volumes should allow the placement of two implants at least 8.5 mm (maximum 10 mm) long and 4.5 mm (minimum 3.5 mm) wide, with a minimal insertion torque of 30 Ncm. Implants can be placed in previous post-extractive socket or in augmented bone, if at least 4 to 6 months have passed from the extraction or from augmentation procedures.
Exclusion
- Patients unable to commit to 5 years follow-up.
- 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.
Key Trial Info
Start Date :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04073654
Start Date
September 26 2019
End Date
October 15 2021
Last Update
October 1 2019
Active Locations (10)
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1
Erta Xhanari
Tirana, Albania
2
Elitsa Deliverska
Sofia, Bulgaria
3
Fulvio Gatti
Milan, Italy
4
Studio Odontoiatrico Marco Tallarico
Rome, Italy, 00151