SA Versus SOI Surfaces for Single Implant-supported Crown

Osstem AIC100 enrolled

Overview

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 implants with SA surface modified with pH buffering agent for the rehabilitation of single implant-supported crown.

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 osseointegration. main benefits in clinical practice should be reduced treatment time.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Dental Implant Failed Bone Resorption

Interventions

Placement of dental implants (surgical procedure)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

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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.

Locations (10)

Erta Xhanari

Tirana, Albania

RECRUITING

Elitsa Deliverska

Sofia, Bulgaria

RECRUITING

Fulvio Gatti

Milan, Italy

Outcomes

Primary Outcomes

Implant failure

Implant removal for any reason will be considered an implant failure.

Time frame: From implant placement up to 60 months after loading

Crown failure

Crown replacement for any reason will be considered a crown failure.

Time frame: From crown delivery up to 60 months

Complications

Any complications will be recorded. Examples of biological complications are: nerve injury, fistula, peri-implantitis. Examples of biomechanical complications are fracture of the abutments screw, loosening of the crown, fracture of the ceramic.

Time frame: From implant placement up to 60 months after loading

Secondary Outcomes

Peri-implant marginal bone level (MBL) changes

It will be assessed on periapical radiographs taken with the paralleling technique. The distance between marginal bone level and implant/abutment junction, will be measured at both mesial and distal sides and averaged. Bone level changes at single implants will be averaged at group level. Non-digital radiographs will be scanned, digitized, and stored in a personal computer. Peri-implant marginal bone levels will be measured using the Scion Image (Scion Corporation, Frederick, MD, USA) software. The software will be calibrated for every single image using the known distance of the implant neck. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact.

Time frame: From implant placement up to 60 months after loading

Probing pocket depth (PPD)

Probing pocket depth will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA). Three vestibular and three lingual values will be collected and averaged for each implant.

Central Contacts

Marco Tallarico

CONTACT

+3280758769 me@studiomarcotallarico.it

Data from ClinicalTrials.gov

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