Clinical trial NCT04073654: SA Versus SOI Surfaces for Single Implant-supported Crown
Official title: Clinical Evaluation and Primary Stability of Early Loaded Implants With Sandblasted and Acid-etched Surface Versus Implants With SA Surface Modified With pH Buffering Agent: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implant Failed
Bone Resorption
Keywords: Dental implants
Implant surfaces
Marginal bone loss
Lead sponsor: Osstem AIC
Sponsor class: OTHER
First posted: 2019-08-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial, split-mouth design
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Implant failure
timeFrame: From implant placement up to 60 months after loading
measure: Crown failure
timeFrame: From crown delivery up to 60 months
measure: Complications
timeFrame: From implant placement up to 60 months after loading
Secondary outcomes:
measure: Peri-implant marginal bone level (MBL) changes
timeFrame: From implant placement up to 60 months after loading
measure: Probing pocket depth (PPD)
timeFrame: From crown delivery up to 60 months
measure: Bleeding on probing (BOP)
timeFrame: From crown delivery up to 60 months
measure: plaque index (PI)
timeFrame: From implant placement up to 60 months after loading
measure: Implant stability quotient
timeFrame: The ISQ values will be recorded at the time of implant placement (baseline) and then 1,2,3,4,5,6,7,8, and 12 weeks after implant placement.
measure: Pink Esthetic Score
timeFrame: From crown delivery up to 60 months
Other outcomes:
Locations:
city: Tirana
country: Albania
facility: Erta Xhanari
city: Sofia
country: Bulgaria
facility: Elitsa Deliverska
city: Milan
country: Italy
facility: Fulvio Gatti
city: Rome
country: Italy
facility: Studio Odontoiatrico Marco Tallarico
city: Siena
country: Italy
facility: Leonardo Muzzi
city: Warsaw
country: Poland
facility: Łukasz Zadrożny
city: Fatima
country: Portugal
facility: Cesaltino Remedios
city: Craiova
country: Romania
facility: Mircea
city: South Africa
country: South Africa
facility: Andre de Waal
city: Bern
country: Switzerland
facility: Nicolas Widmer
Study officials:
References: