Clinical trial NCT06286579: SOI Immediately vs Delayed
Official title: The Efficacy of New SOI Implant Surface for Immediately Loaded, Post-extractive Versus Delayed Implants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Implant
Dental Implant-Abutment Design
Keywords: Dental Implant
Immediately vs Delayes
Implant-abutment connection
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
Collaborators: name: Melodia, Dario, M.D.
name: Pisano, Milena, M.D.
name: Dr. Aurea M. I. Lumbau
name: Prof. Silvio Mario Meloni
name: Prof. Edoardo Baldoni
First posted: 2024-02-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial of parallel group design.
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled trial is to compare the clinical and radiographic of immediately loaded, immediate (post-extractive, test group) versus delayed (control group) implants with new SOI surface


Eligibility criteria: Inclusion Criteria:

* Any patient with at least one hopeless tooth in the mandible or maxilla, located between premolars, with intact post extractive alveolus. The implants must to engage at least 3 (mandible) to 5 (maxilla) mm of residual native bone over the socket.
* Patients with 18 years or older, and able to sign an informed consent.
* Smokers will be included and categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day). Heavy smokers will be excluded.
* Biotype will be categorized in thin (≤1 mm), medium (\>1 - \<2 mm) or thick (≥2 mm).

Exclusion Criteria:

* General contraindications to implant surgery.
* Patients irradiated in the head and neck area.
* Immunosuppressed or immunocompromised patients.
* Patients treated or under treatment with intravenous amino-bisphosphonates.
* Patients with untreated periodontitis.
* Patients with poor oral hygiene and motivation.
* Uncontrolled diabetes.
* Heavy smokers.
* Pregnancy or nursing.
* Substance abuser.
* Psychiatric problems or unrealistic expectations.
* Lack of opposite occluding dentition in the area intended for implant placement.
* Patients with infection and or inflammation in the area intended for implant placement.
* Patients participating in other studies, if the present protocol cannot be properly adhered to.
* Patients referred only for implant placement and cannot be followed ant the treating centre.
* Patients unable to be followed for 5 years

Primary outcomes:
measure: Number of prosthesis failure
timeFrame: Up to 5 years
measure: Number of implant failure
timeFrame: Up to 5 years
measure: Number of complications
timeFrame: Up to 5 years
Secondary outcomes:
measure: Rate of peri-implant marginal bone level changes
timeFrame: At 1,3 and 5 years
measure: Valuation of patient satisfaction
timeFrame: At 1,3 and 5 years
measure: Rate of implant stability quotient (ISQ)
timeFrame: Up to 5 years
measure: Valuation of soft tissue thickness and amount of keratinized tissue
timeFrame: 1,3 and 5 years
measure: Number of PES score
timeFrame: 1,3 and 5 years
Other outcomes:
Locations:
city: Sassari
country: Italy
facility: Marco Tallarico
Study officials:
References: