SOI Immediately vs Delayed

Università degli Studi di Sassari

Status: Not yet enrolling

Conditions: Dental Implant; Dental Implant-Abutment Design

Treatments: Device: Immediately implant placement; Device: Delayed

Study type: Interventional

Funder types: Other

Identifiers

NCT06286579

UNISS_PHD_Osstem_3

Details and patient eligibility

About

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

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

70 participants in 2 patient groups

Immediately implant placement

Experimental group

Description:

Atraumatic tooth extraction and immediately placement of implant with a new surface

Treatment:

Device: Immediately implant placement

Delayed implant placement

Active Comparator group

Description:

Atraumatic tooth extraction, after the site will be left to heal for 4 months, just grafting with A-Oss and suture, according to a socket preservation procedure. Four month later, implant will be place

Treatment:

Device: Delayed