SOI Immediately vs Delayed

Official title

The Efficacy of New SOI Implant Surface for Immediately Loaded, Post-extractive Versus Delayed Implants

Overview

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

Interventions

• Device Immediately implant placement
  After atraumatic tooth extraction immediate implant placement with SOI surface and loading will be performed with temporary restoration. After osseointegration (8 weeks), the temporary restoration will be modified according to the soft tissue management. After 3 to 4 months, a definitive digital or analog impression will be taken and later definitive restoration will be delivered
• Device Delayed
  After atraumatic tooth extraction, the extraction 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 and immediate loadind with temporary restoration will be performed. After osseointegration (8 weeks), the temporary restoration will be modified according to the soft tissue management. After 3 to 4 months, a definitive digital or analog impression will be taken and later definitive re

Primary outcome measures

• Number of prosthesis failure [Time frame: Up to 5 years]
• Number of implant failure [Time frame: Up to 5 years]
• Number of complications [Time frame: Up to 5 years]

Secondary outcome measures (5)

• Rate of peri-implant marginal bone level changes [Time frame: At 1,3 and 5 years]
• Valuation of patient satisfaction [Time frame: At 1,3 and 5 years]
• Rate of implant stability quotient (ISQ) [Time frame: Up to 5 years]
• Valuation of soft tissue thickness and amount of keratinized tissue [Time frame: 1,3 and 5 years]
• Number of PES score [Time frame: 1,3 and 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 1 center

• Marco Tallarico — Sassari

Identifiers

NCT: NCT06286579 · UNISS_PHD_Osstem_3

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗