SOI Immediately vs Delayed

NCT06286579 | Not Yet Recruiting

• 1 other identifier: UNISS_PHD_Osstem_3
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Dental Implant; Dental Implant-Abutment Design

Keywords

Dental Implant; Immediately vs Delayes; Implant-abutment connection

Outcome Measures

Primary Outcomes (3)

• Number of prosthesis failure

  Whether it will not be possible to place the prosthesis because of implant failure or a prosthesis that has to be remade for any reason.

  Up to 5 years

• Number of implant failure

  defined as implant mobility and/or any infection dictating implant removal, and/or implant fracture and/or any other mechanical complication rendering the implant unusable. The stability of each individual implant will be measured by the local blinded outcome assessors manually tightening the screws with a torque of 30 Ncm at abutment connection, immediately loading, at 1,3 and 5 years after loading for the partial fixed prostheses. Once the single crowns will be cemented, their stability will be assessed by rocking the crown with the handles of two dental instruments.

  Up to 5 years

• Number of complications

  Technical (fracture of the framework and/or the veneering material, screw loosening, etc.) and/or biologic (pain, swelling, suppuration, peri-implantitis, etc.) complication will be considered.

  Up to 5 years

Secondary Outcomes (5)

• Rate of peri-implant marginal bone level changes

  At 1,3 and 5 years

• Valuation of patient satisfaction

  At 1,3 and 5 years

• Rate of implant stability quotient (ISQ)

  Up to 5 years

• Valuation of soft tissue thickness and amount of keratinized tissue

  1,3 and 5 years

• Number of PES score

  1,3 and 5 years

Study Arms (2)

Immediately implant placement

EXPERIMENTAL

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

Device: Immediately implant placement

Delayed implant placement

ACTIVE COMPARATOR

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

Device: Delayed

Interventions

Immediately implant placement DEVICE

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

Immediately implant placement

Delayed DEVICE

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 restoration will be delivered

Delayed implant placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Sassari: lead
• Melodia, Dario, M.D.: collaborator
• Pisano, Milena, M.D.: collaborator
• Dr. Aurea M. I. Lumbau: collaborator
• Prof. Silvio Mario Meloni: collaborator
• Prof. Edoardo Baldoni: collaborator

Study Sites (1)

Marco Tallarico

Sassari, 07100, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: One "blinded (when possible)" independent assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Randomised controlled trial of parallel group design.

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: February 29, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2024
• Study Completion (Estimated): January 31, 2028
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)