SOI Immediately vs Delayed

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Implant; Dental Implant-Abutment Design
• Intervention / Treatment: Device: Immediately implant placement; Device: Delayed

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Sassari, Italy, 07100
    • Marco Tallarico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediately implant placement; Atraumatic tooth extraction and immediately placement of implant with a new surface	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
Active Comparator: Delayed implant placement; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of peri-implant marginal bone level changes	Peri-implant marginal bone level changes will be assessed on periapical radiographs took with the paralleling technique at implant placement, at initial loading, 1,3 and 5 years after loading. Ideally digital radiographs should be taken, otherwise radiographs on conventional films will be scanned into TIFF format with a 600 dpi resolution, and stored in a personal computer. Peri-implant marginal bone levels will be measured using the Scion Image (Scion Corporation, Frederick, MD, USA) software. The software will be calibrated for every single image using the known distance of the first two consecutive threads. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact. Bone levels will be measured.	At 1,3 and 5 years
Valuation of patient satisfaction	Patients will answer the following questions (separately for each implant): Are you satisfied with the function of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not.; Are you satisfied with the aesthetic outcome of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not.; Would you undergo the same therapy again? Possible answers: "yes" or "no".	At 1,3 and 5 years
Rate of implant stability quotient (ISQ)	ISQ was measured and recorded using the IS3 (Osstem), at implant placement, at implants exposure, at the impression time, and prosthetic loading.	Up to 5 years
Valuation of soft tissue thickness and amount of keratinized tissue	The soft tissue biotype will be investigated by the same surgeon at the surgical procedures using a periodontal probe into the sulcus. Greater will be the thickness of the tissue, smaller will be transparency of the periodontal probe. The amount of keratinized tissue will be evaluated 1 year after surgical procedures using a periodontal probe. This outcome will be evaluated according to the distance from the gingival margin to the mucogingival junction	1,3 and 5 years
Number of PES score	Esthetic evaluation of occlusal and vestibular pictures will take every years after definite loading was done following the pink esthetic score (PES). In brief, the PES score evaluates seven variables: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiencies, soft tissue color and texture. A 0-1-2 scoring system was used, 0 being the lowest and 2 being the highest value, with a maximum achievable score of 14 per dental unit.	1,3 and 5 years

Collaborators and Investigators

• Sponsor: Università degli Studi di Sassari
• Collaborators: Dr. Dario Melodia; Dr. Milena Pisano; Prof. Silvio Mario Meloni; Prof. Edoardo Baldoni; Dr. Aurea M. I. Lumbau

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Dental Implant; Implant-abutment connection; Immediately vs Delayes
• Other Study ID Numbers: UNISS_PHD_Osstem_3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No