Comparison KS Versus TS

NCT05843981 | Not Yet Recruiting

• 1 other identifier: UNISS_PHD_Osstem_1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the clinical and radiographic outcomes of two different implant systems with different implant-abutment connection: Osstem TS III (control group) versus Osstem KS (study group).

Conditions

Dental Implant; Dental Implant-Abutment Design

Keywords

Dental Implant-Abutment Design; KS dental implant; Implant-abutment connection

Outcome Measures

Primary Outcomes (3)

• Number of Participants with 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 at initial loading. At 1,3 and 5 years after loading, individual implants will be manually tested for stability. Once the single crowns will be screwed, their stability will be assessed by rocking the crown with the handles of two dental instruments.

  Up to 5 years

• Number of Participants with 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 complications

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

  Up to 5 years

Secondary Outcomes (2)

• Rate of peri-implant marginal bone level changes

  At 1,3 and 5 years

• Valuation of patient satisfaction

  At 1,3 and 5 years

Study Arms (2)

Ks dental implant

EXPERIMENTAL

Innovative dental implant with lasting, internal conical connection of 15° and strengthened implant walls.

Device: Implant placement ks

TSIII dental implant

ACTIVE COMPARATOR

Standard dental implant with internal conical connection of 11°.

Device: Implant placement TS III

Interventions

Implant placement TS III DEVICE

Implant placement in subjects who have lost at least two teeth and need a prosthetic implant rehabilitation with TSIII Implant. . After osseointegration, dental implants will receive definitive prosthesis.

Also known as: Dental prosthesis delivery

TSIII dental implant

Implant placement ks DEVICE

Implant placement in subjects who have lost at least two teeth and need a prosthetic implant rehabilitation with KS Implant. After osseointegration, dental implants will receive definitive prosthesis.

Also known as: Dental prosthesis delivery

Ks dental implant

Eligibility Criteria

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

You may qualify if:

• Any partially edentulous patient with partial edentulism, requiring at least two dental implant-supported rehabilitations, being 18 years or older, and able to sign an informed consent. Implant sites must allow the placement of two implants of at least 4 (premolars) or 4.5 (molars) mm of diameter and 8.5 mm of length. 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). In case of post-extractive sites, they must have been healing for at least 3 months before being treated in the study. Implants can be adjacent.

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.
• Previous guided bone reconstruction at the intended implant sites.
• Uncontrolled diabetes.
• 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 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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients, the outcome assessors (when possible) and the statistical advisors will be blind to the used implant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Split-mouth

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: March 1, 2024
• Primary Completion: December 31, 2024
• Study Completion (Estimated): January 31, 2028
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)