Comparison KS Versus TS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implant placement TS III, Implant placement ks.
- Who it may be relevant to
- Registry conditions: Dental Implant, Dental Implant-Abutment Design. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Use of an Innovative, Thickened and Lasting Implant Comparing KS Versus TS Implants for Prosthetic Rehabilitations
Overview
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).
Interventions
- Device Implant placement TS III
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. - Device Implant placement ks
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.
Primary outcome measures
- Number of Participants with implant failure [Time frame: Up to 5 years]
- Number of Participants with prosthesis failure [Time frame: Up to 5 years]
- Number of complications [Time frame: Up to 5 years]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
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.
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.
- 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.
- 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
- Double blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Marco Tallarico — Sassari
Identifiers
NCT: NCT05843981 · UNISS_PHD_Osstem_1