Comparison KS Versus TS

February 21, 2024 updated by: Marco Tallarico, Università degli Studi di Sassari

The Use of an Innovative, Thickened and Lasting Implant Comparing KS Versus TS Implants for Prosthetic Rehabilitations

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ks dental implant
Innovative dental implant with lasting, internal conical connection of 15° and strengthened implant walls.
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.
Other Names:
  • Dental prosthesis delivery
Active Comparator: TSIII dental implant
Standard dental implant with internal conical connection of 11°.
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.
Other Names:
  • Dental prosthesis delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with implant failure
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of peri-implant marginal bone level changes
Time Frame: At 1,3 and 5 years
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
Time Frame: At 1,3 and 5 years

Patients will answer the following questions (separately for each implant):

  1. Are you satisfied with the function of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not.
  2. Are you satisfied with the aesthetic outcome of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not.
  3. Would you undergo the same therapy again? Possible answers: "yes" or "no".
At 1,3 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Sassari

Collaborators

Dr. Dario Melodia
Dr. Milena Pisano
Dr. Aurea Lumbau
Prof. Silvio Mario Meloni
Prof. Edoardo Baldoni

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

April 24, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UNISS_PHD_Osstem_1

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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