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Not yet recruiting NCT06276712

RCT Comparing KS Versus TS for Ovedenture

No phase Interventional Dental Implant Dental Implant-Abutment Design Edentulous Jaw

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 with 3.5 mm diameter KS implants., Implant placement with 3.5 mm diameter TS implants..
Who it may be relevant to
Registry conditions: Dental Implant, Dental Implant-Abutment Design, Edentulous Jaw. 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Randomized Controlled Trial Comparing Titanium Grade V (KS) Versus Titanium Grade IV (TS) Implants for the Treatment of Edentulous Mandible

Overview

To evaluate the clinical and radiographic outcomes of KS implants used to rehabilitate edentulous mandible with dental-retained overdentures, and to compare it with same treatment on TS implants

Interventions

  • Device Implant placement with 3.5 mm diameter KS implants.
    Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants. with 3.5 mm diameter KS implants.After osseointegration, both dental implants will receive definitive prosthesis.
  • Device Implant placement with 3.5 mm diameter TS implants.
    Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants. with 3.5 mm diameter TS implants.After osseointegration, both dental implants will receive definitive prosthesis.

Primary outcome measures

  • Number of implant failure [Time frame: Up to 5 years]
  • Number of prosthesis failure [Time frame: Up to 5 years]
  • Number of complications [Time frame: Up to 5 years]
  • Rate of implant stability [Time frame: Up to 5 years]
Secondary outcome measures (2)
  • Peri-implant marginal bone level changes [Time frame: At 1,3 and 5 years]
  • Patient satisfaction [Time frame: At 1,3 and 5 years]

Eligibility criteria

Inclusion criteria

  • Any edentulous patient (post-extractive sites must to be healed from at least 3 months), with sufficient bone height and width in the anterior mandible (between canines) to allow the placement of two implants of 3.5 mm diameter of at least 8.5 mm of length.
  • 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).
  • In case of post-extractive sites, they must have been healing for at least 3 months before being treated in the study.

Exclusion criteria

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
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06276712 · UNISS_PHD_Osstem_5

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗