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NCT Number: NCT06276712

RCT Comparing KS Versus TS for Ovedenture

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

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Key information

Conditions

Dental Implant Dental Implant-Abutment Design Edentulous Jaw Jaw Diseases Jaw, Edentulous Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implant placement with 3.5 mm diameter KS implants.

Device

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.

Implant placement with 3.5 mm diameter TS implants.

Device

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 outcomes

  1. Number of 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.

  2. Number of 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 reaso

  3. Number of complications

    Time frame: Up to 5 years

    echnical (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.

  4. Rate of implant stability

    Time frame: Up to 5 years

    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.

Secondary outcomes

  1. 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.

  2. Patient satisfaction

    Time frame: At 1,3 and 5 years

    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".

Sponsors and collaborators

Lead sponsor

Università degli Studi di Sassari

Other

Collaborators

  • Baldoni, Edoardo, M.D.
  • Dr. Aurea Lumbau
  • Melodia, Dario, M.D.
  • Meloni, Silvio Mario, M.D.
  • Pisano, Milena, M.D.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2028
First posted
Feb 26, 2024
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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