RCT Comparing KS Versus TS for Ovedenture

NCT06276712 | Not Yet Recruiting

• 1 other identifier: UNISS_PHD_Osstem_5
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dental Implant; Dental Implant-Abutment Design; Edentulous Jaw

Keywords

Dental Implant; Overdenture; Implant-abutment connection

Outcome Measures

Primary Outcomes (4)

• Number of 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.

  Up to 5 years

• Number of 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 reaso

  Up to 5 years

• Number of complications

  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.

  Up to 5 years

• Rate of implant stability

  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

Secondary Outcomes (2)

• Peri-implant marginal bone level changes

  At 1,3 and 5 years

• Patient satisfaction

  At 1,3 and 5 years

Study Arms (2)

Ks dental implant

EXPERIMENTAL

Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants using KS implant with 3.5 mm of diameter

Device: Implant placement with 3.5 mm diameter KS implants.

TS dental implant

ACTIVE COMPARATOR

Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants using TS implant with 3.5 mm of diameter

Device: Implant placement with 3.5 mm diameter TS implants.

Interventions

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.

Ks dental implant

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.

TS 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 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.
• 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.

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

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded (when possible) outcome assessor will evaluate all the outcomes and will take the radiogram for centralized analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistent Professor

Model Details: A multicenters, randomized controlled trial.

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: February 26, 2024
• Study Start: March 1, 2024
• Primary Completion: December 30, 2024
• Study Completion (Estimated): January 30, 2028
• Last Updated: February 26, 2024

Record last verified: 2024-02