RCT Comparing KS Versus TS for Ovedenture

NCT ID: NCT06276712

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2028-01-30

Brief Summary

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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

Detailed Description

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Conditions

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Dental Implant Dental Implant-Abutment Design Edentulous Jaw

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A multicenters, randomized controlled trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
A blinded (when possible) outcome assessor will evaluate all the outcomes and will take the radiogram for centralized analysis.

Study Groups

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Ks dental implant

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

Group Type EXPERIMENTAL

Implant placement with 3.5 mm diameter KS implants.

Intervention Type 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.

TS dental implant

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

Group Type ACTIVE_COMPARATOR

Implant placement with 3.5 mm diameter TS implants.

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Melodia, Dario, M.D.

INDIV

Sponsor Role collaborator

Pisano, Milena, M.D.

INDIV

Sponsor Role collaborator

Dr. Aurea Lumbau

UNKNOWN

Sponsor Role collaborator

Prof. Silvio Mario Meloni

UNKNOWN

Sponsor Role collaborator

Prof. Edoardo Baldoni

UNKNOWN

Sponsor Role collaborator

Università degli Studi di Sassari

OTHER

Sponsor Role lead

Responsible Party

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Marco Tallarico

Assistent Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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UNISS_PHD_Osstem_5

Identifier Type: -

Identifier Source: org_study_id

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