RCT Comparing KS Versus TS for Ovedenture

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Implant; Dental Implant-Abutment Design; Edentulous Jaw
• Intervention / Treatment: Device: Implant placement with 3.5 mm diameter KS implants.; Device: Implant placement with 3.5 mm diameter TS implants.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
Active Comparator: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-implant marginal bone level changes	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
Patient satisfaction	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".	At 1,3 and 5 years

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Dental Implant; Overdenture; Implant-abutment connection
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous
• Other Study ID Numbers: UNISS_PHD_Osstem_5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No