Clinical trial NCT06276712: RCT Comparing KS Versus TS for Ovedenture
Official title: A Randomized Controlled Trial Comparing Titanium Grade V (KS) Versus Titanium Grade IV (TS) Implants for the Treatment of Edentulous Mandible
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Implant
Dental Implant-Abutment Design
Edentulous Jaw
Keywords: Dental Implant
Overdenture
Implant-abutment connection
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
Collaborators: name: Melodia, Dario, M.D.
name: Pisano, Milena, M.D.
name: Dr. Aurea Lumbau
name: Prof. Silvio Mario Meloni
name: Prof. Edoardo Baldoni
First posted: 2024-02-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicenters, randomized controlled trial.
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of implant failure
timeFrame: Up to 5 years
measure: Number of prosthesis failure
timeFrame: Up to 5 years
measure: Number of complications
timeFrame: Up to 5 years
measure: Rate of implant stability
timeFrame: Up to 5 years
Secondary outcomes:
measure: Peri-implant marginal bone level changes
timeFrame: At 1,3 and 5 years
measure: Patient satisfaction
timeFrame: At 1,3 and 5 years
Other outcomes:
Locations:
Study officials:
References: