Clinical Assessment of Dental Implant (H2015-1)

University of Liege

Status: Completed

Conditions: Tooth Loss

Treatments: Device: MIS Implants

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02591706

H2015-1

Details and patient eligibility

About

Primary Endpoints : The implant survival and success rate of V3 and C1 implants will be compared. Implant success rate will be evaluated by measuring the peri-implant bone remodeling from baseline to 1 year post insertion.

The hypothesis is those implant survival rates of the test (V3) and control group (C1) are similar and that test V3 implant allows less peri-implant bone loss.

Secondary Endpoints : The thickness of hard tissue in the buccal aspect of the V3 and C1 implants will be compared. The bone thickness will be measured in cone beam computerized tomography (CBCT) on the day of implantation, 4 and at one year after the final restoration.

The hypothesis is that V3 implant allows thicker bone dimension in the cervical area.

Enrollment: 34 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject must have voluntarily signed the informed consent form before any study related action
• Age: 18 with one or more missing teeth in the maxillary area, seeking for implant therapy.
• Men/Women
• In good systemic health (ASA I/ II)
• Present with no contra indication against oral surgical interventions
• Patients required replacement of a single missing tooth. The tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation.
• At least 10 mm of bone in the vertical dimension
• At least 6 mm of bone in the bucco-lingual dimension.
• No need for bone augmentation procedure in any of the dimensions
• Full mouth plaque score (FMPI) lower or equal than 25%

Exclusion criteria

• Autoimmune disease require medical treatment
• Medical conditions requiring prolonged use of steroids
• Use of Bisphosphonate intravenously or more then
• Infection (local or systemic) - patient with gingivitis or active local infection will undergo a medical treatment prior to his entrance to the study, each individual will be evaluated prior to study procedure for suitability, in case of systemic infection the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
• Current pregnancy or breastfeeding women
• Alcoholism or chronically drug abuse
• Immunocompromised patients
• Uncontrolled Diabetes
• Smokers
• Prisoners

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Dental implant (C1)

Active Comparator group

Description:

Internal Conical Connection: The C1 has a six-position cone index, except for the C1 narrow platform that has a four-position cone index. The conical connection is 2.00mm in depth, with a 12° cone. As a result of our meticulous manufacturing process a perfect fit between the implant and the abutment is achieved, eliminating micro-movements and minimizing bone resorption. Patient will be randomly assigned to one of the two groups after flap opening.

Treatment:

Device: MIS Implants

Dental implant (V3)

Experimental group

Description:

The unique triangular shape of the coronal portion of the V3 implant results in less titanium and more bone and soft tissue visible in the esthetic zone, for a restorative-driven approach and easier soft tissue management. The V3 provides doctors with a more advantageous starting point; where greater volume of bone and soft tissue is achieved at the onset of implant placement. Patient will be randomly assigned to one of the two groups after flap opening.

Treatment:

Device: MIS Implants