Clinical trial NCT02591706: Clinical Assessment of Dental Implant
Official title: Clinical and Radiographic Assessment of V3 Implant: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Loss
Keywords: Single missing tooth
Implants
Peri-implant bone remodeling
Bone thickness
Thickness of soft tissue
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: MIS Implant Technologies, Ltd
First posted: 2015-10-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of implant survival and success rate of V3 and C1 implants
timeFrame: 1 year
Secondary outcomes:
measure: Comparison of the thickness of hard tissue in the buccal aspect of the V3 and C1 implants
timeFrame: 1 year
Other outcomes:
measure: Measurement of aesthetic outcomes based on the pink esthetic score
timeFrame: 1 year
Locations:
city: Liège
country: Belgium
facility: CHU de Liège - Service de Médecine Dentaire
Study officials:
affiliation: University of Liege
name: France LAMBERT
role: STUDY_DIRECTOR
References: