Jaw, Edentulous, Partially
Conditions
Brief summary
The trial is designed as a consecutive enrollment prospective one-center study. A minimum of 30 patients will be included in the study. At implant installation, the patient will be randomized to receive one of the two types of implants (Control: internal hexagon connection implants (CON.INT); Test: Morse taper connection implants (MT-12)). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be collected at -21 (second-stage surgery), -14 (impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the impressions are taken.
Interventions
DEVICEMT-12 dental implant
Placement of the MT-12 dental implant with Morse taper implant-abutment connection
DEVICECON.INT dental implant
Placement of the CON.INT dental implant with internal hexagon implant-abutment connection
Sponsors
Universidad de Granada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient \>18 and ≤75 years old * One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal)
Exclusion criteria
* One-stage bone augmentation * Uncontrolled type 1 or 2 diabetes (HgA1c\>8) * Known auto-immune or inflammatory disease * Severe hematologic disorders, such as hemophilia or leukemia * Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology) * Liver or kidney dysfunction/failure * Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy * Long-term history of oral bisphosphonates use (i.e., 10 years or more) * History of intravenous bisphosphonates * Long-term (\>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system 3 months before inclusion * Severe osseous diseases (e.g., Paget disease of bone) * Pregnant women or nursing mothers * Not able or not willing to follow instructions related to the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Marginal bone level | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Peri-implant inflammation | 1 year |
| Peri-implant microbial contamination | 1 year |
Countries
Spain
Outcome results
None listed