Evaluation of MT-12 Implant Survival and Marginal Bone Loss (213CEIH2016)

University of Granada (UGR)

Status: Completed

Conditions: Jaw, Edentulous, Partially

Treatments: Device: CON.INT dental implant; Device: MT-12 dental implant

Study type: Interventional

Funder types: Other

Identifiers

NCT02975674

213CEIH2016

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

MT-12 dental implant

Experimental group

Description:

MT-12 dental implant with Morse taper implant-abutment connection

Treatment:

Device: MT-12 dental implant

CON.INT dental implant

Active Comparator group

Description:

CON.INT dental implant with internal hexagon implant-abutment connection

Treatment:

Device: CON.INT dental implant