Evaluation of MT-12 Implant Survival and Marginal Bone Loss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2021-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Jaw, Edentulous, Partially

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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MT-12 dental implant

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

Group Type EXPERIMENTAL

MT-12 dental implant

Intervention Type DEVICE

Placement of the MT-12 dental implant with Morse taper implant-abutment connection

CON.INT dental implant

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

Group Type ACTIVE_COMPARATOR

CON.INT dental implant

Intervention Type DEVICE

Placement of the CON.INT dental implant with internal hexagon implant-abutment connection

Interventions

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MT-12 dental implant

Placement of the MT-12 dental implant with Morse taper implant-abutment connection

Intervention Type DEVICE

CON.INT dental implant

Placement of the CON.INT dental implant with internal hexagon implant-abutment connection

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes