Evaluation of MT-12 Implant Survival and Marginal Bone Loss

Not Applicable

Completed

• Conditions: Jaw, Edentulous, Partially
• Interventions: Device: MT-12 dental implant; Device: CON.INT dental implant

• Registration Number: NCT02975674
• Lead Sponsor: Universidad de Granada

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-29
• Primary Completion: 2021-02
• Study Completion: 2021-02
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-20
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MT-12 dental implant	MT-12 dental implant	MT-12 dental implant with Morse taper implant-abutment connection
CON.INT dental implant	CON.INT dental implant	CON.INT dental implant with internal hexagon implant-abutment connection

Primary Outcome Measures

Name	Time	Method
Marginal bone level	1 year

Secondary Outcome Measures

Name	Time	Method
Peri-implant microbial contamination	1 year
Peri-implant inflammation	1 year

Trial Locations

Locations (1)

Facultad de Odontología; 🇪🇸 Granada, Spain