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

May 20, 2023 updated by: Pablo Galindo-Moreno, Universidad de Granada
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18071
        • Facultad de Odontología

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MT-12 dental implant
MT-12 dental implant with Morse taper implant-abutment connection
Device: MT-12 dental implant
Placement of the MT-12 dental implant with Morse taper implant-abutment connection
Active Comparator: CON.INT dental implant
CON.INT dental implant with internal hexagon implant-abutment connection
Device: CON.INT dental implant
Placement of the CON.INT dental implant with internal hexagon implant-abutment connection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Marginal bone level
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Peri-implant inflammation
Time Frame: 1 year
1 year
Peri-implant microbial contamination
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

Investigators

  • Principal Investigator: Pablo Galindo-Moreno, DDS, PhD, Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 20, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 213CEIH2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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