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

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ClinicalTrials.gov Identifier: NCT02975674
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Pablo Galindo-Moreno, 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.

Condition or disease Intervention/treatment Phase
Jaw, Edentulous, Partially Device: MT-12 dental implant Device: CON.INT dental implant Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of MT-12 Implant Survival and Marginal Bone Loss
Study Start Date : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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




Primary Outcome Measures :
  1. Marginal bone level [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Peri-implant inflammation [ Time Frame: 1 year ]
  2. Peri-implant microbial contamination [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975674


Contacts
Contact: Miguel Padial-Molina, DDS, PhD mipadial@ugr.es

Locations
Spain
Facultad de Odontología Recruiting
Granada, Spain, 18071
Contact: Miguel Padial-Molina, DDS, PhD       mipadial@ugr.es   
Principal Investigator: Pablo Galindo-Moreno, DDS, PhD         
Sub-Investigator: Miguel Padial-Molina, DDS, PhD         
Sponsors and Collaborators
Universidad de Granada
Investigators
Principal Investigator: Pablo Galindo-Moreno, DDS, PhD Universidad de Granada

Publications:
Responsible Party: Pablo Galindo-Moreno, Professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT02975674     History of Changes
Other Study ID Numbers: 213CEIH2016
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw, Edentulous, Partially
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth, Edentulous
Mouth Diseases
Tooth Diseases