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Completed

NCT Number: NCT02975674

Evaluation of MT-12 Implant Survival and Marginal Bone Loss

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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Key information

Conditions

Jaw, Edentulous, Partially Jaw Diseases Jaw, Edentulous Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de Odontología

Granada, 18071, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT-12 dental implant

Device

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

CON.INT dental implant

Device

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

Primary outcomes

  1. Marginal bone level

    Time frame: 1 year

Secondary outcomes

  1. Peri-implant inflammation

    Time frame: 1 year

  2. Peri-implant microbial contamination

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Acronym: 213CEIH2016

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Nov 29, 2016
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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