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

Primary Purpose

Jaw, Edentulous, Partially

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
MT-12 dental implant
CON.INT dental implant
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Facultad de Odontología

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MT-12 dental implant

CON.INT dental implant

Arm Description

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

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

Outcomes

Primary Outcome Measures

Marginal bone level

Secondary Outcome Measures

Peri-implant inflammation
Peri-implant microbial contamination

Full Information

First Posted
November 23, 2016
Last Updated
May 20, 2023
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT02975674
Brief Title
Evaluation of MT-12 Implant Survival and Marginal Bone Loss
Acronym
213CEIH2016
Official Title
Evaluation of MT-12 Implant Survival and Marginal Bone Loss
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
February 2021 (Actual)
Study Completion Date
February 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT-12 dental implant
Arm Type
Experimental
Arm Description
MT-12 dental implant with Morse taper implant-abutment connection
Arm Title
CON.INT dental implant
Arm Type
Active Comparator
Arm Description
CON.INT dental implant with internal hexagon implant-abutment connection
Intervention Type
Device
Intervention Name(s)
MT-12 dental implant
Intervention Description
Placement of the MT-12 dental implant with Morse taper implant-abutment connection
Intervention Type
Device
Intervention Name(s)
CON.INT dental implant
Intervention Description
Placement of the CON.INT dental implant with internal hexagon implant-abutment connection
Primary Outcome Measure Information:
Title
Marginal bone level
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Peri-implant inflammation
Time Frame
1 year
Title
Peri-implant microbial contamination
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Galindo-Moreno, DDS, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facultad de Odontología
City
Granada
ZIP/Postal Code
18071
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25830399
Citation
Galindo-Moreno P, Fernandez-Jimenez A, O'Valle F, Monje A, Silvestre FJ, Juodzbalys G, Sanchez-Fernandez E, Catena A. Influence of the crown-implant connection on the preservation of peri-implant bone: a retrospective multifactorial analysis. Int J Oral Maxillofac Implants. 2015 Mar-Apr;30(2):384-90. doi: 10.11607/jomi.3804.
Results Reference
background
PubMed Identifier
34830709
Citation
Galindo-Moreno P, Concha-Jeronimo A, Lopez-Chaichio L, Rodriguez-Alvarez R, Sanchez-Fernandez E, Padial-Molina M. Marginal Bone Loss around Implants with Internal Hexagonal and Internal Conical Connections: A 12-Month Randomized Pilot Study. J Clin Med. 2021 Nov 20;10(22):5427. doi: 10.3390/jcm10225427.
Results Reference
result

Learn more about this trial

Evaluation of MT-12 Implant Survival and Marginal Bone Loss

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