NCT02975674

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

4.3 years

First QC Date

November 23, 2016

Last Update Submit

May 20, 2023

Conditions

Jaw, Edentulous, Partially

Outcome Measures

Primary Outcomes (1)

  • Marginal bone level

    1 year

Secondary Outcomes (2)

  • Peri-implant inflammation

    1 year

  • Peri-implant microbial contamination

    1 year

Study Arms (2)

MT-12 dental implant

EXPERIMENTAL

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

Device: MT-12 dental implant

CON.INT dental implant

ACTIVE COMPARATOR

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

Device: CON.INT dental implant

Interventions

MT-12 dental implantDEVICE

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

MT-12 dental implant
CON.INT dental implantDEVICE

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

CON.INT dental implant

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient \>18 and ≤75 years old
  • One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal)

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Odontología

Granada, 18071, Spain

Location

Related Publications (2)

  • 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.

    PMID: 25830399BACKGROUND

  • 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.

    PMID: 34830709RESULT

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Officials

  • Pablo Galindo-Moreno, DDS, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 29, 2016

Study Start

November 1, 2016

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations

ES(1)