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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02975674
Other study ID # 213CEIH2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date February 2021

Study information

Verified date May 2023
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 2021
Est. primary completion date February 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
MT-12 dental implant
Placement of the MT-12 dental implant with Morse taper implant-abutment connection
CON.INT dental implant
Placement of the CON.INT dental implant with internal hexagon implant-abutment connection

Locations

Country Name City State
Spain Facultad de Odontología Granada

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. 2 — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Marginal bone level 1 year
Secondary Peri-implant inflammation 1 year
Secondary Peri-implant microbial contamination 1 year
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