Evaluation of MT-12 Implant Survival and Marginal Bone Loss

Jaw, Edentulous, Partially Clinical Trial

— 213CEIH2016  

Official title:

Evaluation of MT-12 Implant Survival and Marginal Bone Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02975674
• Other study ID #: 213CEIH2016
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

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