Clinical trial NCT02975674: Evaluation of MT-12 Implant Survival and Marginal Bone Loss
Official title: Evaluation of MT-12 Implant Survival and Marginal Bone Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Marginal bone level
timeFrame: 1 year
Secondary outcomes:
measure: Peri-implant inflammation
timeFrame: 1 year
measure: Peri-implant microbial contamination
timeFrame: 1 year
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Facultad de Odontología
Study officials:
affiliation: Universidad de Granada
name: Pablo Galindo-Moreno, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.