Clinical trial NCT05859113: Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic Connection
Official title: Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic Connection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Jaw, Edentulous, Partially
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 42
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: Dental implants may suffer from bone loss around them, particularly at the upper portion where the prosthesis starts. The connection between both parts of the tooth restoration is key for avoiding micromovement during chewing, bacterial contamination and initiation of bone loss. Thus, investigating factors related to this bone loss in different types of implant-prosthetic connections is key for promoting better use of available therapeutics devices. In this study, we will study marginal bone levels over time as well as bacterial contamination and inflammatory markers in the peri-implant sulcus around implants with connical connection and compare them with those obtained when using implants with internal hexagonal connection. The hypothesis is that bone loss will be higher in implants with hexagonal connection associated with a pathological microbiome in the sulcus that induces a higher inflammatory response.


Eligibility criteria: Inclusion Criteria:

* 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 microbiome
timeFrame: 1 year
measure: Peri-implant inflammation
timeFrame: 1 year
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Universidad de Granada
Study officials:
References:
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.