Ireland
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Active, not recruiting Not applicable

Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic Connection

NCT05859113 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2023-07-10
Last updated
2026-05-12

Condition(s) studied

Jaw, Edentulous, Partially

Investigational drug(s) / intervention(s)

Ziacom Galaxy dental implant with internal connical prosthetic connectionZiacom Zinic dental implant with internal hexagonal prosthetic connection

Ziacom Galaxy dental implant with internal connical prosthetic connection: Placement and restoration of a single Ziacom Galaxy dental implant with internal connical prosthetic connection

Ziacom Zinic dental implant with internal hexagonal prosthetic connection: Placement and restoration of a single Ziacom Zinic dental implant with internal hexagonal prosthetic connection

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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 outcome measure(s)

  • Marginal bone level — 1 year

Trial sites (1)

FacilityCityRegionStatus
Universidad de Granada Granada Granada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05859113 on ClinicalTrials.gov ↗ ← All trials in Spain