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

Last updated: December 3, 2024
Sponsor: Universidad de Granada
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Ziacom Galaxy dental implant with internal connical prosthetic connection

Ziacom Zinic dental implant with internal hexagonal prosthetic connection

Clinical Study ID

NCT05859113
2978/CEIH/2022
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

Inclusion Criteria:

  • One missing tooth in the premolar or molar area with both opposing and adjacentteeth (mesial and distal).

Exclusion

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., extensiveperiapical 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 theinflammation 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

Total Participants: 42
Treatment Group(s): 2
Primary Treatment: Ziacom Galaxy dental implant with internal connical prosthetic connection
Phase:
Study Start date:
July 10, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Universidad de Granada

    Granada, 18071
    Spain

    Active - Recruiting

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