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Active, Not Recruiting

NCT Number: NCT05859113

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Jaw, Edentulous, Partially Jaw Diseases Jaw, Edentulous Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Granada

Granada, 18071, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ziacom Galaxy dental implant with internal connical prosthetic connection

Device

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

Ziacom Zinic dental implant with internal hexagonal prosthetic connection

Device

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

Primary outcomes

  1. Marginal bone level

    Time frame: 1 year

Secondary outcomes

  1. Peri-implant microbiome

    Time frame: 1 year

    Relative abundance of microbial species in the peri-implant sulcus evaluated by next-generation sequencing methods

  2. Peri-implant inflammation

    Time frame: 1 year

    Concentration of pro-inflammatory markers in the peri-implant sulcus evaluated by multiplex techniques methods

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 15, 2023
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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