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Active, not recruitingNCT05859113Updated May 12, 2026

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

An interventional study of Ziacom Galaxy dental implant with internal connical prosthetic connection and Ziacom Zinic dental implant with internal hexagonal prosthetic connection in Jaw, Edentulous, Partially, sponsored by Universidad de Granada. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Jaw, Edentulous, Partially
03

In context

Jaw, Edentulous, Partially

66 studies on the registry are indexed under Jaw, Edentulous, Partially; 7 are open to participants now.

This study's planned enrollment of 42 is above the median of 36 across 58 interventional studies indexed under Jaw, Edentulous, Partially.

Browse Jaw, Edentulous, Partially studies →

Lead sponsor

Universidad de Granada is the lead sponsor of 241 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Ziacom Galaxy dental implant with internal connical prosthetic connection

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

    Device: Ziacom Galaxy dental implant with internal connical prosthetic connection

  • Active comparator
    Ziacom Zinic dental implant with internal hexagonal prosthetic connection

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

    Device: Ziacom Zinic dental implant with internal hexagonal prosthetic connection

Interventions

  • DeviceZiacom Galaxy dental implant with internal connical prosthetic connection

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

  • DeviceZiacom Zinic dental implant with internal hexagonal prosthetic connection

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

06

What researchers measure

Primary outcomes

  1. Marginal bone level

    Time frame: 1 year

Secondary outcomes

  1. Peri-implant microbiome

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

    Time frame: 1 year

  2. Peri-implant inflammation

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

    Time frame: 1 year

07

Study locations

1 site
  • Universidad de Granada
    Granada, Granada 18071, Spain
08

References and documents

Publications

  • 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. PubMed 34830709 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05859113
Lead sponsor
Universidad de Granada
Responsible party
Miguel Padial-Molina (Associate Professor, Universidad de Granada) — Principal investigator
First posted
May 15, 2023
Start date
Jul 10, 2023
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 12, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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