NCT05859113

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 10, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

2.4 years

First QC Date

May 2, 2023

Last Update Submit

December 3, 2024

Conditions

Jaw, Edentulous, Partially

Outcome Measures

Primary Outcomes (1)

  • Marginal bone level

    1 year

Secondary Outcomes (2)

  • Peri-implant microbiome

    1 year

  • Peri-implant inflammation

    1 year

Study Arms (2)

Ziacom Galaxy dental implant with internal connical prosthetic connection

EXPERIMENTAL

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

Ziacom Zinic dental implant with internal hexagonal prosthetic connection

ACTIVE COMPARATOR

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

Ziacom Galaxy dental implant with internal connical prosthetic connectionDEVICE

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

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

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

Ziacom Zinic dental implant with internal hexagonal prosthetic connection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Granada

Granada, 18071, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34830709BACKGROUND

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 2, 2023

First Posted

May 15, 2023

Study Start

July 10, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)