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.

Study Overview

• Status: Recruiting
• Conditions: Jaw, Edentulous, Partially
• Intervention / Treatment: Device: Ziacom Galaxy dental implant with internal connical prosthetic connection; Device: Ziacom Zinic dental implant with internal hexagonal prosthetic connection

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18071
    • Recruiting
    • Universidad de Granada
    • Contact: Miguel Padial-Molina, DDS, PhD; Email: mipadial@ugr.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Placement and restoration of a single 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; Placement and restoration of a single Ziacom Zinic dental implant with internal hexagonal prosthetic connection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Marginal bone level	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-implant microbiome	Relative abundance of microbial species in the peri-implant sulcus evaluated by next-generation sequencing methods	1 year
Peri-implant inflammation	Concentration of pro-inflammatory markers in the peri-implant sulcus evaluated by multiplex techniques methods	1 year

Collaborators and Investigators

• Sponsor: Universidad de Granada

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 15, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous; Jaw, Edentulous, Partially
• Other Study ID Numbers: 2978/CEIH/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No