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

Jaw, Edentulous, Partially Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05859113
• Other study ID #: 2978/CEIH/2022
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 30, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

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

Locations

Country	Name	City	State
Spain	Universidad de Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal bone level		1 year
Secondary	Peri-implant microbiome	Relative abundance of microbial species in the peri-implant sulcus evaluated by next-generation sequencing methods	1 year
Secondary	Peri-implant inflammation	Concentration of pro-inflammatory markers in the peri-implant sulcus evaluated by multiplex techniques methods	1 year